Trial Outcomes & Findings for Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Nonmalignant Pain (NCT NCT00312195)
NCT ID: NCT00312195
Last Updated: 2012-09-10
Results Overview
Ineffective treatment was defined as: * Subject took \>1 gram of acetaminophen in a 24-hour period, or * Subject required a change in transdermal patch (TDS) dose, or * Subject had difficulty in keeping the TDS on, or * Subject discontinued due to ineffective treatment (but did not meet any of the above criteria). Note: some subjects may have had multiple reasons for ineffective treatment and are counted under each category. Therefore the sum of subjects across all criteria for ineffective treatment is greater than the total number of subjects with ineffective treatment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
267 participants
Primary outcome timeframe
Double-blind phase (14 days)
Results posted on
2012-09-10
Participant Flow
(First patient first visit) 19-Mar-2001 to (last patient last visit) 22-Jul-2001 at 42 centers: 21 in the UK and 21 in the US.
The Run-in period (N = 588 subjects started) consisted of titration from buprenorphine transdermal patch (BTDS) 5 to BTDS 10, or 20 mcg/h for tolerability. If BTDS was not tolerated or pain increased, the subject was discontinued. N = 267 subjects were randomized.
Participant milestones
| Measure |
Double-blind Placebo Patch
Reference drug - Placebo transdermal patch to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear.
|
Double-blind BTDS
Test drug - buprenorphine transdermal patch (BTDS) 5, 10, or 20 mcg/h applied for 7-day wear.
|
|---|---|---|
|
Overall Study
STARTED
|
138
|
129
|
|
Overall Study
COMPLETED
|
132
|
123
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
Reasons for withdrawal
| Measure |
Double-blind Placebo Patch
Reference drug - Placebo transdermal patch to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear.
|
Double-blind BTDS
Test drug - buprenorphine transdermal patch (BTDS) 5, 10, or 20 mcg/h applied for 7-day wear.
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
6
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
Baseline Characteristics
Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Nonmalignant Pain
Baseline characteristics by cohort
| Measure |
Double-blind Placebo Patch
n=138 Participants
Reference drug - Placebo transdermal patch to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear.
|
Double-blind BTDS
n=129 Participants
Test drug - buprenorphine transdermal patch (BTDS) 5, 10, or 20 mcg/h applied for 7-day wear.
|
Total
n=267 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
59.2 years
STANDARD_DEVIATION 11.48 • n=5 Participants
|
56.2 years
STANDARD_DEVIATION 13.34 • n=7 Participants
|
57.7 years
STANDARD_DEVIATION 12.48 • n=5 Participants
|
|
Sex: Female, Male
Female
|
88 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
167 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
46 participants
n=5 Participants
|
42 participants
n=7 Participants
|
88 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
92 participants
n=5 Participants
|
87 participants
n=7 Participants
|
179 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Double-blind phase (14 days)Population: The Full Analysis Population (N = 266) for efficacy analyses included all subjects who were randomized and provided at least 1 efficacy assessment in the double-blind phase.
Ineffective treatment was defined as: * Subject took \>1 gram of acetaminophen in a 24-hour period, or * Subject required a change in transdermal patch (TDS) dose, or * Subject had difficulty in keeping the TDS on, or * Subject discontinued due to ineffective treatment (but did not meet any of the above criteria). Note: some subjects may have had multiple reasons for ineffective treatment and are counted under each category. Therefore the sum of subjects across all criteria for ineffective treatment is greater than the total number of subjects with ineffective treatment.
Outcome measures
| Measure |
Double-blind Placebo Patch
n=137 Participants
Reference drug - Placebo transdermal patch to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear.
|
Double-blind BTDS
n=129 Participants
Test drug - buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear.
|
Total
n=266 Participants
Placebo and BTDS combined.
|
|---|---|---|---|
|
The Number of Subjects With Ineffective Treatment During the Double-blind Evaluation Phase.
Subjects With Ineffective Treatment
|
89 participants
|
66 participants
|
155 participants
|
|
The Number of Subjects With Ineffective Treatment During the Double-blind Evaluation Phase.
Reason: took more than 1 gram of acetaminophen/day
|
81 participants
|
59 participants
|
140 participants
|
|
The Number of Subjects With Ineffective Treatment During the Double-blind Evaluation Phase.
Reason: required a change in TDS dose
|
34 participants
|
25 participants
|
59 participants
|
|
The Number of Subjects With Ineffective Treatment During the Double-blind Evaluation Phase.
Reason: difficulty keeping patch on
|
6 participants
|
1 participants
|
7 participants
|
|
The Number of Subjects With Ineffective Treatment During the Double-blind Evaluation Phase.
