| Primary | Sum of Pain Intensity Difference (SPID) for Low Back Pain - Summary Statistics at 120 Hours (With Imputation) | Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 120 hours. | Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS). | Posted | Jul 2011 | Least Squares Mean | Standard Error | Units on a scale | | 0 hour (prior to first dose) and 120 hours | | | | ID | Title | Description |
|---|
| OG000 | NUCYNTA | 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg | | OG001 | Oxycodone IR | 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000264.6± 11.43
- OG001264.0± 11.22
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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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| | ANCOVA | | 0.9703 | | Mean Difference (Final Values) | -0.6 | Standard Error of the Mean | 16.02 | 2-Sided | 95 | -32.1 | 30.9 | | | | Yes | Non-Inferiority or Equivalence | The sample size was recalculated due to Amendment INT-1. The non-inferiority margin for SPID120 was set as 120. The common standard deviation for the SPID120 data was estimated to be 230. Seventy nine subjects in each arm would have 90% power to demonstrate the non-inferiority of NUCYNTA to oxycodone IR with a 1-sided significance level of 0.025. This would have required enrollment of total 158 mITT subjects for each stratum. The original sample size (292 mITT subjects) was derived for SPID72. |
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| Secondary | Sum of Pain Intensity Difference (SPID) for Low Back Pain - Summary Statistics at 2 Days (With Imputation) | Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 2 days. | Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS). | Posted | Jul 2011 | Least Squares Mean | Standard Error | Units on a Scale | | Day 0 and Day 2 | | | | ID | Title | Description |
|---|
| OG000 | NUCYNTA | 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg | | OG001 | Oxycodone IR | 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg |
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| Secondary | SPID for Low Back Pain - Summary Statistics at 3 Days (With Imputation) | Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 3 days. | Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS). | Posted | Jul 2011 | Least Squares Mean | Standard Error | Units on a scale | | Day 0 and Day 3 | | | | ID | Title | Description |
|---|
| OG000 | NUCYNTA | 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg | | OG001 | Oxycodone IR | 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg |
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| Secondary | SPID for Low Back Pain - Summary Statistics at 10 Days (With Imputation) | Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 10 days. | Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS). | Posted | Jul 2011 | Least Squares Mean | Standard Error | Units on a scale | | Day 0 and Day 10 | | | | ID | Title | Description |
|---|
| OG000 | NUCYNTA | 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg | | OG001 | Oxycodone IR | 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg |
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| Secondary | SPID for Index Leg Pain - Summary Statistics at 2 Days (With Imputation) | Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 2 days. | Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS). | Posted | Jul 2011 | Least Squares Mean | Standard Error | Units on a Scale | | Day 0 and Day 2 | | | | ID | Title | Description |
|---|
| OG000 | NUCYNTA | 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg | | OG001 | Oxycodone IR | 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg |
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| Secondary | SPID for Index Leg Pain - Summary Statistics at 3 Days (With Imputation) | Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 3 days. | Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS). | Posted | Jul 2011 | Least Squares Mean | Standard Error | Units on a Scale | | Day 0 and Day 3 | | | | ID | Title | Description |
|---|
| OG000 | NUCYNTA | 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg | | OG001 | Oxycodone IR | 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg |
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| Secondary | SPID for Index Leg Pain - Summary Statistics at 5 Days (With Imputation) | Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 5 days. | Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS). | Posted | Jul 2011 | Least Squares Mean | Standard Error | Units on a Scale | | Day 0 and Day 5 | | | | ID | Title | Description |
|---|
| OG000 | NUCYNTA | 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg | | OG001 | Oxycodone IR | 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg |
