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The purpose of this study is to evaluate the efficacy of BEMA Fentanyl (Onsolis) at any dose in the management of breakthrough pain in cancer subjects on background opioid therapy. The standard of care for these breakthrough pain episodes is a rapid onset, short acting analgesic with minimal associated sleepiness. Oral morphine, oxycodone and hydromorphone are routinely used, but because of slow and variable oral absorption, the pain control is not the best with these products. Oral transmucosal fentanyl citrate (OTFC) has been used successfully in treating breakthrough pain episodes associated with cancer. OTFC is a lozenge of fentanyl on a stick and is administered by continuously swabbing the interior of the subject's mouth until the product is dissolved (approximately 15 to 30 minutes). The buccal route of administration avoids the delay and variability associated with oral absorption.
This is a randomized, double-blind, placebo controlled, multiple cross-over study. Eligible subjects will be treated with open label BEMA fentanyl over a period of up to two weeks. Doses will be titrated upward, starting at 200 μg, until a dose is identified that produces satisfactory pain relief for at least 2 episodes. Those subjects who identify a dose of BEMA fentanyl that produces satisfactory relief of breakthrough pain episodes will enter the double-blind, placebo controlled period of the trial. They will receive 3 placebo doses and 6 BEMA fentanyl doses in a random sequence per randomization schedule.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo |
|
| BEMAâ„¢ Fentanyl | Experimental | BioErodible MucoAdhesive (BEMA) Fentanyl |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BEMAâ„¢ | Drug | BioDelivery Sciences International, Inc. (BDSI) has developed BioErodible MucoAdhesive (BEMA) Fentanyl, an alternative product to OTFC that does not require the subject to continuously paint the inside of the mouth with the dosage form. The BDSI product is a small soluble film that is placed against the mucosal membrane inside the mouth. The mucoadhesive polymers in the film readily adhere to the mucosal membrane (within 5 seconds) when moistened. The components of the film are water soluble, so the entire dosage form dissolves within 30 minutes of application. |
| Measure | Description | Time Frame |
|---|---|---|
| Summary of Pain Intensity Differences (SPID) | Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study. SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes). Higher value indicates a better outcome. | 0-30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| SPID | Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study. SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes). Higher value indicates a better outcome.SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest. |
| Measure | Description | Time Frame |
|---|---|---|
| SPID in Neuropathic Pain Subpopulation | Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study. SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes). Higher value indicates a better outcome. SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest for the Neuropathic pain subpopulation for relevant time points (15, 30, 45, 60 minutes). Neuropathic pain subpopulation is a subset of ITT population who have neuropathic pain at baseline. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Finn, PharmD | BioDelivery Sciences International | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPD Development | Wilmington | North Carolina | 28412 | United States |
During the open-label titration period, subjects were treated with Onsolis at escalating doses (200, 400, 600, 800, and 1200 μg) over a period of up to two weeks until subjects identified a dose that produced satisfactory pain relief for at least two episodes.
24FEB2006 to 14MAR2007
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| ID | Title | Description |
|---|---|---|
| FG000 | Onsolis | Subjects were administered BEMA™ Fentanyl at escalating doses (200, 400, 600, 800, and 1200 μg) in Titration period. During the double-blind period, subjects were randomly assigned to a sequence of active and placebo discs. Each subject acted as his or her own control. For each subject, the sequencing of the placebo and BEMA™ Fentanyl discs was random. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Open-label Titration Period |
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| ||||||||||||||||||||||||
| Double-blind Treatment Period |
|
Safety Population
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| ID | Title | Description |
|---|---|---|
| BG000 | Onsolis | Includes all subjects and all dose levels |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Summary of Pain Intensity Differences (SPID) | Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study. SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes). Higher value indicates a better outcome. | In double-blind period, subjects received 3 doses placebo and 6 doses Onsolis. Mean SPID of Onsolis episodes and mean SPID of placebo episodes are calculated per subject and are used in analysis.Missing data were imputed on an episode-by-episode basis by carrying forward last observed data value (last observation carried forward [LOCF]). | Posted | Least Squares Mean | Standard Error | Score on a scale | 0-30 minutes | Breakthrough Pain (BTP) Episodes | Breakthrough Pain (BTP) Episodes |
A prior-treatment adverse event (AE) was defined as an AE that began before the first dose of the study drug. A treatment-emergent AE was defined as an AE that began on or after the initial dose of study medication up until the Follow-up Visit on Day 29.