Reason: discontinued due to ineffective treatment
|
2 participants
|
3 participants
|
5 participants
|
SECONDARY outcome
Timeframe: 14 daysPopulation: Full Analysis (N = 266) consisted of subjects who were randomized into the double-blind evaluation phase, were exposed to study drug, and provided at least 1 efficacy assessment during the double-blind evaluation phase.
The time of ineffective treatment was calculated as the earliest of the following: * The date the subject first took \>1 gram of acetaminophen, * The visit date when ineffective treatment was first determined, or * The date the last patch was removed.
Outcome measures
| Measure |
Double-blind Placebo Patch
n=137 Participants
Reference drug - Placebo transdermal patch to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear.
|
Double-blind BTDS
n=129 Participants
Test drug - buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear.
|
Total
Placebo and BTDS combined.
|
|---|---|---|---|
|
Time (Days) From the Initial Dose of Study Drug in the Double-blind Evaluation Phase to Ineffective Treatment
|
5.6 Days
Standard Error 0.44
|
7.4 Days
Standard Error 0.45
|
—
|
SECONDARY outcome
Timeframe: 14 daysPopulation: Full Analysis (N = 266) consisted of subjects who were randomized into the double-blind evaluation phase, were exposed to study drug, and provided at least 1 efficacy assessment during the double-blind evaluation phase.
Note: The total numbers of "Subjects w/ineffective treatment or who discont'd" for placebo and BTDS are 1 less because there were reasons other than lack of efficacy that made up this total: adverse event, death, lost to follow- up, protocol violation, and other. Example for placebo 89+5=94; however, 93 is indicated for the total because there is 1 subject in the placebo group who was counted under ineffective treatment and discontinued due to reasons other than lack of efficacy. The same is true for 1 subject in BTDS.
Outcome measures
| Measure |
Double-blind Placebo Patch
n=137 Participants
Reference drug - Placebo transdermal patch to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear.
|
Double-blind BTDS
n=129 Participants
Test drug - buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear.
|
Total
Placebo and BTDS combined.
|
|---|---|---|---|
|
The Number of Subjects Who Had Ineffective Treatment or Who Discontinued Due to Reasons Other Than Ineffective Treatment in the Double-blind Phase
Subjects w/ineffective treatment or who discont'd
|
93 participants
|
71 participants
|
—
|
|
The Number of Subjects Who Had Ineffective Treatment or Who Discontinued Due to Reasons Other Than Ineffective Treatment in the Double-blind Phase
Ineffective Treatment
|
89 participants
|
66 participants
|
—
|
|
The Number of Subjects Who Had Ineffective Treatment or Who Discontinued Due to Reasons Other Than Ineffective Treatment in the Double-blind Phase
Discontinued due to other reasons
|
5 participants
|
6 participants
|
—
|
SECONDARY outcome
Timeframe: 14 daysPopulation: Full Analysis (N = 266) consisted of subjects who were randomized into the double-blind evaluation phase, were exposed to study drug, and provided at least 1 efficacy assessment during the double-blind evaluation phase.
The average daily acetaminophen (Panadol) use (1 tablet = 500 mg) during the double-blind phase was compared between the treatment groups using ANCOVA methodology with terms for country and treatment. The average escape medication used in the last 4 days prior to randomization was included as a covariate.
Outcome measures
| Measure |
Double-blind Placebo Patch
n=137 Participants
Reference drug - Placebo transdermal patch to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear.
|
Double-blind BTDS
n=129 Participants
Test drug - buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear.
|
Total
Placebo and BTDS combined.
|
|---|---|---|---|
|
The Amount of Rescue Medication Used for Pain (Average Daily Number of Acetaminophen Tablets).
|
2.2 Tablets
Standard Error 0.15
|
1.8 Tablets
Standard Error 0.14
|
—
|
Adverse Events
Double-blind Placebo Patch
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Double-blind BTDS
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Open-label Run-in Period BTDS 5, 10 or 20
Serious events: 7 serious events
Other events: 245 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Double-blind Placebo Patch
n=138 participants at risk
Reference drug - Placebo transdermal patch to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear.
|
Double-blind BTDS
n=129 participants at risk
Test drug - buprenorphine transdermal patch (BTDS) 5, 10, or 20 mcg/h applied for 7-day wear.
|
Open-label Run-in Period BTDS 5, 10 or 20
n=588 participants at risk
Buprenorphine transdermal patch (BTDS) 5, 10, or 20 mcg/h applied for 7-day wear.
|
|---|---|---|---|
|
General disorders
Pain abdominal
|
0.00%
0/138 • Adverse Events (AEs)that occurred after the signing of the informed consent up to end of study, discontinuation, or Serious AE occurring up to 30 days following the last study visit were followed until the AE resolved.
