| Primary | Change in Weekly Average Electronic Diary (eDiary) Numeric Rating Scale -Pain (NRS-Pain) Score From Randomization Baseline to Final 2 Weeks (Average of Weeks 11 and 12) | Weekly average diary NRS-Pain scores were derived from the daily NRS-pain scale and calculated as the mean of the last 7 days. NRS-Pain scores based on an 11-point numerical rating scale from 0 (no pain) to 10 (worst possible pain). Higher scores indicate greater pain. | Intent-to-Treat (ITT) Population: all participants who were randomized into the Double-Blind Treatment Period and received at least 1 dose of study drug after randomization; the averaged value for each participant from the 100 imputed datasets were used. Hybrid multiple and single imputation were applied, depending on reason for discontinuation. | Posted | | Least Squares Mean | Standard Error | Units on a Scale | | Weeks 11 and 12 | | | | ID | Title | Description |
|---|
| OG000 | ALO-02 To Placebo | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks. | | OG001 | ALO-02 To ALO-02 | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG0001.23± 0.179
- OG0010.60± 0.168
|
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| Null Hypothesis: No treatment difference. Power was 90%, 2-sided Alpha of 0.05, with assumed difference of 1 point and assumed standard deviation of 2.4 points. | ANCOVA | | 0.0114 | No adjustment was made for multiple comparisons. Statistical significance was if unadjusted p was less than or equal to (<=) 0.05. | Difference of LS Means | -0.62 | Standard Error of the Mean | 0.246 | 2-Sided | 95 | -1.11 | -0.14 | | | | | Superiority or Other | | |
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| Secondary | Change in Roland-Morris Disability Questionnaire (RMDQ) Total Score From Randomization Baseline to the End of Double-Blind Week 12 (or Final Visit). | The RMDQ is a 24-item questionnaire designed to measure self-rated disability due to back pain. An individual participant's score can vary from 0 (no disability) to 24 (severe disability), with a lower score indicating better function; higher score indicating greater disability. | ITT Population; imputation using last observation carried forward (LOCF) method. | Posted | | Least Squares Mean | Standard Error | Units on a Scale | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | ALO-02 To Placebo | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks. | | OG001 | ALO-02 To ALO-02 | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks. |
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| Secondary | Percentage (%) of Participants With Shift in Patient Global Assessment (PGA) by Category With Baseline PGA Score of Very Good (1), Good (2), Fair (3), Poor (4), Very Poor (5) From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit). | Measure represents the score at Randomization Baseline / score at Week 12 (or Early Termination) in PGA, a global evaluation that utilizes a 5-point Likert scale with a score of 1 being the best (Very Good) and a score of 5 being the worst (Very Poor). | ITT Population; percentage based on the number of participants who had non-missing values at Randomization Baseline and Week 12/early termination for each treatment. Imputation using LOCF method. | Posted | | Number | | Percentage of participants | | Randomization Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | ALO-02 To Placebo | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks. | | OG001 | ALO-02 To ALO-02 | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks. |
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| Secondary | Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction of Greater or Equal to (≥) 20% | Weekly average Diary NRS-pain scores are derived from the daily pain NRS and calculated as the mean of the last 7 days. Scores range from 0 equals (=) no pain to 10 = worst possible pain. Higher scores indicate greater pain. | | Posted | | Number | | percentage of participants | | Weeks 11 and 12 | | | | ID | Title | Description |
|---|
| OG000 | ALO-02 To Placebo | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks. | | OG001 | ALO-02 To ALO-02 | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks. |
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| Secondary | Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction ≥30% | Weekly average Diary NRS-pain scores are derived from the daily pain NRS and calculated as the mean of the last 7 days. Scores range from 0 = no pain to 10 = worst possible pain. Higher scores indicate greater pain. | | Posted | | Number | | percentage of participants | | Weeks 11 and 12 | | | | ID | Title | Description |
|---|
| OG000 | ALO-02 To Placebo | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks. | | OG001 | ALO-02 To ALO-02 | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks. |
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| Secondary | Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction ≥40% | Weekly average Diary NRS-pain scores are derived from the daily pain NRS and calculated as the mean of the last 7 days. Scores range from 0 = no pain to 10 = worst possible pain. Higher scores indicate greater pain. | | Posted | | Number | | percentage of participants | | Weeks 11 and 12 | | | | ID | Title | Description |
|---|
| OG000 | ALO-02 To Placebo | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks. | | OG001 | ALO-02 To ALO-02 | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks. |
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| Secondary | Percentage of Participants With Improvement in Weekly Average eDiary NRS-Pain Scores From Screening to Final 2 Weeks of the Double-Blind Treatment Period (Average of Weeks 11 and 12) by Cumulative Percent Reduction ≥50% | Weekly average Diary NRS-pain scores are derived from the daily pain NRS and calculated as the mean of the last 7 days. Scores range from 0 = no pain to 10 = worst possible pain. Higher scores indicate greater pain. | | Posted | | Number | | percentage of participants | | Weeks 11 and 12 | | | | ID | Title | Description |
|---|
| OG000 | ALO-02 To Placebo | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks. | | OG001 | ALO-02 To ALO-02 | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks. |
|
| Secondary | Change From Screening Period to End of Open-Label Treatment in Brief Pain Inventory - Short Form (BPI-sf): Worst Pain, Least Pain, Average Pain, Pain Right Now, Pain Severity Index, Pain Interference Index | BPI-sf is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions. BPI-sf includes 4 questions that assess pain intensity (worst, least, average, right now) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain. Pain Severity Index is the mean of the 4 pain scores (worst, least, average, and right now) on the BPI-sf; range is 0=No pain to 10=Pain as bad as you can imagine; A higher score indicates greater pain severity. Pain Interference Index is the mean of the scores for the 7 items of the BPI-sf; range is 0=Does not interfere to 10=Completely interferes. | Titration Period Safety Population: defined as all participants who received any amount of ALO-02 capsules during the Open-Label Conversion and Titration Period; imputation using the LOCF method. n=number of participants contributing to the mean for the specified parameter. | Posted | | Mean | Standard Deviation | Units on a Scale | | Screening, Week 4, 5, or 6 | | | | ID | Title | Description |
|---|
| OG000 | Open ALO-02 | Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. |
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| Secondary | Change From Screening Period to Randomization Baseline in BPI-sf: Worst Pain, Least Pain, Average Pain, Pain Right Now, Pain Severity Index, Pain Interference Index | BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain. Pain Severity Index is the mean of the 4 pain scores (worst, least, average, and right now) on the BPI-sf; range is 0=No pain to 10=Pain as bad as you can imagine; A higher score indicates greater pain severity. Pain Interference Index is the mean of the scores for the 7 items of the BPI-sf; range is 0=Does not interfere to 10=Completely interferes. | ITT Population - observed cases; n=number of participants assessed for the given parameter at the specified timepoint. | Posted | | Mean | Standard Deviation | units on scale | | Screening, Randomization Baseline | | | | ID | Title | Description |
|---|
| OG000 | Open ALO-02 | Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. |
| |
| Secondary | Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Worst Pain | BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain. | ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for worst pain at the specified timepoint. | Posted | | Least Squares Mean | Standard Error | Units on a Scale | | Weeks 2, 4, 8, and 12 | | | | ID | Title | Description |
|---|
| OG000 | ALO-02 To Placebo | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks. | | OG001 | ALO-02 To ALO-02 | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks. |
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| Secondary | Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Least Pain | BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain. | ITT Population - imputed values at early termination. Imputation by LOCF; n=number of participants assessed for least pain at the specified timepoint. | Posted | | Least Squares Mean | Standard Error | Units on a Scale | | Weeks 2, 4, 8, and 12 | | | | ID | Title | Description |
|---|
| OG000 | ALO-02 To Placebo | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks. | | OG001 | ALO-02 To ALO-02 | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks. |
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| Secondary | Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Average Pain | BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain. | ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for average pain at the specified timepoint. | Posted | | Least Squares Mean | Standard Error | Units on a Scale | | Weeks 2, 4, 8, and 12 | | | | ID | Title | Description |
|---|
| OG000 | ALO-02 To Placebo | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks. | | OG001 | ALO-02 To ALO-02 | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks. |
|