At each visit, after the subject had an opportunity to spontaneously mention any problems, the investigator inquired about AEs by asking the following:
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Onsolis | All AEs were assigned to BEMAâ„¢ Fentanyl (Onsolis). Because of the multiple crossover design and the number of breakthrough pain episodes that usually occur during the day, it was likely that a subject would receive both active and placebo doses within a few hours of each other. Given the proximity of these different treatments, attempts to ascribe individual AEs to one treatment or another would be difficult, therefore, the chosen convention was to consider all AEs as occurring on active medication. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Splenomegaly | Blood and lymphatic system disorders | MedDRA 8.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
There were no limitations or caveats.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Larry Gever, PharmD, Director, Medical Affairs | Meda Pharmaceuticals Inc. | 732-564-2400 | larry.gever@meda.us |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Placebo | Drug |
|
| 0-5 minutes |
| SPID | Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study. SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes). Higher value indicates a better outcome.SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest. | 0-10 minutes |
| SPID | Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study. SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes). Higher value indicates a better outcome.SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest. | 0-15 minutes |
| SPID | Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study. SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes). Higher value indicates a better outcome.SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest. | 0-45 minutes |
| SPID | Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study. SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes). Higher value indicates a better outcome.SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest. | 0-60 minutes |
| PID | Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. | 5 minutes after dosing |
| PID | Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. | 10 minutes after dosing |
| PID | Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. | 15 minutes after dosing |
| PID | Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. | 30 minutes after dosing |
| PID | Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. | 45 minutes after dosing |
| PID | Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. | 60 minutes after dosing |
| Pain Relief | Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief) at 5, 10, 15, 30, 45, and 60 minutes after taking the study medication or until rescue. | 5 minutes after dosing |
| Pain Relief | Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief) at 5, 10, 15, 30, 45, and 60 minutes after taking the study medication or until rescue. | 10 minutes after dosing |
| Pain Relief | Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief) at 5, 10, 15, 30, 45, and 60 minutes after taking the study medication or until rescue. | 15 minutes after dosing |
| Pain Relief | Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief) at 5, 10, 15, 30, 45, and 60 minutes after taking the study medication or until rescue. | 30 minutes after dosing |
| Pain Relief | Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief) at 5, 10, 15, 30, 45, and 60 minutes after taking the study medication or until rescue. | 45 minutes after dosing |
| Pain Relief | Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief) at 5, 10, 15, 30, 45, and 60 minutes after taking the study medication or until rescue. | 60 minutes after dosing |
| Total Pain Relief | Total Pain Relief (TOTPAR) is calculated as the weighted sum of the pain relief (PR) of all time points at or prior to the time point of interest.Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief)compared to baseline (pre-dose) | 5 minutes |
| Total Pain Relief | Total Pain Relief (TOTPAR) is calculated as the weighted sum of the pain relief (PR) of all time points at or prior to the time point of interest. Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief)compared to baseline (pre-dose) | 10 minutes |
| Total Pain Relief | Total Pain Relief (TOTPAR) is calculated as the weighted sum of the pain relief (PR) of all time points at or prior to the time point of interest. Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief)compared to baseline (pre-dose) | 15 minutes |
| Total Pain Relief | Total Pain Relief (TOTPAR) is calculated as the weighted sum of the pain relief (PR) of all time points at or prior to the time point of interest. Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief)compared to baseline (pre-dose) | 30 minutes |
| Total Pain Relief | Total Pain Relief (TOTPAR) is calculated as the weighted sum of the pain relief (PR) of all time points at or prior to the time point of interest. Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief)compared to baseline (pre-dose) | 45 minutes |
| Total Pain Relief | Total Pain Relief (TOTPAR) is calculated as the weighted sum of the pain relief (PR) of all time points at or prior to the time point of interest. Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief)compared to baseline (pre-dose) | 60 minutes |
| Subject Overall Satisfaction With Study Drug | Subjects evaluated their overall satisfaction with study drug at the time rescue medication was consumed or at the 60-minute time point using a 5-point categorical scale (0 = poor, 1 = fair, 2 = good, 3 = very good, and 4 = excellent). | 60 minutes or at time of rescue medication use |