Adverse Events were learned of through spontaneous reports and subject interview.
|
0.00%
0/129 • Adverse Events (AEs)that occurred after the signing of the informed consent up to end of study, discontinuation, or Serious AE occurring up to 30 days following the last study visit were followed until the AE resolved.
Adverse Events were learned of through spontaneous reports and subject interview.
|
0.17%
1/588 • Number of events 1 • Adverse Events (AEs)that occurred after the signing of the informed consent up to end of study, discontinuation, or Serious AE occurring up to 30 days following the last study visit were followed until the AE resolved.
Adverse Events were learned of through spontaneous reports and subject interview.
|
|
General disorders
Abscess
|
0.00%
0/138 • Adverse Events (AEs)that occurred after the signing of the informed consent up to end of study, discontinuation, or Serious AE occurring up to 30 days following the last study visit were followed until the AE resolved.
Adverse Events were learned of through spontaneous reports and subject interview.
|
0.00%
0/129 • Adverse Events (AEs)that occurred after the signing of the informed consent up to end of study, discontinuation, or Serious AE occurring up to 30 days following the last study visit were followed until the AE resolved.
Adverse Events were learned of through spontaneous reports and subject interview.
|
0.17%
1/588 • Number of events 1 • Adverse Events (AEs)that occurred after the signing of the informed consent up to end of study, discontinuation, or Serious AE occurring up to 30 days following the last study visit were followed until the AE resolved.
Adverse Events were learned of through spontaneous reports and subject interview.
|
|
General disorders
Injury accidental
|
0.00%
0/138 • Adverse Events (AEs)that occurred after the signing of the informed consent up to end of study, discontinuation, or Serious AE occurring up to 30 days following the last study visit were followed until the AE resolved.
Adverse Events were learned of through spontaneous reports and subject interview.
|
0.00%
0/129 • Adverse Events (AEs)that occurred after the signing of the informed consent up to end of study, discontinuation, or Serious AE occurring up to 30 days following the last study visit were followed until the AE resolved.
Adverse Events were learned of through spontaneous reports and subject interview.
|
0.17%
1/588 • Number of events 1 • Adverse Events (AEs)that occurred after the signing of the informed consent up to end of study, discontinuation, or Serious AE occurring up to 30 days following the last study visit were followed until the AE resolved.
Adverse Events were learned of through spontaneous reports and subject interview.
|
|
General disorders
Cellulitis
|
0.00%
0/138 • Adverse Events (AEs)that occurred after the signing of the informed consent up to end of study, discontinuation, or Serious AE occurring up to 30 days following the last study visit were followed until the AE resolved.
Adverse Events were learned of through spontaneous reports and subject interview.
|
0.00%
0/129 • Adverse Events (AEs)that occurred after the signing of the informed consent up to end of study, discontinuation, or Serious AE occurring up to 30 days following the last study visit were followed until the AE resolved.
Adverse Events were learned of through spontaneous reports and subject interview.
|
0.17%
1/588 • Number of events 1 • Adverse Events (AEs)that occurred after the signing of the informed consent up to end of study, discontinuation, or Serious AE occurring up to 30 days following the last study visit were followed until the AE resolved.
Adverse Events were learned of through spontaneous reports and subject interview.
|
|
General disorders
Pain, chest
|
0.00%
0/138 • Adverse Events (AEs)that occurred after the signing of the informed consent up to end of study, discontinuation, or Serious AE occurring up to 30 days following the last study visit were followed until the AE resolved.
Adverse Events were learned of through spontaneous reports and subject interview.
|
0.00%
0/129 • Adverse Events (AEs)that occurred after the signing of the informed consent up to end of study, discontinuation, or Serious AE occurring up to 30 days following the last study visit were followed until the AE resolved.
Adverse Events were learned of through spontaneous reports and subject interview.
|
0.17%
1/588 • Number of events 1 • Adverse Events (AEs)that occurred after the signing of the informed consent up to end of study, discontinuation, or Serious AE occurring up to 30 days following the last study visit were followed until the AE resolved.
Adverse Events were learned of through spontaneous reports and subject interview.
|
|
Cardiac disorders
Fibrillation, atrial
|
0.00%
0/138 • Adverse Events (AEs)that occurred after the signing of the informed consent up to end of study, discontinuation, or Serious AE occurring up to 30 days following the last study visit were followed until the AE resolved.
Adverse Events were learned of through spontaneous reports and subject interview.
|
0.00%
0/129 • Adverse Events (AEs)that occurred after the signing of the informed consent up to end of study, discontinuation, or Serious AE occurring up to 30 days following the last study visit were followed until the AE resolved.