| Secondary | Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Right Now | BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain. | ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for pain right now at the specified timepoint. | Posted | | Least Squares Mean | Standard Error | Units on a Scale | | Weeks 2, 4, 8, and 12 | | | | ID | Title | Description |
|---|
| OG000 | ALO-02 To Placebo | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks. | | OG001 | ALO-02 To ALO-02 | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks. |
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| Secondary | Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Severity Index | Pain Severity Index is the mean of the 4 pain scores (worst, least, average, and right now) on the BPI-sf; range is 0=No pain to 10=Pain as bad as you can imagine; a higher score indicates greater pain severity. | ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for pain severity index at the specified timepoint. | Posted | | Least Squares Mean | Standard Error | Units on a Scale | | Weeks 2, 4, 8, and 12 | | | | ID | Title | Description |
|---|
| OG000 | ALO-02 To Placebo | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks. | | OG001 | ALO-02 To ALO-02 | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks. |
|
| Secondary | Change From Randomization Baseline to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Interference Index | Pain Interference Index is the mean of the scores for the 7 items of the BPI-sf; range is 0=Does not interfere to 10=Completely interferes. | ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for pain interference index at the specified timepoint. | Posted | | Least Squares Mean | Standard Error | Units on a Scale | | Weeks 2, 4, 8, and 12 | | | | ID | Title | Description |
|---|
| OG000 | ALO-02 To Placebo | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks. | | OG001 | ALO-02 To ALO-02 | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks. |
|
| Secondary | Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Worst Pain | BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain. | ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for worst pain at the specified timepoint. | Posted | | Least Squares Mean | Standard Error | Units on a Scale | | Weeks 2, 4, 8 and 12 | | | | ID | Title | Description |
|---|
| OG000 | ALO-02 To Placebo | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks. | | OG001 | ALO-02 To ALO-02 | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks. |
|
| Secondary | Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Least Pain | BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; Higher scores indicate greater pain. | ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for least pain at the specified timepoint. | Posted | | Least Squares Mean | Standard Error | Units on a Scale | | Weeks 2, 4, 8, and 12 | | | | ID | Title | Description |
|---|
| OG000 | ALO-02 To Placebo | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks. | | OG001 | ALO-02 To ALO-02 | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks. |
|
| Secondary | Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Average Pain | BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; higher scores indicate greater pain. | ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for average pain at the specified timepoint. | Posted | | Least Squares Mean | Standard Error | Units on a Scale | | Weeks 2, 4, 8, and 12 | | | | ID | Title | Description |
|---|
| OG000 | ALO-02 To Placebo | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks. | | OG001 | ALO-02 To ALO-02 | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks. |
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| Secondary | Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Right Now | BPI-sf scores range from 0=No pain to 10=Pain as bad as you can imagine; higher scores indicate greater pain. | ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for pain right now at the specified timepoint. | Posted | | Least Squares Mean | Standard Error | Units on a Scale | | Weeks 2, 4, 8, and 12 | | | | ID | Title | Description |
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| OG000 | ALO-02 To Placebo | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks. | | OG001 | ALO-02 To ALO-02 | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks. |
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| Secondary | Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Severity Index | Pain Severity Index is the mean of the 4 pain scores (worst, least, average, and right now) on the BPI-sf; range is 0=No pain to 10=Pain as bad as you can imagine; a higher score indicates greater pain severity. | ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for pain severity index at the specified timepoint. | Posted | | Least Squares Mean | Standard Error | Units on a Scale | | Weeks 2, 4, 8, and 12 | | | | ID | Title | Description |
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| OG000 | ALO-02 To Placebo | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks. | | OG001 | ALO-02 To ALO-02 | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks. |
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| Secondary | Change From Screening to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in BPI-sf Scores of Pain Interference Index | Pain Interference Index is the mean of the scores for the 7 items of the BPI-sf; range is 0=Does not interfere to 10=Completely interferes. | ITT Population - imputed values at early termination. Imputation using the LOCF method; n=number of participants assessed for pain interference index at the specified timepoint. | Posted | | Least Squares Mean | Standard Error | Units on a Scale | | Weeks 2, 4, 8, and 12 | | | | ID | Title | Description |
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| OG000 | ALO-02 To Placebo | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks. | | OG001 | ALO-02 To ALO-02 | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks. |
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| Secondary | Area Under the Curve (AUC) of eDiary NRS-Pain Scores From Randomization Baseline to Final 2 Weeks of the Double-Blind Treatment Period (Weeks 11 and 12) | NRS-Pain scores based on an 11-point numerical rating scale from 0 (no pain) to 10 (worst possible pain). AUC was calculated using daily change from Baseline scores from Baseline until the last dose date in the Double-Blind Treatment Period. AUC was calculated for each participant using the linear trapezoidal method. Higher scores indicate greater pain. | ITT Population; linear interpolation was used for internal missing values, with addition of 0 to the AUC for missing values from early discontinuation. | Posted | | Least Squares Mean | Standard Error | Change in units on a scale*days | | Randomization Baseline, Weeks 11 and 12 | | | | ID | Title | Description |
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| OG000 | ALO-02 To Placebo | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks. | | OG001 | ALO-02 To ALO-02 | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks. |
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| Secondary | Average Daily Use of Rescue Acetaminophen (Milligrams Per Day [mg/Day]) During the Double-Blind Treatment Period | The amount of acetaminophen administered for each treatment during the Double-Blind Treatment Period. Average daily use calculated as: total dose of rescue medication during Double-Blind Period divided by the number of days in Double-Blind Period. | | Posted | | Least Squares Mean | Standard Error | Average mg/day | | Daily from Day 1 of the Double-Blind Period through Week 12 | | | | ID | Title | Description |
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| OG000 | ALO-02 To Placebo | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks. | | OG001 | ALO-02 To ALO-02 | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks. |
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| Secondary | Percentage of Participants With a 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to End of Open-Label Treatment | The percentage of analgesic response is defined as: (rolling 7-day mean pain score during Titration Period - Screening Period pain intensity score) divided by Screening Period pain intensity score times100. | Titration Period Safety Population; an event was defined as a participant with 20%, 30%, 40%, or 50% analgesic response from Screening. | Posted | | Number | | Percentage of participants | | Screening, Week 4, 5 or 6 | | | | ID | Title | Description |
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| OG000 | Open ALO-02 | Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. |
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| Secondary | Median Time to 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to End of Open-Label Treatment | The percentage of analgesic response is defined as: (rolling 7-day mean pain score during Titration Period minus (-) Screening Period pain intensity score) divided by Screening Period pain intensity score times 100. An event was defined as a participant with 20, 30, 40, or 50% analgesic response from Screening. If there was no event for a participant, time to the event was considered censored at Day 42 of the Titration Period or before Day 42 of the Titration Period at the time of the last diary pain score. The survival duration begins on the date of first dose of study drug in the Titration Period and is calculated as the [date of event or last diary pain score - date of first dose in Titration Period +1]. | Titration Period Safety Population; an event was defined as a participant with 20%, 30%, 40%, or 50% analgesic response from Screening. | Posted | | Median | 95% Confidence Interval | days | | Screening, Week 4, 5, or 6 | | | | ID | Title | Description |
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| OG000 | Open ALO-02 | Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. |