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| Secondary | SPID for Index Leg Pain - Summary Statistics at 10 Days (With Imputation) | Pain intensity is an 11-point numerical rating scale (NRS). 0=no pain, 10=Pain as bad as you can imagine. The pain intensity difference (PID) was to be calculated as baseline pain minus current pain at each assessment time point. SPID is a weighted sum of PID over a specified time period, say 10 days. | Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS). | Posted | Jul 2011 | Least Squares Mean | Standard Error | Units on a Scale | | Day 0 and Day 10 | | | | ID | Title | Description |
|---|
| OG000 | NUCYNTA | 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg | | OG001 | Oxycodone IR | 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg |
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| Secondary | Total Pain Relief (TOTPAR) for Low Back Pain - Summary Statistics at 5 Days | Pain Relief - 5-Point Numerical Rating Scale, 0=None, 4=Complete. Total Pain Relief (TOTPAR) is a weighted sum of pain relieve over a specified time period, say 5 days. | Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS). | Posted | Jul 2011 | Least Squares Mean | Standard Error | Units on a Scale | | Day 0 and Day 5 | | | | ID | Title | Description |
|---|
| OG000 | NUCYNTA | 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg | | OG001 | Oxycodone IR | 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg |
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| Secondary | SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Continuous Pain Day 5 | Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Continuous pain subscale descriptors include: throbbing pain, cramping pain, gnawing pain, aching pain, heavy pain, and tender. | Intent-To-Treat Population (all randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain) and have both baseline and Day 5 SF-MPQ-2 measurement | Posted | Jul 2011 | Mean | Standard Deviation | Units on a Scale | | Day 0 and Day 5 | | | | ID | Title | Description |
|---|
| OG000 | NUCYNTA | 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg | | OG001 | Oxycodone IR | 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg |
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| Secondary | SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Continuous Pain Day 10/Last Visit | Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Continuous pain subscale descriptors include: throbbing pain, cramping pain, gnawing pain, aching pain, heavy pain, and tender. | Intent-To-Treat Population and have both baseline and Day 10 SF-MPQ-2 measurements. | Posted | Jul 2011 | Mean | Standard Deviation | Units on a Scale | | Day 0 and Day 10 | | | | ID | Title | Description |
|---|
| OG000 | NUCYNTA | 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg | | OG001 | Oxycodone IR | 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg |
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| Secondary | SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Intermittent Pain Day 5 | Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Intermittent pain subscale descriptors include: shooting pain, stabbing pain, sharp pain, splitting pain, electric-shock pain, and piercing. | Intent-To-Treat Population and have both baseline and Day 5 SF-MPQ-2 measurements. | Posted | Jul 2011 | Mean | Standard Deviation | Units on a Scale | | Day 0 and Day 5 | | | | ID | Title | Description |
|---|
| OG000 | NUCYNTA | 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg | | OG001 | Oxycodone IR | 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg |
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| Secondary | SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Intermittent Pain Day 10/Last Visit | Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Intermittent pain subscale descriptors include: shooting pain, stabbing pain, sharp pain, splitting pain, electric-shock pain, and piercing. | Intent-To-Treat Population and have both baseline and Day 10 SF-MPQ-2 measurements. | Posted | Jul 2011 | Mean | Standard Deviation | Units on a Scale | | Day 0 and Day 10 | | | | ID | Title | Description |
|---|
| OG000 | NUCYNTA | 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg | | OG001 | Oxycodone IR | 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg |
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| Secondary | SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Neuropathic Pain Day 5 | Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Predominantly neuropathic pain subscale descriptors include: hot-burning pain, cold-freezing pain, pain caused by light touch, itching, tingling or "pins and needles" and numbness. | Intent-To-Treat Population and have both baseline and Day 5 SF-MPQ-2 measurements. | Posted | Jul 2011 | Mean | Standard Deviation | Units on a Scale | | Day 0 and Day 5 | | | | ID | Title | Description |
|---|
| OG000 | NUCYNTA | 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg | | OG001 | Oxycodone IR | 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg |
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| Secondary | SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Neuropathic Pain Day 10/Last Visit | Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Predominantly neuropathic pain subscale descriptors include: hot-burning pain, cold-freezing pain, pain caused by light touch, itching, tingling or "pins and needles" and numbness. | Intent-To-Treat Population and have both baseline and Day 10 SF-MPQ-2 measurements. | Posted | Jul 2011 | Mean | Standard Deviation | Units on a Scale | | Day 0 and Day 10 | | | | ID | Title | Description |
|---|
| OG000 | NUCYNTA | 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg | | OG001 | Oxycodone IR | 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg |
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| Secondary | SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Affective Descriptors Day 5 | Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Affective subscale descriptors include: tiring-exhausting, sickening, fearful, and punishing-cruel. | Intent-To-Treat Population and have both baseline and Day 5 SF-MPQ-2 measurements. | Posted | Jul 2011 | Mean | Standard Deviation | score of scale | | Day 0 and Day 5 | | | | ID | Title | Description |
|---|
| OG000 | NUCYNTA | 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg | | OG001 | Oxycodone IR | 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg |
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| Secondary | SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Affective Descriptors Day 10/Last Visit | Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). Subscale scores are calculated as the mean of the items in that subscale ranged from 0 to 10. Affective subscale descriptors include: tiring-exhausting, sickening, fearful, and punishing-cruel. | Intent-To-Treat Population and have both baseline and Day 10 SF-MPQ-2 measurements. | Posted | Jul 2011 | Mean | Standard Deviation | Units on a Scale | | Day 0 and Day 10 | | | | ID | Title | Description |
|---|
| OG000 | NUCYNTA | 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg | | OG001 | Oxycodone IR | 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg |
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| Secondary | SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Total Score Day 5 | Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). The total SF-MPQ-2 scale score is calculated as the mean of all 22 items. The range of the total score is 0 to 10. | Intent-To-Treat Population and have both baseline and Day 5 SF-MPQ-2 measurements. | Posted | Jul 2011 | Mean | Standard Deviation | Units on a Scale | | Day 0 and Day 5 | | | | ID | Title | Description |
|---|
| OG000 | NUCYNTA | 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg | | OG001 | Oxycodone IR | 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg |
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| Secondary | SF-MPQ-2 - Change From Baseline Values: Subscale and Total Scores - Total Score Day 10/Last Visit | Short-Form McGill Pain Questionnaire - 2 (SF-MPQ-2) is a 22-question instrument. Each item lists different qualities of pain or related symptoms and is scored using an 11-point NRS ranging from (pain or symptom is not present) to 10 (worst possible pain). The total SF-MPQ-2 scale score is calculated as the mean of all 22 items. The range of the total score is 0 to 10. | Intent-To-Treat Population with both baseline and Day 10 SF-MPQ-2 measurements. | Posted | Jul 2011 | Mean | Standard Deviation | Units on a Scale | | Day 0 and Day 10 | | | | ID | Title | Description |
|---|
| OG000 | NUCYNTA | 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg | | OG001 | Oxycodone IR | 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg |
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| Secondary | Patient Global Impression of Change at End of Study | Patient Global Impression of Change (PGIC) assesses the subject's global improvement since starting study treatment using a 7-point NRS (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse). | Intent-To-Treat Population. | Posted | Jul 2011 | Number | | Units on a Scale | | Day 0 and Day 10/last visit | | | | ID | Title | Description |
|---|
| OG000 | NUCYNTA | 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg | | OG001 | Oxycodone IR | 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg |
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| Secondary | Patient Global Impression of Change at End of Study | Patient Global Impression of Change (PGIC) assesses the subject's global improvement since starting study treatment using a 7-point NRS (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse). | Intent-To-Treat Population with PGIC assessment. | Posted | Jul 2011 | Mean | Standard Deviation | Units on a Scale | | Day 0 and Day 10/lst visit | | | | ID | Title | Description |
