Trial Outcomes & Findings for Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Chronic Low Back Pain (NCT NCT00490919)
NCT ID: NCT00490919
Last Updated: 2012-09-10
Results Overview
Pain was assessed on an 11-point numerical scale ranging from 0 = no pain to 10 = pain as bad as you can imagine.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
539 participants
Primary outcome timeframe
Prerandomization phase consisted of a 6-10 day screening period and a <27 day open-label run-in period; and a 12-week double-blind phase.
Results posted on
2012-09-10
Participant Flow
Study dates: 27-Jun-2007 (first patient first visit) to 24-Jul-2008 (last patient last visit), at 86 medical/research sites in the USA.
The open-label run-in period (N = 1024 started) was designed to select subjects for randomization in the double-blind phase who met both tolerability and responsiveness criteria for either BTDS 10 or 20 (an enriched design).
Participant milestones
| Measure |
Open-label Run-in Period
The open-label run-in period (\< 27 days) (N = 1024 started) was designed to select subjects for randomization who met both tolerability and responsiveness criteria for either BTDS 10 or 20 (an enriched design).
Upon completion of the run-in period, 541 subjects were randomized and received treatment in the double-blind phase. Two subjects had no safety data after the randomization visit; therefore N = 539 for the randomized safety population.
|
Double-blind BTDS 10 or 20
Buprenorphine transdermal patch (BTDS) 10 mcg/h or 20 mcg/h applied for 7-day wear during the 12-week double-blind phase.
|
Double-blind Placebo TDS
Matching placebo transdermal patch (placebo TDS) 10 or 20 mcg/h applied for 7-day wear during the 12-week double-blind phase.
|
|---|---|---|---|
|
Open-label Run-in Period
STARTED
|
1024
|
0
|
0
|
|
Open-label Run-in Period
COMPLETED
|
541
|
0
|
0
|
|
Open-label Run-in Period
NOT COMPLETED
|
483
|
0
|
0
|
|
Double-blind Phase
STARTED
|
0
|
256
|
283
|
|
Double-blind Phase
COMPLETED
|
0
|
170
|
199
|
|
Double-blind Phase
NOT COMPLETED
|
0
|
86
|
84
|
Reasons for withdrawal
| Measure |
Open-label Run-in Period
The open-label run-in period (\< 27 days) (N = 1024 started) was designed to select subjects for randomization who met both tolerability and responsiveness criteria for either BTDS 10 or 20 (an enriched design).
Upon completion of the run-in period, 541 subjects were randomized and received treatment in the double-blind phase. Two subjects had no safety data after the randomization visit; therefore N = 539 for the randomized safety population.
|
Double-blind BTDS 10 or 20
Buprenorphine transdermal patch (BTDS) 10 mcg/h or 20 mcg/h applied for 7-day wear during the 12-week double-blind phase.
|
Double-blind Placebo TDS
Matching placebo transdermal patch (placebo TDS) 10 or 20 mcg/h applied for 7-day wear during the 12-week double-blind phase.
|
|---|---|---|---|
|
Open-label Run-in Period
Adverse Event
|
239
|
0
|
0
|
|
Open-label Run-in Period
Withdrawal by Subject
|
37
|
0
|
0
|
|
Open-label Run-in Period
Lost to Follow-up
|
21
|
0
|
0
|
|
Open-label Run-in Period
Lack of Efficacy
|
143
|
0
|
0
|
|
Open-label Run-in Period
Administrative
|
40
|
0
|
0
|
|
Open-label Run-in Period
Confirmed or suspected diversion
|
3
|
0
|
0
|
|
Double-blind Phase
Adverse Event
|
0
|
40
|
20
|
|
Double-blind Phase
Withdrawal by Subject
|
0
|
10
|
11
|
|
Double-blind Phase
Lost to Follow-up
|
0
|
8
|
11
|
|
Double-blind Phase
Lack of Efficacy
|
0
|
22
|
36
|
|
Double-blind Phase
Administrative
|
0
|
6
|
6
|
Baseline Characteristics
Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Chronic Low Back Pain
Baseline characteristics by cohort
| Measure |
Double-blind BTDS
n=256 Participants
Buprenorphine transdermal patch 10 mcg/h or 20 mcg/h applied for 7-day wear during the 12-week double-blind phase
|
Double-blind Placebo TDS
n=283 Participants
Matching placebo TDS 10 or 20 mcg/h applied for 7-day wear during the 12-week double-blind phase
|
Total
n=539 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
48.9 years
STANDARD_DEVIATION 12.50 • n=5 Participants
|
50.1 years
STANDARD_DEVIATION 13.31 • n=7 Participants
|
49.5 years
STANDARD_DEVIATION 12.93 • n=5 Participants
|
|
Sex: Female, Male
Female
|
133 Participants
n=5 Participants
|
163 Participants
n=7 Participants
|
296 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
123 Participants
n=5 Participants
|
120 Participants
n=7 Participants
|
243 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Prerandomization phase consisted of a 6-10 day screening period and a <27 day open-label run-in period; and a 12-week double-blind phase.Population: The full analysis population (FAP) (N = 541) \[539\] consisted of subjects who were randomized and received at least 1 dose of the double-blind study drug. (Two subjects did not have safety data.)