| Percentage of Pain Free Episodes | A pain free episode is one with 0 pain intensity at the specified time point. Percentage of episodes that are pain-free per subject is analyzed. | 5 minutes |
| Percentage of Pain Free Episodes | A pain free episode is one with 0 pain intensity at the specified time point. Percentage of episodes that are pain-free per subject is analyzed. | 10 minutes |
| Percentage of Pain Free Episodes | A pain free episode is one with 0 pain intensity at the specified time point. Percentage of episodes that are pain-free per subject is analyzed. | 15 minutes |
| Percentage of Pain Free Episodes | A pain free episode is one with 0 pain intensity at the specified time point. Percentage of episodes that are pain-free per subject is analyzed. | 30 minutes |
| Percentage of Pain Free Episodes | A pain free episode is one with 0 pain intensity at the specified time point. Percentage of episodes that are pain-free per subject is analyzed. | 45 minutes |
| Percentage of Pain Free Episodes | A pain free episode is one with 0 pain intensity at the specified time point. Percentage of episodes that are pain-free per subject is analyzed. | 60 minutes |
| Episodes With at Least 50% Decreases in Pain | Number of episodes where the total pain score has at least a 50% reduction from baseline. | 15 minutes |
| Episodes With at Least 50% Decreases in Pain | Number of episodes where the total pain score has at least a 50% reduction from baseline. | 30 minutes |
| Episodes With at Least 50% Decreases in Pain | Number of episodes where the total pain score has at least a 50% reduction from baseline. | 45 minutes |
| Episodes With at Least 50% Decreases in Pain | Number of episodes where the total pain score has at least a 50% reduction from baseline. | 60 minutes |
| Episodes With at Least 33% Decreases in Pain | Number of episodes where the total pain score has at least a 33% reduction from baseline. | 15 minutes |
| Episodes With at Least 33% Decreases in Pain | Number of episodes where the total pain score has at least a 33% reduction from baseline. | 30 minutes |
| Episodes With at Least 33% Decreases in Pain | Number of episodes where the total pain score has at least a 33% reduction from baseline. | 45 minutes |
| Episodes With at Least 33% Decreases in Pain | Number of episodes where the total pain score has at least a 50% reduction from baseline. | 60 minutes |
| Episodes With Complete Pain Relief | Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief). Percentage of episodes with complete relief per subject is analyzed where a complete pain relief episode is defined as pain relief of value 4 at the specified time point. | 5 minutes |
| Episodes With Complete Pain Relief | Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief).Percentage of episodes with complete relief per subject is analyzed where a complete pain relief episode is defined as pain relief of value 4 at the specified time point. | 10 minutes |
| Episodes With Complete Pain Relief | Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief).Percentage of episodes with complete relief per subject is analyzed where a complete pain relief episode is defined as pain relief of value 4 at the specified time point. | 15 minutes |
| Episodes With Complete Pain Relief | Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief). Percentage of episodes with complete relief per subject is analyzed where a complete pain relief episode is defined as pain relief of value 4 at the specified time point. | 30 minutes |
| Episodes With Complete Pain Relief | Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief). Percentage of episodes with complete relief per subject is analyzed where a complete pain relief episode is defined as pain relief of value 4 at the specified time point. | 45 minutes |
| Episodes With Complete Pain Relief | Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief). Percentage of episodes with complete relief per subject is analyzed where a complete pain relief episode is defined as pain relief of value 4 at the specified time point. | 60 minutes |
| Rescue Medication Usage | Rescue medication is medication taken if adequate pain relief is not realized within 30 minutes following application of the study drug. Percentage of episodes when rescue medication was used per subject is analyzed. | 28 Days |
| 15 minutes |
| SPID in Neuropathic Pain Subpopulation | Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study. SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes). Higher value indicates a better outcome. SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest for the Neuropathic pain subpopulation for relevant time points (15, 30, 45, 60 minutes). Neuropathic pain subpopulation is a subset of ITT population who have neuropathic pain at baseline. | 30 minutes |
| SPID in Neuropathic Pain Subpopulation | Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study. SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes). Higher value indicates a better outcome. SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest for the Neuropathic pain subpopulation for relevant time points (15, 30, 45, 60 minutes). Neuropathic pain subpopulation is a subset of ITT population who have neuropathic pain at baseline. | 45 minutes |
| SPID in Neuropathic Pain Subpopulation | Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study. SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes). Higher value indicates a better outcome. SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest for the Neuropathic pain subpopulation for relevant time points (15, 30, 45, 60 minutes). Neuropathic pain subpopulation is a subset of ITT population who have neuropathic pain at baseline. | 60 minutes |
| Protocol Violation |
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| Withdrawal by Subject |