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| Secondary | Percentage of Participants With a 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to Randomization Baseline | The percentage of analgesic response is defined as: (rolling 7-day mean pain score during Titration Period - Screening Period pain intensity score) divided by Screening Period pain intensity score times 100. | ITT Population; an event was defined as a participant with 20%, 30%, 40%, or 50% analgesic response from Screening. | Posted | | Number | | Percentage of participants | | Screening, Randomization Baseline (up to 6 weeks) | | | | ID | Title | Description |
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| OG000 | Open ALO-02 | Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. |
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| Secondary | Median Time to 20%, 30%, 40%, or 50% Analgesic Response From Screening Period to Randomization Baseline | The percentage of analgesic response is defined as: (rolling 7-day mean pain score during Titration Period - Screening Period pain intensity score) divided by Screening Period pain intensity score times 100. If there was no event for a participant, time to the event was considered censored at Day 42 of the Titration Period or before Day 42 of the Titration Period at the time of the last diary pain score. The survival duration begins on the date of first dose of study drug in the Titration Period and is calculated as the [date of event or last diary pain score - date of first dose in Titration Period +1]. | ITT Population; an event was defined as a participant with 20%, 30%, 40% or 50% analgesic response from Screening. | Posted | | Median | 95% Confidence Interval | days | | Screening, Randomization Baseline (up to 6 weeks) | | | | ID | Title | Description |
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| OG000 | Open ALO-02 | Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. |
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| Secondary | Percentage of Participants With a 20%, 30%, 40%, or 50% Loss of Analgesic Response From Randomization Baseline During the Double-Blind Treatment Period | The percentage of lost analgesic response is defined as: (rolling 7-day mean pain score during Double-Blind Period - Randomization Baseline pain intensity score) divided by Randomization Baseline pain intensity score times 100. If there was no event for a participant, time to the event was considered censored at Day 84 or before Day 84 at the time of the last diary pain score. The survival duration began on the date of first dose of study drug in the Double-Blind Period and was calculated as the [date of event or last diary pain score - date of first dose in Double-Blind Treatment +1]. | ITT Population; an event was defined as a participant with 20%, 30%, 40%, or 50% loss of analgesic response from Randomization Baseline. | Posted | | Number | | Percentage of participants | | Randomization Baseline, up to Week 12 | | | | ID | Title | Description |
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| OG000 | ALO-02 To Placebo | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks. | | OG001 |
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| Secondary | Median Time to 20%, 30%, 40%, or 50% Loss of Analgesic Response From Baseline During the Double-Blind Treatment Period | The percentage of lost analgesic response was defined as: (rolling seven day mean pain score during Double-Blind Period - Randomization Baseline pain intensity score) divided by Randomization Baseline pain intensity score times 100. If there was no event for a participant, time to the event was considered censored at Day 84 or before Day 84 at the time of the last diary pain score. The survival duration began on the date of first dose of study drug in the Double-Blind Period and was calculated as the [date of event or last diary pain score - date of first dose in Double-Blind Treatment +1]. | ITT Population; an event was defined as a participant with 20%, 30%, 40%, or 50% loss of analgesic response from Randomization Baseline. | Posted | | Median | 95% Confidence Interval | days | | Randomization Baseline, up to Week 12 | | | | ID | Title | Description |
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| OG000 | ALO-02 To Placebo | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks. | | OG001 |
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| Secondary | Percentage of Participants Discontinuing Treatment for Investigator-Reported Lack of Efficacy | If there was no event for a participant, time to the event was considered censored at Day 84 or before Day 84 at time of treatment discontinuation for another reason. | ITT Population; an event was defined as a participant with treatment discontinuation for investigator-reported lack of efficacy. | Posted | | Number | | Percentage of participants | | Week 1 up to Week 12 | | | | ID | Title | Description |
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| OG000 | ALO-02 To Placebo | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks. | | OG001 | ALO-02 To ALO-02 | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks. |
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| Secondary | Median Time to Treatment Discontinuation for Investigator-Reported Lack of Efficacy During the Double-Blind Treatment Period | If there was no event for a participant, time to the event was considered censored at Day 84 or before Day 84 at time of treatment discontinuation for another reason. The survival duration begins on the date of first dose in the Double-Blind period and is calculated as the [date of event or discontinuation - date of first dose in Double-Blind Period +1]. | ITT Population; an event was defined as a participant with treatment discontinuation for investigator-reported lack of efficacy. | Posted | | Median | 95% Confidence Interval | days | | Week 1 up to Week 12 | | | | ID | Title | Description |
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| OG000 | ALO-02 To Placebo | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks. | | OG001 | ALO-02 To ALO-02 | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks. |
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| Secondary | Clinical Opiate Withdrawal Scale (COWS) Total Score During the Open-Label Titration Period | The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant's signs or symptoms. The minimum total COWS score is 0, the maximum is 48. Higher scores indicate a worse outcome. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal. | Titration Period Safety Population. Only participants with values at both Screening and each respective visit were included in the change from screening analysis; n=number of participants analyzed for the given parameter at the specified timepoint. | Posted | | Mean | Standard Deviation | Units on a scale | | Screening, Weeks 1, 2, 3, 4, 5, and 6 | | | | ID | Title | Description |
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| OG000 | Open ALO-02 | Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. |
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| Secondary | COWS Total Score During the Double-Blind Treatment Period | The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant's signs or symptoms. The minimum total COWS score is 0, the maximum is 48. Higher scores indicate a worse outcome. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal. | Double-Blind Safety Population. Only participants with values at both Randomization Baseline and each respective visit were included in the change from Randomization Baseline analysis; n=number of participants analyzed for the given parameter at the specified timepoint. | Posted | | Mean | Standard Deviation | Units on a scale | | Randomization Baseline, Weeks 1, 2, 4, 8, and 12 | | | | ID | Title | Description |
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| OG000 | ALO-02 To Placebo | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks. | | OG001 | ALO-02 To ALO-02 | |
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| Secondary | COWS Total Score During the Post-Treatment Period | The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant's signs or symptoms. The minimum total COWS score is 0, the maximum is 48. Higher scores indicate a worse outcome. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal. | Double-Blind Safety Population. Only participants with values at both Randomization Baseline and each respective visit were included in the change from Randomization Baseline analysis; n=number of participants analyzed for the given parameter at the specified timepoint. | Posted | | Mean | Standard Deviation | Units on a scale | | Follow-Up (FU) Weeks 1 and 2 | | | | ID | Title | Description |
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| OG000 | ALO-02 To Placebo | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks. | | OG001 | ALO-02 To ALO-02 | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks. |
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| Secondary | Percentage of Participants With Opiate Withdrawal During the Open-Label Titration Period by COWS Category | The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant's signs or symptoms. The minimum total COWS score is 0, the maximum is 48. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal. The scores are assessed as follows: 5-12 = mild; 13-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal. | Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint. | Posted | | Number | | Percentage of participants | | Screening, Weeks 1, 2, 3, 4, 5, 6 (or Early Termination) | | | | ID | Title | Description |
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| OG000 | Open ALO-02 | Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. |
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| Secondary | Percentage of Participants With Opiate Withdrawal During the Double-Blind Treatment Period by COWS Category | The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant's signs or symptoms. The minimum total COWS score is 0, the maximum is 48. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal. The scores are assessed as follows: 5-12 = mild; 13-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal. | Double-Blind Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint. | Posted | | Number | | Percentage of participants | | Randomization Baseline, Weeks 1, 2, 4, 8, 12 (or Early Termination) | | | | ID | Title | Description |
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| OG000 | ALO-02 To Placebo | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks. | | OG001 | ALO-02 To ALO-02 | |