Pain was assessed on an 11-point numerical scale ranging from 0 = no pain to 10 = pain as bad as you can imagine.
Outcome measures
| Measure |
Double-blind BTDS
n=256 Participants
Buprenorphine transdermal patch 10 mcg/h or 20 mcg/h applied for 7-day wear during the 12-week double-blind phase
|
Double-blind Placebo TDS
n=283 Participants
Matching placebo TDS 10 or 20 mcg/h applied for 7-day wear during the 12-week double-blind phase
|
|---|---|---|
|
Average Pain Over the Last 24 Hours Scores at Week 12 of the Double-blind Phase.
Screening
|
7.24 Units on a scale
Standard Deviation 1.263
|
7.17 Units on a scale
Standard Deviation 1.223
|
|
Average Pain Over the Last 24 Hours Scores at Week 12 of the Double-blind Phase.
Prerandomization
|
2.57 Units on a scale
Standard Deviation 1.283
|
2.56 Units on a scale
Standard Deviation 1.207
|
|
Average Pain Over the Last 24 Hours Scores at Week 12 of the Double-blind Phase.
Week 12 - Primary outcome
|
3.83 Units on a scale
Standard Deviation 2.738
|
4.38 Units on a scale
Standard Deviation 2.690
|
SECONDARY outcome
Timeframe: weeks 2-12Population: Subjects in the full analysis population who took at least one dose of supplemental analgesic medication.
Nonopioid supplemental analgesic tablets were sponsor-supplied acetaminophen or ibuprofen.
Outcome measures
| Measure |
Double-blind BTDS
n=137 Participants
Buprenorphine transdermal patch 10 mcg/h or 20 mcg/h applied for 7-day wear during the 12-week double-blind phase
|
Double-blind Placebo TDS
n=180 Participants
Matching placebo TDS 10 or 20 mcg/h applied for 7-day wear during the 12-week double-blind phase
|
|---|---|---|
|
The Mean Daily Number of Tablets of Nonopioid Supplemental Analgesic Medications Taken During Weeks 2 Through 12 of the Double-blind Phase
|
0.620 tablets
Standard Error 0.0658
|
0.743 tablets
Standard Error 0.0574
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12 of double-blind phasePopulation: The full analysis population (FAP) (N = 541) consisted of subjects who were randomized and received at least 1 dose of the double-blind study drug. 2 subjects did not have safety data (N = 539).
The MOS Sleep Scale consists of 12 individual items (4 sleep disturbance, 2 sleep adequacy, 1 quantity of and optimal sleep, 3 somnolence, 1 snoring, and 1 shortness of breath) and takes 5 to 10 minutes to complete. Question 1 is scored on a scale of 1 to 5 and Questions 2 to 12 are scored on a scale of 1 to 6. The Sleep Disturbance Subscale score is derived from the scores to Questions 1, 3, 7 and 8, and ranges from 0 to 100, where higher scores indicate greater sleep disturbance.