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| Noncompliance and other |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Female reproductive status | Count of Participants | Participants |
|
| Height (inches) | Mean | Standard Deviation | Inches |
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| Weight (pounds) | Mean | Standard Deviation | pounds |
|
| ID | Title | Description |
|---|
| OG000 | Onsolis | BioErodible MucoAdhesive (BEMA) Fentanyl |
| OG001 | Placebo | Placebo Disc |
|
|
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| Secondary | SPID | Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study. SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes). Higher value indicates a better outcome.SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest. | Posted | Least Squares Mean | Standard Error | Scores on a scale | 0-5 minutes | BTP Episodes | BTP Episodes |
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|
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| Secondary | SPID | Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study. SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes). Higher value indicates a better outcome.SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest. | Posted | Least Squares Mean | Standard Error | Scores on a scale | 0-10 minutes | BTP Episodes | BTP Episodes |
|
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| Secondary | SPID | Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study. SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes). Higher value indicates a better outcome.SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest. | Posted | Least Squares Mean | Standard Error | Scores on a scale | 0-15 minutes | BTP Episodes | BTP Episodes |
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| Secondary | SPID | Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study. SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes). Higher value indicates a better outcome.SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest. | Posted | Least Squares Mean | Standard Error | Scores on a scale | 0-45 minutes | BTP Episodes | BTP Episodes |
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| Secondary | SPID | Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study. SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes). Higher value indicates a better outcome.SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest. | Posted | Least Squares Mean | Standard Error | Scores on a scale | 0-60 minutes | BTP Episodes | BTP Episodes |
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| Secondary | PID | Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. | During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis. All efficacy analyses were conducted using the intent-to-treat (ITT) population. Last observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage. | Posted | Mean | Standard Error | Scores on a scale | 5 minutes after dosing | BTP Episodes | BTP Episodes |
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| Secondary | PID | Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. | Posted | Mean | Standard Error | Scores on a scale | 10 minutes after dosing | BTP Episodes | BTP Episodes |
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| Secondary | PID | Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. | Posted | Mean | Standard Error | Scores on a scale | 15 minutes after dosing | BTP Episodes | BTP Episodes |
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| Secondary | PID | Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. | Posted | Mean | Standard Error | Scores on a scale | 30 minutes after dosing | BTP Episodes | BTP Episodes |
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| Secondary | PID | Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. | Posted | Mean | Standard Error | Scores on a scale | 45 minutes after dosing | BTP Episodes | BTP Episodes |
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| Secondary | PID | Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. | Posted | Mean | Standard Error | Scores on a scale | 60 minutes after dosing | BTP Episodes | BTP Episodes |
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| Secondary | Pain Relief | Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief) at 5, 10, 15, 30, 45, and 60 minutes after taking the study medication or until rescue. | During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis. All efficacy analyses were conducted using the intent-to-treat (ITT) population. Last observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage. | Posted | Mean | Standard Error | Scores on a scale | 5 minutes after dosing | BTP Episodes | BTP Episodes |
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| Secondary | Pain Relief | Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief) at 5, 10, 15, 30, 45, and 60 minutes after taking the study medication or until rescue. | During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis. All efficacy analyses were conducted using the intent-to-treat (ITT) population. Last observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage. | Posted | Mean | Standard Error | Scores on a scale | 10 minutes after dosing | BTP Episodes | BTP Episodes |
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| Secondary | Pain Relief | Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief) at 5, 10, 15, 30, 45, and 60 minutes after taking the study medication or until rescue. | During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis. All efficacy analyses were conducted using the intent-to-treat (ITT) population. Last observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage. | Posted | Mean | Standard Error | Scores on a scale | 15 minutes after dosing | BTP Episodes | BTP Episodes |