|---|
| OG000 | NUCYNTA | 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg | | OG001 | Oxycodone IR | 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg |
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| Secondary | Clinician Global Impression of Change at End of Study | Clinician Global Impression of Change (CGIC) assesses the subject's global improvement since starting study treatment using a 7-point NRS (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse). | Intent-To-Treat Population. | Posted | Jul 2011 | Number | | Units on a Scale | | Day 0 and Day 10/last visit | | | | ID | Title | Description |
|---|
| OG000 | NUCYNTA | 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg | | OG001 | Oxycodone IR | 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg |
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| Secondary | Clinician Global Impression of Change at End of Study | Clinician Global Impression of Change (CGIC) assesses the subject's global improvement since starting study treatment using a 7-point NRS (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse). | Intent-To-Treat Population with CGIC assessment. | Posted | Jul 2011 | Mean | Standard Deviation | Units on a Scale | | Day 0 and Day 10/last visit | | | | ID | Title | Description |
|---|
| OG000 | NUCYNTA | 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg | | OG001 | Oxycodone IR | 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg |
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| Secondary | Satisfaction With Treatment at Day 5 | The subject's satisfaction with treatment was assessed using a 7-point scale (1=Very satisfied, 2=Somewhat satisfied, 3=Slightly satisfied, 4=Neither satisfied nor dissatisfied, 5=Slightly dissatisfied, 6=Somewhat dissatisfied, 7=Very dissatisfied). | Intent-To-Treat Population. | Posted | Jul 2011 | Number | | Units on a Scale | | Day 0 and Day 5 | | | | ID | Title | Description |
|---|
| OG000 | NUCYNTA | 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg | | OG001 | Oxycodone IR | 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg |
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| Secondary | Satisfaction With Treatment at Day 5 | The subject's satisfaction with treatment was assessed using a 7-point scale (1=Very satisfied, 2=Somewhat satisfied, 3=Slightly satisfied, 4=Neither satisfied nor dissatisfied, 5=Slightly dissatisfied, 6=Somewhat dissatisfied, 7=Very dissatisfied). | Intent-To-Treat Population with subject's satisfaction assessment on Day 5. | Posted | Jul 2011 | Mean | Standard Deviation | Units on a Scale | | Day 0 and Day 5 | | | | ID | Title | Description |
|---|
| OG000 | NUCYNTA | 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg | | OG001 | Oxycodone IR | 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg |
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| Secondary | Satisfaction With Treatment at End of Study | The subject's satisfaction with treatment was assessed using a 7-point scale (1=Very satisfied, 2=Somewhat satisfied, 3=Slightly satisfied, 4=Neither satisfied nor dissatisfied, 5=Slightly dissatisfied, 6=Somewhat dissatisfied, 7=Very dissatisfied). | Intent-To-Treat Population. | Posted | Jul 2011 | Number | | Units on a Scale | | Day 0 and Day 10/last visit | | | | ID | Title | Description |
|---|
| OG000 | NUCYNTA | 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg | | OG001 | Oxycodone IR | 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg |
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| Secondary | Satisfaction With Treatment at End of Study | The subject's satisfaction with treatment was assessed using a 7-point scale (1=Very satisfied, 2=Somewhat satisfied, 3=Slightly satisfied, 4=Neither satisfied nor dissatisfied, 5=Slightly dissatisfied, 6=Somewhat dissatisfied, 7=Very dissatisfied). | Intent-To-Treat Population with subject's satisfaction assessment at end of the study. | Posted | Jul 2011 | Mean | Standard Deviation | Units on a Scale | | Day 0 and Day 10/last visit | | | | ID | Title | Description |
|---|
| OG000 | NUCYNTA | 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg | | OG001 | Oxycodone IR | 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg |
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| Secondary | Incidence of 30% Responders Without Nausea or Vomiting at Day 5 | Number of subjects had ≥ 30% reduction from baseline in low back pain intensity without nausea or vomiting reported. | Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS). | Posted | Jul 2011 | Number | | Participants | | Day 0 and Day 5 | | | | ID | Title | Description |
|---|
| OG000 | NUCYNTA | 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg | | OG001 | Oxycodone IR | 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg |