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| Secondary | Percentage of Participants With Opiate Withdrawal During Post-Treatment by COWS Category | The COWS contains 11 common opiate withdrawal signs or symptoms rated by the investigator or designee who, for each item, checked the number that best described the participant's signs or symptoms. The minimum total COWS score is 0, the maximum is 48. The summed score of the 11 items was used to assess a participant's level of opiate withdrawal. The scores are assessed as follows: 5-12 = mild; 13-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal. | Double-Blind Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint. | Posted | | Number | | Percentage of participants | | Follow-Up Weeks 1 and 2 | | | | ID | Title | Description |
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| OG000 | ALO-02 To Placebo | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks. | | OG001 | ALO-02 To ALO-02 | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks. |
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| Secondary | Subjective Opiate Withdrawal Scale (SOWS) During the Open-Label Titration Period | The SOWS was completed daily by the participant during any of the 2-week tapers from study drug, as well as at each study visit, using an eDiary device, and contains 16 symptoms of opiate withdrawal rated by the participant (Scale of 0 to 4: 0 = not at all, 1 = a little, 2= moderately, 3= quite a bit, 4 = extremely). The sum of the scores on each item was the total SOWS score; the minimum possible SOWS score was 0, the maximum 64. Higher scores indicate a worse outcome. | Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint. | Posted | | Mean | Standard Deviation | Units on a scale | | Screening, Weeks 1, 2, 3, 4, 5, and 6 | | | | ID | Title | Description |
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| OG000 | Open ALO-02 | Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. |
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| Secondary | SOWS Total Score During the Double-Blind Treatment Period | The SOWS was completed daily by the participant during any of the 2-week tapers from study drug, as well as at each study visit, using an eDiary device, and contains 16 symptoms of opiate withdrawal rated by the participant (Scale of 0 to 4: 0 = not at all, 1 = a little, 2= moderately, 3= quite a bit, 4 = extremely). The sum of the scores on each item was the total SOWS score; the minimum possible SOWS score was 0, the maximum 64. Higher scores indicate a worse outcome. | Double-Blind Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint. | Posted | | Mean | Standard Deviation | Units on a scale | | Randomization Baseline, Weeks 1, 2, 4, 8, and 12 | | | | ID | Title | Description |
|---|
| OG000 | ALO-02 To Placebo | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks. | | OG001 | ALO-02 To ALO-02 | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks. |
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| Secondary | SOWS Total Score During the Post-Treatment Period | The SOWS was completed daily by the participant during any of the 2-week tapers from study drug, as well as at each study visit, using an eDiary device, and contains 16 symptoms of opiate withdrawal rated by the participant (Scale of 0 to 4: 0 = not at all, 1 = a little, 2= moderately, 3= quite a bit, 4 = extremely). The sum of the scores on each item was the total SOWS score; the minimum possible SOWS score was 0, the maximum 64. Higher scores indicate a worse outcome. | Double-Blind Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint. | Posted | | Mean | Standard Deviation | Units on a scale | | Follow-Up Weeks 1 and 2 | | | | ID | Title | Description |
|---|
| OG000 | ALO-02 To Placebo | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks. | | OG001 | ALO-02 To ALO-02 | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks. |
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| Secondary | Change From Screening Period to End of Open-Label Titration Period in Roland-Morris Disability Questionnaire (RMDQ) Total Score for All Participants | RMDQ is a 24-item questionnaire designed to measure self-rated disability due to back pain the same day the questionnaire is completed. An individual participant's score could have ranged from 0 (no disability) to 24 (severe disability), with a lower score indicating better function; higher scores indicating greater disability. | Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint. | Posted | | Mean | Standard Deviation | Units on a scale | | Screening, Week 6 (or Early Termination) | | | | ID | Title | Description |
|---|
| OG000 | Open ALO-02 | Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. |
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| Secondary | Change From Screening Period to Randomization Baseline in RMDQ Total Score | RMDQ is a 24-item questionnaire designed to measure self-rated disability due to back pain the same day the questionnaire is completed. An individual participant's score could have ranged from 0 (no disability) to 24 (severe disability), with a lower score indicating better function. | ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint. | Posted | | Mean | Standard Deviation | Units on a scale | | Screening, Randomization Baseline | | | | ID | Title | Description |
|---|
| OG000 | Open ALO-02 | Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. |
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| Secondary | Change From Screening Period to End of Double-Blind Weeks 2, 4, 8, and 12 (or Final Visit) in RMDQ Total Score | RMDQ is a 24-item questionnaire designed to measure self-rated disability due to back pain the same day the questionnaire is completed. An individual participant's score could have ranged from 0 (no disability) to 24 (severe disability), with a lower score indicating better function. | ITT Population; imputation using the LOCF method for Week 12 only; Weeks 2, 4, 8 included observed cases. n=number of participants analyzed for the given parameter at the specified timepoint. | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Screening, Weeks 2, 4, 8, and 12 | | | | ID | Title | Description |
|---|
| OG000 | ALO-02 To Placebo | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks. | | OG001 | ALO-02 To ALO-02 | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks. |
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| Secondary | Change From Randomization Baseline to the End of Double-Blind Weeks 2, 4, and 8 in RMDQ Total Score | RMDQ is a 24-item questionnaire designed to measure self-rated disability due to back pain the same day the questionnaire is completed. An individual participant's score could have ranged from 0 (no disability) to 24 (severe disability), with a lower score indicating better function. | ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint. | Posted | | Least Squares Mean | Standard Error | Units on a scale | | Randomization Baseline, Weeks 2, 4, and 8 | | | | ID | Title | Description |
|---|
| OG000 | ALO-02 To Placebo | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks. | | OG001 | ALO-02 To ALO-02 | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks. |
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| Secondary | Percentage of Participants With Shift From Screening to Randomization Baseline in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor | Represents the score at Screening / score at Randomization Baseline in PGA of low back pain, a global evaluation that utilizes a 5-point Likert scale with a score of: 1 = very good, asymptomatic and no limitation of normal activities; 2 = good, mild symptoms, and no limitation of normal activities; 3 = fair, moderate symptoms and limitation to some normal activities; 4 = poor, severe symptoms and inability to carry out most normal activities; and a score of 5 = very poor; very severe symptoms, which were intolerable and inability to carry out all normal activities. | ITT Population; percentage was based on the number of participants who had non-missing values at Randomization Baseline and Screening. | Posted | | Number | | Percentage of participants | | Screening, Randomization Baseline | | | | ID | Title | Description |
|---|
| OG000 | Open ALO-02 | Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. |
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| Secondary | Percentage of Participants With Shift From Screening to the End of the Open-Label Titration Period in PGA of Low Back Pain by Category in Participants With Screening PGA Score of Very Good, Good, Fair, Poor, Very Poor | Represents the score at Screening / score at to end of the titration period in PGA of low back pain, a global evaluation that utilizes a 5-point Likert scale with a score of: 1 = very good, asymptomatic and no limitation of normal activities; 2 = good, mild symptoms, and no limitation of normal activities; 3 = fair, moderate symptoms and limitation to some normal activities; 4 = poor, severe symptoms and inability to carry out most normal activities; and a score of 5 = very poor; very severe symptoms, which were intolerable and inability to carry out all normal activities. | Titration Period Safety Population; percentage was based on the number of participants who had non-missing values at Randomization Baseline and Screening. | Posted | | Number | | Percentage of participants | | Screening, Randomization Baseline, or Early Termination | | | | ID | Title | Description |
|---|
| OG000 | Open ALO-02 | Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. |
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| Secondary | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 4 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good, Good, Fair, Poor, Very Poor | Represents the score at Randomization Baseline / score at Week 4 in PGA of low back pain, a global evaluation that utilizes a 5-point Likert scale with a score of: 1 = very good, asymptomatic and no limitation of normal activities; 2 = good, mild symptoms, and no limitation of normal activities; 3 = fair, moderate symptoms and limitation to some normal activities; 4 = poor, severe symptoms and inability to carry out most normal activities; and a score of 5 = very poor; very severe symptoms, which were intolerable and inability to carry out all normal activities. | ITT Population; percentage was based on the number of participants who had non-missing values at Randomization Baseline and Week 4 for each treatment. | Posted | | Number | | Percentage of participants | | Randomization Baseline, Week 4 | | | | ID | Title | Description |