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| Secondary | Pain Relief | Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief) at 5, 10, 15, 30, 45, and 60 minutes after taking the study medication or until rescue. | During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis. All efficacy analyses were conducted using the intent-to-treat (ITT) population. Last observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage. | Posted | Mean | Standard Error | Scores on a scale | 30 minutes after dosing | BTP Episodes | BTP Episodes |
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| Secondary | Pain Relief | Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief) at 5, 10, 15, 30, 45, and 60 minutes after taking the study medication or until rescue. | During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis. All efficacy analyses were conducted using the intent-to-treat (ITT) population. Last observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage. | Posted | Mean | Standard Error | Scores on a scale | 45 minutes after dosing | BTP Episodes | BTP Episodes |
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| Secondary | Pain Relief | Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief) at 5, 10, 15, 30, 45, and 60 minutes after taking the study medication or until rescue. | During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis. All efficacy analyses were conducted using the intent-to-treat (ITT) population. Last observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage. | Posted | Mean | Standard Error | Scores on a scale | 60 minutes after dosing | BTP Episodes | BTP Episodes |
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| Secondary | Total Pain Relief | Total Pain Relief (TOTPAR) is calculated as the weighted sum of the pain relief (PR) of all time points at or prior to the time point of interest.Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief)compared to baseline (pre-dose) | During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis. All efficacy analyses were conducted using the intent-to-treat (ITT) population. Last observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage. | Posted | Mean | Standard Error | Scores on a scale | 5 minutes | BTP Episodes | BTP Episodes |
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| Secondary | Total Pain Relief | Total Pain Relief (TOTPAR) is calculated as the weighted sum of the pain relief (PR) of all time points at or prior to the time point of interest. Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief)compared to baseline (pre-dose) | During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis. All efficacy analyses were conducted using the intent-to-treat (ITT) population. Last observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage. | Posted | Mean | Standard Error | Scores on a scale | 10 minutes | BTP Episodes | BTP Episodes |
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| Secondary | Total Pain Relief | Total Pain Relief (TOTPAR) is calculated as the weighted sum of the pain relief (PR) of all time points at or prior to the time point of interest. Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief)compared to baseline (pre-dose) | During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis. All efficacy analyses were conducted using the intent-to-treat (ITT) population. Last observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage. | Posted | Mean | Standard Error | Scores on a scale | 15 minutes | BTP Episodes | BTP Episodes |
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| Secondary | Total Pain Relief | Total Pain Relief (TOTPAR) is calculated as the weighted sum of the pain relief (PR) of all time points at or prior to the time point of interest. Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief)compared to baseline (pre-dose) | During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis. All efficacy analyses were conducted using the intent-to-treat (ITT) population. Last observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage. | Posted | Mean | Standard Error | Scores on a scale | 30 minutes | BTP Episodes | BTP Episodes |
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| Secondary | Total Pain Relief | Total Pain Relief (TOTPAR) is calculated as the weighted sum of the pain relief (PR) of all time points at or prior to the time point of interest. Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief)compared to baseline (pre-dose) | During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis. All efficacy analyses were conducted using the intent-to-treat (ITT) population. Last observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage. | Posted | Mean | Standard Error | Scores on a scale | 45 minutes | BTP Episodes | BTP Episodes |
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| Secondary | Total Pain Relief | Total Pain Relief (TOTPAR) is calculated as the weighted sum of the pain relief (PR) of all time points at or prior to the time point of interest. Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief)compared to baseline (pre-dose) | During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis. All efficacy analyses were conducted using the intent-to-treat (ITT) population. Last observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage. | Posted | Mean | Standard Error | Scores on a scale | 60 minutes | BTP Episodes | BTP Episodes |
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| Secondary | Subject Overall Satisfaction With Study Drug | Subjects evaluated their overall satisfaction with study drug at the time rescue medication was consumed or at the 60-minute time point using a 5-point categorical scale (0 = poor, 1 = fair, 2 = good, 3 = very good, and 4 = excellent). | All efficacy analyses were conducted using the intent-to-treat (ITT) population. | Posted | Mean | Standard Error | Scores on a scale | 60 minutes or at time of rescue medication use | Subject Overall Satisfaction | Subject Overall Satisfaction |