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| Secondary | Incidence of 50% Responders Without Nausea or Vomiting at Day 5 | Number of subjects had ≥ 50% reduction from baseline in low back pain intensity without nausea or vomiting reported. | Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS). | Posted | Jul 2011 | Number | | Participants | | Day 0 and Day 5 | | | | ID | Title | Description |
|---|
| OG000 | NUCYNTA | 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg | | OG001 | Oxycodone IR | 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg |
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| Secondary | Summary of Treatment-Emergent Adverse Events Leading to Study Drug Discontinuation | | Safety Population: all randomized subjects who take at least 1 dose of study drug. | Posted | Jul 2011 | Number | | Participants | | Day 0 and Day 10/last visit | | | | ID | Title | Description |
|---|
| OG000 | NUCYNTA | 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg | | OG001 | Oxycodone IR | 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg |
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| Secondary | Summary of Subjects Having Nausea as a Treatment-Emergent Adverse Event | Number of subjects that reported nausea as a treatment-emergent adverse event during the study. | Safety Population: all randomized subjects who take at least 1 dose of study drug. | Posted | Jul 2011 | Number | | Participants | | Day 0 and Day 10/last visit | | | | ID | Title | Description |
|---|
| OG000 | NUCYNTA | 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg | | OG001 | Oxycodone IR | 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg |
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| Secondary | Summary of Subjects Having Vomiting as a Treatment-Emergent Adverse Event | Number of subjects that reported vomiting as a treatment emergent adverse event during the study. | Safety Population: all randomized subjects who take at least 1 dose of study drug. | Posted | Jul 2011 | Number | | Participants | | Day 0 and Day 10/last visit | | | | ID | Title | Description |
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| OG000 | NUCYNTA | 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg | | OG001 | Oxycodone IR | 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg |
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| Secondary | Summary of Subjects Having Constipation as a Treatment-Emergent Adverse Event | Number of subjects that reported constipation as a treatment emergent adverse event during the study. | Safety Population: all randomized subjects who take at least 1 dose of study drug. | Posted | Jul 2011 | Number | | Participants | | Day 0 and Day 10/last visit | | | | ID | Title | Description |
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| OG000 | NUCYNTA | 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg | | OG001 | Oxycodone IR | 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg |
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| Secondary | Summary of Subjects Having Pruritus as a Treatment-Emergent Adverse Event | Number of subjects that reported pruritus as a treatment emergent adverse event during the study. | Safety Population: all randomized subjects who take at least 1 dose of study drug. | Posted | Jul 2011 | Number | | Participants | | Day 0 and Day 10/last visit | | | | ID | Title | Description |
|---|
| OG000 | NUCYNTA | 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg | | OG001 | Oxycodone IR | 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg |
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| Secondary | Kaplan-Meier First Time to 30% Response From Baseline for Low Back Pain | 30% response means >= 30% reduction from baseline in low back pain intensity score. | Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS). | Posted | Jul 2011 | Median | 95% Confidence Interval | Hours | | Day 0 and Day 10/last visit | | | | ID | Title | Description |
|---|
| OG000 | NUCYNTA | 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg | | OG001 | Oxycodone IR | 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg |
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| Secondary | Kaplan-Meier First Time to 50% Response From Baseline for Low Back Pain | 50% response means >= 50% reduction from baseline in low back pain intensity score. | Modified Intent-To-Treat Population: All randomized subjects who take at least 1 dose of study drug and have a baseline assessment of pain, and the baseline low back pain intensity assessment score ≥5 on an 11-point NRS (recorded via the IVRS). | Posted | Jul 2011 | Median | 95% Confidence Interval | Hours | | Day 0 and Day 10/last visit | | | | ID | Title | Description |
|---|
| OG000 | NUCYNTA | 50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg | | OG001 | Oxycodone IR | 5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg |
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