|---|
| OG000 | ALO-02 To Placebo | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks. | |
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| Secondary | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Week 8 in PGA of Low Back Pain by Category in Participants With Randomization Baseline PGA Score of Very Good , Good, Fair, Poor, Very Poor | Represents the score at Randomization Baseline / score at Week 8 in PGA of low back pain, a global evaluation that utilizes a 5-point Likert scale with a score of: 1 = very good, asymptomatic and no limitation of normal activities; 2 = good, mild symptoms, and no limitation of normal activities; 3 = fair, moderate symptoms and limitation to some normal activities; 4 = poor, severe symptoms and inability to carry out most normal activities; and a score of 5 = very poor; very severe symptoms, which were intolerable and inability to carry out all normal activities. | ITT Population; percentage was based on the number of participants who had non-missing values at Randomization Baseline and Week 8 for each treatment. | Posted | | Number | | Percentage of participants | | Randomization Baseline, Week 8 | | | | ID | Title | Description |
|---|
| OG000 | ALO-02 To Placebo | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks. | |
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| Secondary | Satisfaction With Treatment at the End of Open-Label Titration Period for All Participants | Satisfaction with treatment is a single-item self-rated instrument that measures the participant's overall satisfaction with the study drug during study participation on a 5-point likert scale ranging from 1 = Very dissatisfied to 5 = Very satisfied. | Titration Period Safety Population; percentage was based on the number of participants with non-missing response to treatment. n=number of participants analyzed for the given parameter at the specified timepoint. | Posted | | Number | | Percentage of participants | | End of Open-Label Titration Period (Week 4, 5, or 6 or Early Termination) | | | | ID | Title | Description |
|---|
| OG000 | Open ALO-02 | Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. |
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| Secondary | Satisfaction With Treatment at Randomization Baseline | Satisfaction with treatment is a single-item self-rated instrument that measures the participant's overall satisfaction with the study drug during study participation on a 5-point likert scale ranging from 1 = Very dissatisfied to 5 = Very satisfied. | ITT Population; percentage was based on the number of participants with non-missing response to treatment. n=number of participants analyzed for the given parameter at the specified timepoint. | Posted | | Number | | Percentage of participants | | Randomization Baseline | | | | ID | Title | Description |
|---|
| OG000 | Open ALO-02 | Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. |
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| Secondary | Percentage of Participants Who Reported Being Satisfied/Very Satisfied With Treatment on the Satisfaction With Treatment Questionnaire During the Double-Blind Treatment Period | Participants used an electronic tablet at the center to rate their overall treatment satisfaction with study drug during study participation using a 5-point categorical scale (1 = very dissatisfied, 2 = dissatisfied, 3 = neither satisfied nor dissatisfied, 4 = satisfied, 5 = very satisfied). | ITT Population; percentage was based on the number of participants with non-missing response to treatment. n=number of participants analyzed for the given parameter at the specified timepoint. | Posted | | Number | | Percentage of participants | | Week 12 or Early Termination | | | | ID | Title | Description |
|---|
| OG000 | ALO-02 To Placebo | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks. | | OG001 | ALO-02 To ALO-02 | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks. |
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| Secondary | Change From Screening Period to the End of Open-Label Titration Period in Short Form-36v2 (SF-36v2) Health Survey Score | SF-36v2 Health Survey is a self-administered questionnaire consisting of 36 questions, measuring 8 health aspects; physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception. These domains also combine to form two component summary scores evaluating mental health and physical health. The minimum score is 0 and the maximum score is 100. A higher scores indicates a better health state. | Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint. | Posted | | Mean | Standard Deviation | Score on a scale | | Screening, Week 6 (or Early Termination) | | | | ID | Title | Description |
|---|
| OG000 | Open ALO-02 | Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. |
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| Secondary | Change From Screening Period to Randomization Baseline in SF-36v2 Health Survey Score | SF-36v2 Health Survey is a self-administered questionnaire consisting of 36 questions, measuring 8 health aspects; physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception. These domains also combine to form two component summary scores evaluating mental health and physical health. The minimum score is 0 and the maximum score is 100. A higher score indicate a better health state. | ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint. | Posted | | Mean | Standard Deviation | Score on a scale | | Screening, Randomization Baseline | | | | ID | Title | Description |
|---|
| OG000 | Open ALO-02 | Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. |
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| Secondary | Change From Randomization Baseline to the End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey | SF-36v2 Health Survey is a self-administered questionnaire consisting of 36 questions, measuring 8 health aspects; physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception. These domains also combine to form two component summary scores evaluating mental health and physical health. The minimum score is 0 and the maximum score is 100. A higher score indicate a better health state. | ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint. | Posted | | Least Squares Mean | Standard Error | Score on a scale | | Randomization Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | ALO-02 To Placebo | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks. | | OG001 | ALO-02 To ALO-02 |
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| Secondary | Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in SF-36v2 Health Survey | SF-36v2 Health Survey is a self-administered questionnaire consisting of 36 questions, measuring 8 health aspects; physical functioning, role limitations due to physical problems, social functioning, bodily pain, mental health, role limitations due to emotional problems, vitality, and general health perception. These domains also combine to form two component summary scores evaluating mental health and physical health. The minimum score is 0 and the maximum score is 100. A higher score indicate a better health state. | ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint. | Posted | | Least Squares Mean | Standard Error | Score on a scale | | Screening, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | ALO-02 To Placebo | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks. | | OG001 | ALO-02 To ALO-02 | |
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| Secondary | Change From Screening Period to the End of Open-Label Titration Period in Participant Assessment of Overall Health State Using the EuroQol 5-Dimensions (EQ-5D) Summary Index | The EQ 5D Health Questionnaire is a self completion standardized instrument for use as a measure of health-related quality of life in terms of a single index value or utility score that consisted of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which was rated on a 3-point response scale (no problems/some or moderate problems/extreme problems), and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health. | Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint. | Posted | | Mean | Standard Deviation | Score on a scale | | Screening, Week 6 (or Early Termination) | | | | ID | Title | Description |
|---|
| OG000 | Open ALO-02 | Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. |
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| Secondary | Change From Screening Period to the End of Open-Label Titration Period in Participant Assessment of Overall Health State Using the EQ-5D VAS | The EQ-5D consists of a standard vertical 20cm visual analogue scale (EQ VAS), for recording a participant's rating for their current health related quality of life state; the scale went from 0 (worst imaginable health state) to 100 (best imaginable health state). Participants were asked to draw a line on the scale to indicate how good or bad your own health is today, in your opinion. | Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint. | Posted | | Mean | Standard Deviation | Score on a scale | | Screening, Week 6 (or Early Termination) | | | | ID | Title | Description |
|---|
| OG000 | Open ALO-02 | Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. |
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| Secondary | Change From Screening Period to Randomization Baseline in Participant Assessment of Overall Health State Using the EQ-5D Summary Index | Self-completion standardized instrument for use as a measure of health-related quality of life in terms of a single index value or utility score that consisted of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which was rated on a 3-point response scale (no problems/some or moderate problems/extreme problems), and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health | ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint. | Posted | | Mean | Standard Deviation | Score on a scale | | Screening, Randomization Baseline | | | | ID | Title | Description |