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| Secondary | Percentage of Pain Free Episodes | A pain free episode is one with 0 pain intensity at the specified time point. Percentage of episodes that are pain-free per subject is analyzed. | During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis. All efficacy analyses were conducted using the intent-to-treat (ITT) population, however, only available data is summarized here. | Posted | Mean | Standard Error | percentage of episodes | 5 minutes |
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| Secondary | Percentage of Pain Free Episodes | A pain free episode is one with 0 pain intensity at the specified time point. Percentage of episodes that are pain-free per subject is analyzed. | During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis. All efficacy analyses were conducted using the intent-to-treat (ITT) population. Last observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage. | Posted | Mean | Standard Error | percentage of episodes | 10 minutes |
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| Secondary | Percentage of Pain Free Episodes | A pain free episode is one with 0 pain intensity at the specified time point. Percentage of episodes that are pain-free per subject is analyzed. | During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis. All efficacy analyses were conducted using the intent-to-treat (ITT) population. Last observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage. | Posted | Mean | Standard Error | percentage of episodes | 15 minutes |
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| Secondary | Percentage of Pain Free Episodes | A pain free episode is one with 0 pain intensity at the specified time point. Percentage of episodes that are pain-free per subject is analyzed. | During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis. All efficacy analyses were conducted using the intent-to-treat (ITT) population. Last observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage. | Posted | Mean | Standard Error | percentage of episodes | 30 minutes |
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| Secondary | Percentage of Pain Free Episodes | A pain free episode is one with 0 pain intensity at the specified time point. Percentage of episodes that are pain-free per subject is analyzed. | During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis. All efficacy analyses were conducted using the intent-to-treat (ITT) population. Last observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage. | Posted | Mean | Standard Error | percentage of episodes | 45 minutes |
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| Secondary | Percentage of Pain Free Episodes | A pain free episode is one with 0 pain intensity at the specified time point. Percentage of episodes that are pain-free per subject is analyzed. | During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis. All efficacy analyses were conducted using the intent-to-treat (ITT) population. Last observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage. | Posted | Mean | Standard Error | percentage of episodes | 60 minutes |
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| Secondary | Episodes With at Least 50% Decreases in Pain | Number of episodes where the total pain score has at least a 50% reduction from baseline. | During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis. All efficacy analyses were conducted using the intent-to-treat (ITT) population. Last observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage. | Posted | Mean | Standard Error | episodes | 15 minutes |
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| Secondary | Episodes With at Least 50% Decreases in Pain | Number of episodes where the total pain score has at least a 50% reduction from baseline. | During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis. All efficacy analyses were conducted using the intent-to-treat (ITT) population. Last observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage. | Posted | Mean | Standard Error | episodes | 30 minutes |
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| Secondary | Episodes With at Least 50% Decreases in Pain | Number of episodes where the total pain score has at least a 50% reduction from baseline. | During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis. All efficacy analyses were conducted using the intent-to-treat (ITT) population. Last observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage. | Posted | Mean | Standard Error | episodes | 45 minutes |
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| Secondary | Episodes With at Least 50% Decreases in Pain | Number of episodes where the total pain score has at least a 50% reduction from baseline. | During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis. All efficacy analyses were conducted using the intent-to-treat (ITT) population. Last observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage. | Posted | Mean | Standard Error | episodes | 60 minutes |
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| Secondary | Episodes With at Least 33% Decreases in Pain | Number of episodes where the total pain score has at least a 33% reduction from baseline. | During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis. All efficacy analyses were conducted using the intent-to-treat (ITT) population. Last observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage. | Posted | Mean | Standard Error | episodes | 15 minutes |