Outcome measures
| Measure |
Double-blind BTDS
n=256 Participants
Buprenorphine transdermal patch 10 mcg/h or 20 mcg/h applied for 7-day wear during the 12-week double-blind phase
|
Double-blind Placebo TDS
n=283 Participants
Matching placebo TDS 10 or 20 mcg/h applied for 7-day wear during the 12-week double-blind phase
|
|---|---|---|
|
The Sleep Disturbance Subscale in the Medical Outcome Study (MOS) Sleep Scale at Weeks 4, 8, and 12 of the Double-blind Phase
Week 4
|
32.84 Units on a scale
Standard Deviation 25.552
|
41.20 Units on a scale
Standard Deviation 26.813
|
|
The Sleep Disturbance Subscale in the Medical Outcome Study (MOS) Sleep Scale at Weeks 4, 8, and 12 of the Double-blind Phase
Week 8
|
35.63 Units on a scale
Standard Deviation 26.276
|
39.87 Units on a scale
Standard Deviation 26.362
|
|
The Sleep Disturbance Subscale in the Medical Outcome Study (MOS) Sleep Scale at Weeks 4, 8, and 12 of the Double-blind Phase
Week 12
|
34.97 Units on a scale
Standard Deviation 26.871
|
40.42 Units on a scale
Standard Deviation 26.675
|
Adverse Events
Double-blind BTDS 10, 20
Serious events: 3 serious events
Other events: 52 other events
Deaths: 0 deaths
Double-blind Placebo TDS 10, 20
Serious events: 2 serious events
Other events: 63 other events
Deaths: 0 deaths
Open-label Run-in Period, BTDS 5, 10, 20
Serious events: 4 serious events
Other events: 437 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Double-blind BTDS 10, 20
n=256 participants at risk
Buprenorphine transdermal patch 10 mcg/h or 20 mcg/h applied for 7-day wear
|
Double-blind Placebo TDS 10, 20
n=283 participants at risk
Matching placebo TDS 10 or 20 applied for 7-day wear
|
Open-label Run-in Period, BTDS 5, 10, 20
n=1024 participants at risk
Open-label BTDS 5, 10, 20 applied for 7-day wear
|
|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/256 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
0.35%
1/283 • Number of events 1 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
0.00%
0/1024 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/256 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
0.00%
0/283 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
0.10%
1/1024 • Number of events 1 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/256 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
0.00%
0/283 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
0.10%
1/1024 • Number of events 1 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.39%
1/256 • Number of events 1 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
0.00%
0/283 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
0.10%
1/1024 • Number of events 1 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/256 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
0.00%
0/283 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
0.10%
1/1024 • Number of events 1 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/256 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
0.00%
0/283 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
0.10%
1/1024 • Number of events 1 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.00%
0/256 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
0.00%
0/283 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
0.10%
1/1024 • Number of events 1 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
|
Nervous system disorders
Subarachnoid hemorrhage
|
0.00%
0/256 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
0.00%
0/283 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
0.10%
1/1024 • Number of events 1 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
|
Psychiatric disorders
Major depression
|
0.39%
1/256 • Number of events 1 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
0.00%
0/283 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
0.00%
0/1024 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
|
Psychiatric disorders
Homicidal thoughts
|
0.00%
0/256 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
0.35%
1/283 • Number of events 1 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
0.00%
0/1024 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/256 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
0.35%
1/283 • Number of events 1 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
0.00%
0/1024 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/256 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
0.35%
1/283 • Number of events 1 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
0.00%
0/1024 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/256 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
0.00%
0/283 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
0.10%
1/1024 • Number of events 1 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
|
Social circumstances
Drug abuser
|
0.39%
1/256 • Number of events 1 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
0.00%
0/283 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
0.00%
0/1024 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
Other adverse events
| Measure |
Double-blind BTDS 10, 20
n=256 participants at risk
Buprenorphine transdermal patch 10 mcg/h or 20 mcg/h applied for 7-day wear
|
Double-blind Placebo TDS 10, 20
n=283 participants at risk
Matching placebo TDS 10 or 20 applied for 7-day wear
|
Open-label Run-in Period, BTDS 5, 10, 20
n=1024 participants at risk
Open-label BTDS 5, 10, 20 applied for 7-day wear
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
12.5%
32/256 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
11.0%
31/283 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
23.4%
240/1024 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
|
Gastrointestinal disorders
Vomiting
|
4.3%
11/256 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
1.8%
5/283 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
7.5%
77/1024 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
|
Gastrointestinal disorders
Constipation
|
3.5%
9/256 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
1.1%
3/283 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
6.5%
67/1024 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
|
General disorders
Application site pruritus
|
4.3%
11/256 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
6.7%
19/283 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
8.5%
87/1024 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
|
General disorders
Application site erythema
|
3.5%
9/256 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
4.9%
14/283 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
3.1%
32/1024 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
|
General disorders
Application site rash
|
4.7%
12/256 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
2.5%
7/283 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
1.8%
18/1024 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
|
Nervous system disorders
Dizziness
|
3.9%
10/256 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
1.1%
3/283 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
10.0%
102/1024 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
|
Nervous system disorders
Somnolence
|
1.6%
4/256 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
2.1%
6/283 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
8.2%
84/1024 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
|
Nervous system disorders
Headache
|
5.5%
14/256 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
4.9%
14/283 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
9.8%
100/1024 • Adverse Events (AEs) that occurred after the signing of the informed consent up to end of study and 7 days after, discontinuation, or Serious AEs occurring up to 30 days following the last study visit were followed until the AE resolved or stabilized.
AEs were obtained through spontaneous reports, subject interview, and subject diaries.
|
Additional Information
Clinical Leader, Medical Director
Purdue Pharma L.P.
Phone: 800-733-1333
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60