|---|
| OG000 | Open ALO-02 | Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. |
| |
| Secondary | Change From Screening Period to Randomization Baseline in Participant Assessment of Overall Health State Using the EQ-5D VAS | The EQ-5D consists of a standard vertical 20cm visual analogue scale (EQ VAS), for recording a participant's rating for their current health related quality of life state; the scale went from 0 (worst imaginable health state) to 100 (best imaginable health state). Participants were asked to draw a line on the scale to indicate how good or bad your own health is today, in your opinion. | ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint. | Posted | | Mean | Standard Deviation | Score on a scale | | Screening, Randomization Baseline | | | | ID | Title | Description |
|---|
| OG000 | Open ALO-02 | Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. |
| |
| Secondary | Change From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using EQ-5D Summary Index | Self-completion standardized instrument for use as a measure of health-related quality of life in terms of a single index value or utility score that consisted of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which was rated on a 3-point response scale (no problems/some or moderate problems/extreme problems), and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health | ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint. | Posted | | Least Squares Mean | Standard Error | Score on a scale | | Randomization Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | ALO-02 To Placebo | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks. | | OG001 | ALO-02 To ALO-02 |
|
| Secondary | Change From Randomization Baseline to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using the EQ-5D VAS | The EQ-5D consists of a standard vertical 20cm visual analogue scale (EQ VAS), for recording a participant's rating for their current health related quality of life state; the scale went from 0 (worst imaginable health state) to 100 (best imaginable health state). Participants were asked to draw a line on the scale to indicate how good or bad your own health is today, in your opinion. | ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint. | Posted | | Least Squares Mean | Standard Error | Score on a scale | | Randomization Baseline, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | ALO-02 To Placebo | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks. | | OG001 | ALO-02 To ALO-02 | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks. |
|
| Secondary | Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using EQ-5D Summary Index | Self-completion standardized instrument for use as a measure of health-related quality of life in terms of a single index value or utility score that consisted of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which was rated on a 3-point response scale (no problems/some or moderate problems/extreme problems), and the scores are combined to form a single index utility value between 0 and 1 with higher scores indicating better health. | ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint. | Posted | | Least Squares Mean | Standard Error | Score on a scale | | Screening, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | ALO-02 To Placebo | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks. | | OG001 | ALO-02 To ALO-02 | |
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| Secondary | Change From Screening Period to End of Double-Blind Week 12 (or Final Visit) in Participant Assessment of Overall Health State Using EQ-5D VAS | The EQ-5D consists of a standard vertical 20cm visual analogue scale (EQ VAS), for recording a participant's rating for their current health related quality of life state; the scale went from 0 (worst imaginable health state) to 100 (best imaginable health state). Participants were asked to draw a line on the scale to indicate how good or bad your own health is today, in your opinion. | ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint. | Posted | | Least Squares Mean | Standard Error | Score on a scale | | Screening, Week 12 | | | | ID | Title | Description |
|---|
| OG000 | ALO-02 To Placebo | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks. | | OG001 | ALO-02 To ALO-02 | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks. |
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| Secondary | Change From Screening Period to End of Open-Label in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP): % Work Time Missed, % Impairment, % Overall Work Impairment, % Activity Impairment Due to Low Back Pain | A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment /absenteeism+presenteeism); and activity impairment.
- work time missed - a measure of absenteeism, calculated as work time missed due to health problem (question 2) as a proportion of hours actually worked (question 4).
- impairment while working - a measure of presenteeism, the degree to which health problem impacted work (question 5).
- overall work impairment - a measure of overall work productivity loss due to health problem (absenteeism+presenteeism).
- activity impairment - a measure of the degree to which health problem has affected ability to do regular activities other than work at a job (question 6). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity.
| Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint. | Posted | | Mean | Standard Deviation | Percentage | | Screening, Week 6 (or Early Termination) | | | | ID | Title | Description |
|---|
| OG000 | Open ALO-02 | Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. |
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| Secondary | Change From Screening Period to Randomization Baseline in WPAI:SHP: Percent Work Time Missed, Percent Impairment, Percent Overall Work Impairment, Percent Activity Impairment Due to Low Back Pain | A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment.
- work time missed - a measure of absenteeism, calculated as work time missed due to health problem (question 2) as a proportion of hours actually worked (question 4).
- impairment while working - a measure of presenteeism, the degree to which health problem impacted work (question 5).
- overall work impairment - a measure of overall work productivity loss due to health problem (absenteeism+presenteeism).
- activity impairment - a measure of the degree to which health problem has affected ability to do regular activities other than work at a job (question 6).
Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity. | ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint. | Posted | | Mean | Standard Deviation | Percentage | | Screening, Randomization Baseline | | | | ID | Title | Description |
|---|
| OG000 | Open ALO-02 | Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. |
| |
| Secondary | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Work Time Missed Due to Low Back Pain | A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment. % work time missed - a measure of absenteeism, calculated as work time missed due to health problem (question 2) as a proportion of hours actually worked (question 4). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity. | ITT Population; imputation by the LOCF method was used for Week 12 (or Final Visit) only; Weeks 4 and 8 were based on observed cases. n=number of participants analyzed for the given parameter at the specified timepoint. | Posted | | Least Squares Mean | Standard Error | Percentage | | Randomization Baseline, Weeks 4, 8, and 12 | | | | ID | Title | Description |
|---|
| OG000 | ALO-02 To Placebo | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks. |
|
| Secondary | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Impairment Due to Low Back Pain | A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment. % impairment while working - a measure of presenteeism, the degree to which health problem impacted work (question 5). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity. | ITT Population; imputation by the LOCF method was used for Week 12 (or Final Visit) only; Weeks 4 and 8 were based on observed cases. n=number of participants analyzed for the given parameter at the specified timepoint. | Posted | | Least Squares Mean | Standard Error | Percentage | | Randomization Baseline, Weeks 4, 8, and 12 | | | | ID | Title | Description |
|---|
| OG000 | ALO-02 To Placebo | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks. | |
|
| Secondary | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Overall Work Impairment Due to Low Back Pain | A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment. % overall work impairment - a measure of overall work productivity loss due to health problem (absenteeism+presenteeism). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity. | ITT Population; imputation by the LOCF method was used for Week 12 (or Final Visit) only; Weeks 4 and 8 were based on observed cases. n=number of participants analyzed for the given parameter at the specified timepoint. | Posted | | Least Squares Mean | Standard Error | Percentage | | Randomization Baseline, Weeks 4, 8, and 12 | | | | ID | Title | Description |
|---|
| OG000 | ALO-02 To Placebo | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks. | |
|
| Secondary | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Activity Impairment Due to Low Back Pain | A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment. % activity impairment - a measure of the degree to which health problem has affected ability to do regular activities other than work at a job (question 6). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity. | ITT Population; imputation by the LOCF method was used for Week 12 (or Final Visit) only; Weeks 4 and 8 were based on observed cases. n=number of participants analyzed for the given parameter at the specified timepoint. | Posted | | Least Squares Mean | Standard Error | Percentage | | Randomization Baseline, Weeks 4, 8, and 12 | | | | ID | Title | Description |
|---|
| OG000 | ALO-02 To Placebo | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks. |
|