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| Secondary | Episodes With at Least 33% Decreases in Pain | Number of episodes where the total pain score has at least a 33% reduction from baseline. | During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis. All efficacy analyses were conducted using the intent-to-treat (ITT) population. Last observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage. | Posted | Mean | Standard Error | episodes | 30 minutes |
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| Secondary | Episodes With at Least 33% Decreases in Pain | Number of episodes where the total pain score has at least a 33% reduction from baseline. | During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis. All efficacy analyses were conducted using the intent-to-treat (ITT) population. Last observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage. | Posted | Mean | Standard Error | episodes | 45 minutes |
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| Secondary | Episodes With at Least 33% Decreases in Pain | Number of episodes where the total pain score has at least a 50% reduction from baseline. | During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis. All efficacy analyses were conducted using the intent-to-treat (ITT) population. Last observation carried forward (LOCF) is used to impute missing data or data after rescue medication usage. | Posted | Mean | Standard Error | episodes | 60 minutes |
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| Secondary | Episodes With Complete Pain Relief | Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief). Percentage of episodes with complete relief per subject is analyzed where a complete pain relief episode is defined as pain relief of value 4 at the specified time point. | All efficacy analyses were conducted using the intent-to-treat (ITT) population. | Posted | Mean | Standard Error | percentage of episodes | 5 minutes |
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| Secondary | Episodes With Complete Pain Relief | Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief).Percentage of episodes with complete relief per subject is analyzed where a complete pain relief episode is defined as pain relief of value 4 at the specified time point. | All efficacy analyses were conducted using the intent-to-treat (ITT) population. | Posted | Mean | Standard Error | percentage of episodes | 10 minutes |
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| Secondary | Episodes With Complete Pain Relief | Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief).Percentage of episodes with complete relief per subject is analyzed where a complete pain relief episode is defined as pain relief of value 4 at the specified time point. | All efficacy analyses were conducted using the intent-to-treat (ITT) population. | Posted | Mean | Standard Error | percentage of episodes | 15 minutes |
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| Secondary | Episodes With Complete Pain Relief | Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief). Percentage of episodes with complete relief per subject is analyzed where a complete pain relief episode is defined as pain relief of value 4 at the specified time point. | All efficacy analyses were conducted using the intent-to-treat (ITT) population. | Posted | Mean | Standard Error | percentage of episodes | 30 minutes |
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| Secondary | Episodes With Complete Pain Relief | Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief). Percentage of episodes with complete relief per subject is analyzed where a complete pain relief episode is defined as pain relief of value 4 at the specified time point. | All efficacy analyses were conducted using the intent-to-treat (ITT) population. | Posted | Mean | Standard Error | percentage of episodes | 45 minutes |
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| Secondary | Episodes With Complete Pain Relief | Pain relief (PR) is measured using a 5-point categorical scale (0=no relief to 4=complete relief). Percentage of episodes with complete relief per subject is analyzed where a complete pain relief episode is defined as pain relief of value 4 at the specified time point. | All efficacy analyses were conducted using the intent-to-treat (ITT) population. | Posted | Mean | Standard Error | percentage of episodes | 60 minutes |
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| Secondary | Rescue Medication Usage | Rescue medication is medication taken if adequate pain relief is not realized within 30 minutes following application of the study drug. Percentage of episodes when rescue medication was used per subject is analyzed. | All efficacy analyses were conducted using the intent-to-treat (ITT) population. | Posted | Mean | Standard Error | percentage of episodes | 28 Days |
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| Other Pre-specified | SPID in Neuropathic Pain Subpopulation | Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study. SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes). Higher value indicates a better outcome. SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest for the Neuropathic pain subpopulation for relevant time points (15, 30, 45, 60 minutes). Neuropathic pain subpopulation is a subset of ITT population who have neuropathic pain at baseline. | During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis. All efficacy analyses were conducted using the intent-to-treat (ITT) population. Missing data were imputed on an episode-by-episode basis by carrying forward the last observed data value (last observation carried forward [LOCF]). | Posted | Least Squares Mean | Standard Error | Scores on a scale | 15 minutes |