| Secondary | Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Work Time Missed Due to Low Back Pain | A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment. % work time missed - a measure of absenteeism, calculated as work time missed due to health problem (question 2) as a proportion of hours actually worked (question 4). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity. | ITT Population; imputation by the LOCF method was used for Week 12 (or Final Visit) only; Weeks 4 and 8 were based on observed cases. n=number of participants analyzed for the given parameter at the specified timepoint. | Posted | | Least Squares Mean | Standard Error | Percentage | | Screening, Weeks 4, 8, and 12 | | | | ID | Title | Description |
|---|
| OG000 | ALO-02 To Placebo | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks. | |
|
| Secondary | Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Impairment Due to Low Back Pain | A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment. % impairment while working - a measure of presenteeism, the degree to which health problem impacted work (question 5). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity. | ITT Population; imputation by the LOCF method was used for Week 12 (or Final Visit) only; Weeks 4 and 8 were based on observed cases. n=number of participants analyzed for the given parameter at the specified timepoint. | Posted | | Least Squares Mean | Standard Error | Percentage | | Screening, Weeks 4, 8, and 12 | | | | ID | Title | Description |
|---|
| OG000 | ALO-02 To Placebo | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks. | | OG001 |
|
| Secondary | Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Overall Work Impairment Due to Low Back Pain | A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment. % overall work impairment - a measure of overall work productivity loss due to health problem (absenteeism+presenteeism). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity. | ITT Population; imputation by the LOCF method was used for Week 12 (or Final Visit) only; Weeks 4 and 8 were based on observed cases. n=number of participants analyzed for the given parameter at the specified timepoint. | Posted | | Least Squares Mean | Standard Error | Percentage | | Screening, Weeks 4, 8, and 12 | | | | ID | Title | Description |
|---|
| OG000 | ALO-02 To Placebo | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks. | | OG001 |
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| Secondary | Change From Screening Period to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in WPAI:SHP Percent Activity Impairment Due to Low Back Pain | A self-reported measure of work productivity and impairment that yields 4 scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on the job effectiveness); work productivity loss (overall work impairment/absenteeism+presenteeism); and activity impairment. % activity impairment - a measure of the degree to which health problem has affected ability to do regular activities other than work at a job (question 6). Each score is expressed as a percentage (0-100%) with higher numbers indicating greater impairment and less productivity. | ITT Population; imputation by the LOCF method was used for Week 12 (or Final Visit) only; Weeks 4 and 8 were based on observed cases. n=number of participants analyzed for the given parameter at the specified timepoint. | Posted | | Least Squares Mean | Standard Error | Percentage | | Screening, Weeks 4, 8, and 12 | | | | ID | Title | Description |
|---|
| OG000 | ALO-02 To Placebo | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks. | |
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| Secondary | Percentage of Participants With Shift From Screening Period to End of Open-Label Titration Period in Hospitalization Because of Low Back Pain as Assessed Using the Healthcare Resource Use (HRU) Questionnaire | Question 3a = In the past 4 weeks, have you been hospitalized due to chronic low back pain or any medication used for chronic low back pain? | Titration Period Safety Population; the denominator for the percentage calculation is the number of participants who had both Screening value and End of Open-Label value. | Posted | | Number | | Percentage of participants | | Screening, Week 6 (or Early Termination) | | | | ID | Title | Description |
|---|
| OG000 | Open ALO-02 | Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. |
| |
| Secondary | Percentage of Participants With Shift From Screening Period to Randomization Baseline in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire | Question 3a = In the past 4 weeks, have you been hospitalized due to chronic low back pain or any medication used for chronic low back pain? | ITT Population; the denominator for the percentage calculation is the number of participants who had both Screening value and Randomization Baseline value. | Posted | | Number | | Percentage of participants | | Screening, Randomization Baseline | | | | ID | Title | Description |
|---|
| OG000 | Open ALO-02 | Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. |
| |
| Secondary | Change From Screening to Randomization Baseline in HRU Questionnaire: Number of Office Visits Directly Related or Any Medication Used for Chronic Low Back Pain | Question 1: number of office visits directly related to chronic low back pain or any medication used for chronic low back pain. | ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint. | Posted | | Mean | Standard Deviation | Number of visits | | Screening, Randomization Baseline | | | | ID | Title | Description |
|---|
| OG000 | Open ALO-02 | Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. |
| |
| Secondary | Change From Screening to Randomization Baseline in HRU Questionnaire: Money Spent on Physical Treatments in Past 4 Weeks | Question 2: Money (dollars) spent out-of-pocket on physical treatments in the past 4 weeks to manage chronic low back pain | ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint. | Posted | | Mean | Standard Deviation | Dollars | | Screening, Randomization Baseline | | | | ID | Title | Description |
|---|
| OG000 | Open ALO-02 | Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. |
| |
| Secondary | Change From Screening to Randomization Baseline in HRU Questionnaire: Nights Stayed in Hospital | Question 3b: nights stayed in the hospital, if answer to Q3a was yes. | ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint. | Posted | | Mean | Standard Deviation | Number of days | | Screening, Randomization Baseline | | | | ID | Title | Description |
|---|
| OG000 | Open ALO-02 | Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. |
| |
| Secondary | Change From Screening to End of Open-Label Titration Period in HRU Questionnaire: Number of Office Visits Directly Related or Any Medication Used for Chronic Low Back Pain | Question 1: number of office visits directly related to chronic low back pain or any medication used for chronic low back pain. | Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint. | Posted | | Mean | Standard Deviation | Number of visits | | Screening, Week 6 (or Early Termination) | | | | ID | Title | Description |
|---|
| OG000 | Open ALO-02 | Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. |
| |
| Secondary | Change From Screening to End of Open-Label Titration Period in HRU Questionnaire: Money Spent on Physical Treatments in Past 4 Weeks | Question 2: Money (dollars) spent out-of-pocket on physical treatments in the past 4 weeks to manage chronic low back pain | Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint. | Posted | | Mean | Standard Deviation | Dollars | | Screening, Week 6 (or Early Termination) | | | | ID | Title | Description |
|---|
| OG000 | Open ALO-02 | Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. |
| |
| Secondary | Change From Screening to End of Open-Label Titration Period in HRU Questionnaire: Nights Stayed in Hospital | Question 3b: nights stayed in the hospital, if answer to Q3a was yes. | Titration Period Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint. | Posted | | Mean | Standard Deviation | Number of days | | Screening, Week 6 (or Early Termination) | | | | ID | Title | Description |
|---|
| OG000 | Open ALO-02 | Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. |
| |
| Secondary | Percentage of Participants With Shift From Randomization Baseline to End of Double-Blind Weeks 4, 8, and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire | Question 3a = In the past 4 weeks, have you been hospitalized due to chronic low back pain or any medication used for chronic low back pain? | ITT Population; the denominator for the percentage calculation is the number of participants who had both Randomization Baseline value and Post Randomization value for each treatment and visit. Imputation using the LOCF method. | Posted | | Number | | Percentage of participants | | Randomization Baseline, Weeks 4, 8, and 12 (or Early Termination) | | | | ID | Title | Description |
|---|
| OG000 | ALO-02 To Placebo | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks. | | OG001 | ALO-02 To ALO-02 | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks. |
|
| Secondary | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related to or Medications Used for Chronic Low Back Pain | Question 1: number of office visits directly related to chronic low back pain or any medication used for chronic low back pain | ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint. | Posted | | Mean | Standard Deviation | Number of visits | | Randomization Baseline, Weeks 4, 8, and 12 | | | | ID | Title | Description |
|---|
| OG000 | ALO-02 To Placebo | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks. | | OG001 | ALO-02 To ALO-02 | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks. |
|
| Secondary | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatments | Question 2: money (dollars) spent out-of-pocket on physical treatments in the past 4 weeks to manage chronic low back pain. | ITT Population, imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint. | Posted | | Mean | Standard Deviation | Dollars | | Randomization Baseline, Weeks 4, 8, and 12 | | | | ID | Title | Description |
|---|
| OG000 | ALO-02 To Placebo | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks. | | OG001 | ALO-02 To ALO-02 | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks. |
|
| Secondary | Change From Randomization Baseline to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights Spent in Hospital | Question 3b: nights stayed in the hospital | ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint. | Posted | | Mean | Standard Deviation | Number of nights | | Randomization Baseline, Weeks 4, 8, and 12 | | | | ID | Title | Description |
|---|
| OG000 | ALO-02 To Placebo | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks. | | OG001 | ALO-02 To ALO-02 | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks. |
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| Secondary | Percentage of Participants With Shift From Screening Period to the End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in Hospitalization Because of Low Back Pain as Assessed Using the HRU Questionnaire | Question 3a = In the past 4 weeks, have you been hospitalized due to chronic low back pain or any medication used for chronic low back pain? | ITT Population; the denominator for the percentage calculation is the number of participants who had both Screening value and Post Screening value for each treatment and visit. Imputation using the LOCF method. | Posted | | Number | | Percentage of participants | | Screening, Weeks 4, 8, and 12 | | | | ID | Title | Description |
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| OG000 | ALO-02 To Placebo | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks. | | OG001 | ALO-02 To ALO-02 | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks. |
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| Secondary | Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Number of Office Visits Related or Medication Used for Chronic Low Back Pain | Question 1: number of office visits directly related to chronic low back pain or any medication used for chronic low back pain | ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint. | Posted | | Mean | Standard Deviation | Number of visits | | Screening, Weeks 4, 8, and 12 | | | | ID | Title | Description |
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| OG000 | ALO-02 To Placebo | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks. | | OG001 | ALO-02 To ALO-02 | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks. |
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| Secondary | Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Money Spent on Treatment for Chronic Low Back Pain | Question 2: money (dollars) spent out-of-pocket on physical treatments in the past 4 weeks to manage chronic low back pain | ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint. | Posted | | Mean | Standard Deviation | Dollars | | Screening, Weeks 4, 8, and 12 | | | | ID | Title | Description |
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| OG000 | ALO-02 To Placebo | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks. | | OG001 | ALO-02 To ALO-02 | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks. |
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| Secondary | Change From Screening Period to End of Double-Blind Weeks 4, 8 and 12 (or Final Visit) in HRU Questionnaire: Nights in Hospital for Chronic Low Back Pain | Question 3b: nights stayed in the hospital | ITT Population; imputation using the LOCF method. n=number of participants analyzed for the given parameter at the specified timepoint. | Posted | | Mean | Standard Deviation | Number of nights | | Screening, Weeks 4, 8, and 12 | | | | ID | Title | Description |
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| OG000 | ALO-02 To Placebo | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks. | | OG001 | ALO-02 To ALO-02 | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks. |
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| Secondary | Mean Oxycodone Average Daily Dose During the Open-Label Titration Period | | Titration Period Safety Population | Posted | | Mean | Standard Deviation | mg | | Open-Label Period | | | | ID | Title | Description |
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| OG000 | Open ALO-02 | Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. |
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| Secondary | Mean Oxycodone Duration of Titration During the Open-Label Titration Period | | Titration Period Safety Population | Posted | | Mean | Standard Deviation | days | | Open-Label Period | | | | ID | Title | Description |
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| OG000 | Open ALO-02 | Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. |
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| Secondary | Median Oxycodone Average Daily Dose During the Open-Label Titration Period | | Titration Period Safety Population | Posted | | Median | Inter-Quartile Range | mg | | Open-Label Period | | | | ID | Title | Description |
|---|
| OG000 | Open ALO-02 | Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. |
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| Secondary | Median Oxycodone Duration of Titration During the Open-Label Titration Period | | Titration Period Safety Population | Posted | | Median | Inter-Quartile Range | days | | Open-Label Period | | | | ID | Title | Description |
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| OG000 | Open ALO-02 | Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. |
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| Secondary | Mean Oxycodone Average Daily Dose During the Double-Blind Treatment Period | | Double-Blind Safety Population | Posted | | Mean | Standard Deviation | mg | | Double-Blind Period | | | | ID | Title | Description |
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| OG000 | ALO-02 To Placebo | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks. | | OG001 | ALO-02 To ALO-02 | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks. |
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| Secondary | Mean Oxycodone Duration of Treatment During the Double-Blind Treatment Period | | Double-Blind Safety Population | Posted | | Mean | Standard Deviation | days | | Double-Blind Period | | | | ID | Title | Description |
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| OG000 | ALO-02 To Placebo | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks. | | OG001 | ALO-02 To ALO-02 | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks. |
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| Secondary | Median Oxycodone Average Daily Dose During the Double-Blind Treatment Period | | Double-Blind Safety Population | Posted | | Median | Inter-Quartile Range | mg | | Double-Blind Period | | | | ID | Title | Description |
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| OG000 | ALO-02 To Placebo | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks. | | OG001 | ALO-02 To ALO-02 | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks. |
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| Secondary | Median Oxycodone Duration of Treatment During the Double-Blind Treatment Period | | Double-Blind Safety Population | Posted | | Median | Inter-Quartile Range | days | | Double-Blind Period | | | | ID | Title | Description |
|---|
| OG000 | ALO-02 To Placebo | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks. | | OG001 | ALO-02 To ALO-02 | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks. |
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| Secondary | Oxycodone and Noroxycodone Observed Steady-State Plasma Concentration During the Titration Period | Observed steady-state plasma concentration (Cobs) of oxycodone and noroxycodone. | Titration Period Safety Population; participants assessed at Week 6 had not been randomized to the Double-Blind Period; participants assessed at Randomization Baseline had been randomized to the Double-Blind Period. | Posted | | Mean | Standard Deviation | ng/mL | | Blood samples were taken within +/-4 hours of the morning dose of ALO-02 at Week 6/Early Termination, Randomization Baseline | | | | ID | Title | Description |
|---|
| OG000 | Open ALO-02 | Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. |
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| Secondary | Naltrexone and 6-β-naltrexol Observed Steady-State Plasma Concentration During the Titration Period | Cobs of naltrexone and 6-β-naltrexol | Titration Period Safety Population; participants assessed at Week 6 had not been randomized to the Double-Blind Period; participants assessed at Randomization Baseline had been randomized to the Double-Blind Period. | Posted | | Mean | Standard Deviation | pg/mL | | Blood samples were taken within +/-4 hours of the morning dose of ALO-02 at Week 6/Early Termination, Randomization Baseline | | | | ID | Title | Description |
|---|
| OG000 | Open ALO-02 | Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. |
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| Secondary | Oxycodone and Noroxycodone Observed Steady-State Plasma Concentration During the Double-Blind Treatment Period | Observed steady-state plasma concentration (Cobs) of oxycodone and noroxycodone | Double-Blind Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint. | Posted | | Mean | Standard Deviation | ng/mL | | Blood samples were taken within +/-4 hours of the morning dose of study drug at Randomization Baseline, Weeks 4, 8, and 12 | | | | ID | Title | Description |
|---|
| OG000 | ALO-02 To Placebo | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks. | | OG001 | ALO-02 To ALO-02 | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks. |
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| Secondary | Naltrexone and 6-β-naltrexol Observed Steady-State Plasma Concentration During the Double Blind Treatment Period | Observed steady-state plasma concentration (Cobs) of naltrexone and 6-β-naltrexol | Double-Blind Safety Population; n=number of participants analyzed for the given parameter at the specified timepoint. | Posted | | Mean | Standard Deviation | pg/mL | | Blood samples were taken within +/-4 hours of the morning dose of study drug at Randomization Baseline, Weeks 4, 8, and 12 | | | | ID | Title | Description |
|---|
| OG000 | ALO-02 To Placebo | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks. | | OG001 | ALO-02 To ALO-02 | Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks. |
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