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| Other Pre-specified | SPID in Neuropathic Pain Subpopulation | Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study. SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes). Higher value indicates a better outcome. SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest for the Neuropathic pain subpopulation for relevant time points (15, 30, 45, 60 minutes). Neuropathic pain subpopulation is a subset of ITT population who have neuropathic pain at baseline. | During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis. All efficacy analyses were conducted using the intent-to-treat (ITT) population. Missing data were imputed on an episode-by-episode basis by carrying forward the last observed data value (last observation carried forward [LOCF]). | Posted | Least Squares Mean | Standard Error | Scores on a scale | 30 minutes |
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| Other Pre-specified | SPID in Neuropathic Pain Subpopulation | Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study. SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes). Higher value indicates a better outcome. SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest for the Neuropathic pain subpopulation for relevant time points (15, 30, 45, 60 minutes). Neuropathic pain subpopulation is a subset of ITT population who have neuropathic pain at baseline. | During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis. All efficacy analyses were conducted using the intent-to-treat (ITT) population. Missing data were imputed on an episode-by-episode basis by carrying forward the last observed data value (last observation carried forward [LOCF]). | Posted | Least Squares Mean | Standard Error | Scores on a scale | 45 minutes |
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| Other Pre-specified | SPID in Neuropathic Pain Subpopulation | Pain intensity (using an 11-point [0 = no pain to 10 = worst pain] numeric scale) was recorded at 0, 5, 10, 15, 30, 45, and 60 minutes after dosing. Pain intensity difference (PID) was defined as the baseline pain score minus the pain score of each time point. The primary endpoint was the Summary of Pain Intensity Differences at 30 minutes after dosing (SPID 30) in ITT population for Onsolis versus placebo during double-blind period of study. SPID was calculated as a weighted sum of the PID of all time points at or before time point of interest.Range of possible SPID values is -10X time point (minutes) to 10X time point (minutes). Higher value indicates a better outcome. SPID was calculated as a weighted sum of the pain intensity difference of all time points at or before the time point of interest for the Neuropathic pain subpopulation for relevant time points (15, 30, 45, 60 minutes). Neuropathic pain subpopulation is a subset of ITT population who have neuropathic pain at baseline. | During the double-blind period, subjects received 3 doses of placebo and 6 doses of Onsolis. All efficacy analyses were conducted using the intent-to-treat (ITT) population. Missing data were imputed on an episode-by-episode basis by carrying forward the last observed data value (last observation carried forward [LOCF]). | Posted | Least Squares Mean | Standard Error | Scores on a scale | 60 minutes |
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| 23 |
| 151 |
| 44 |
| 151 |
| Gastrointestinal hemorrhage | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
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| Hematemesis | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
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| Intestinal obstruction | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
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| Esophageal hemorrhage | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 8.1 | Systematic Assessment |
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| Bile duct obstruction | Hepatobiliary disorders | MedDRA 8.1 | Systematic Assessment |
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| Hepatic failure | Hepatobiliary disorders | MedDRA 8.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 8.1 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 8.1 | Systematic Assessment |
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| Failure to thrive | Metabolism and nutrition disorders | MedDRA 8.1 | Systematic Assessment |
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| Hypoglycemia | Metabolism and nutrition disorders | MedDRA 8.1 | Systematic Assessment |
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| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Systematic Assessment |
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| Vaginal cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.1 | Systematic Assessment |
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| Grand mal convulsion | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
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| Confusional state | Psychiatric disorders | MedDRA 8.1 | Systematic Assessment |
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| Renal failure acute | Renal and urinary disorders | MedDRA 8.1 | Systematic Assessment |
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| Hemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Systematic Assessment |
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| Arterial thrombosis limb | Vascular disorders | MedDRA 8.1 | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA 8.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 8.1 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 8.1 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 8.1 | Systematic Assessment |
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The oral or written use of study results by the investigator are not permitted without the express written consent from BDSI. All data resulting from this study remain property of BDSI.