Adverse Events were learned of through spontaneous reports and subject interview.
|
0.17%
1/588 • Number of events 1 • Adverse Events (AEs)that occurred after the signing of the informed consent up to end of study, discontinuation, or Serious AE occurring up to 30 days following the last study visit were followed until the AE resolved.
Adverse Events were learned of through spontaneous reports and subject interview.
|
|
Immune system disorders
Gastroenteritis
|
0.00%
0/138 • Adverse Events (AEs)that occurred after the signing of the informed consent up to end of study, discontinuation, or Serious AE occurring up to 30 days following the last study visit were followed until the AE resolved.
Adverse Events were learned of through spontaneous reports and subject interview.
|
0.00%
0/129 • Adverse Events (AEs)that occurred after the signing of the informed consent up to end of study, discontinuation, or Serious AE occurring up to 30 days following the last study visit were followed until the AE resolved.
Adverse Events were learned of through spontaneous reports and subject interview.
|
0.17%
1/588 • Number of events 1 • Adverse Events (AEs)that occurred after the signing of the informed consent up to end of study, discontinuation, or Serious AE occurring up to 30 days following the last study visit were followed until the AE resolved.
Adverse Events were learned of through spontaneous reports and subject interview.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/138 • Adverse Events (AEs)that occurred after the signing of the informed consent up to end of study, discontinuation, or Serious AE occurring up to 30 days following the last study visit were followed until the AE resolved.
Adverse Events were learned of through spontaneous reports and subject interview.
|
0.00%
0/129 • Adverse Events (AEs)that occurred after the signing of the informed consent up to end of study, discontinuation, or Serious AE occurring up to 30 days following the last study visit were followed until the AE resolved.
Adverse Events were learned of through spontaneous reports and subject interview.
|
0.34%
2/588 • Number of events 2 • Adverse Events (AEs)that occurred after the signing of the informed consent up to end of study, discontinuation, or Serious AE occurring up to 30 days following the last study visit were followed until the AE resolved.
Adverse Events were learned of through spontaneous reports and subject interview.
|
|
Nervous system disorders
Depression
|
0.00%
0/138 • Adverse Events (AEs)that occurred after the signing of the informed consent up to end of study, discontinuation, or Serious AE occurring up to 30 days following the last study visit were followed until the AE resolved.
Adverse Events were learned of through spontaneous reports and subject interview.
|
0.00%
0/129 • Adverse Events (AEs)that occurred after the signing of the informed consent up to end of study, discontinuation, or Serious AE occurring up to 30 days following the last study visit were followed until the AE resolved.
Adverse Events were learned of through spontaneous reports and subject interview.
|
0.17%
1/588 • Number of events 1 • Adverse Events (AEs)that occurred after the signing of the informed consent up to end of study, discontinuation, or Serious AE occurring up to 30 days following the last study visit were followed until the AE resolved.
Adverse Events were learned of through spontaneous reports and subject interview.
|
Other adverse events
| Measure |
Double-blind Placebo Patch
n=138 participants at risk
Reference drug - Placebo transdermal patch to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear.
|
Double-blind BTDS
n=129 participants at risk
Test drug - buprenorphine transdermal patch (BTDS) 5, 10, or 20 mcg/h applied for 7-day wear.
|
Open-label Run-in Period BTDS 5, 10 or 20
n=588 participants at risk
Buprenorphine transdermal patch (BTDS) 5, 10, or 20 mcg/h applied for 7-day wear.
|
|---|---|---|---|
|
General disorders
Headache
|
2.2%
3/138 • Adverse Events (AEs)that occurred after the signing of the informed consent up to end of study, discontinuation, or Serious AE occurring up to 30 days following the last study visit were followed until the AE resolved.
Adverse Events were learned of through spontaneous reports and subject interview.
|
3.9%
5/129 • Adverse Events (AEs)that occurred after the signing of the informed consent up to end of study, discontinuation, or Serious AE occurring up to 30 days following the last study visit were followed until the AE resolved.
Adverse Events were learned of through spontaneous reports and subject interview.
|
7.5%
44/588 • Adverse Events (AEs)that occurred after the signing of the informed consent up to end of study, discontinuation, or Serious AE occurring up to 30 days following the last study visit were followed until the AE resolved.
Adverse Events were learned of through spontaneous reports and subject interview.
|
|
General disorders
Asthenia
|
2.2%
3/138 • Adverse Events (AEs)that occurred after the signing of the informed consent up to end of study, discontinuation, or Serious AE occurring up to 30 days following the last study visit were followed until the AE resolved.
Adverse Events were learned of through spontaneous reports and subject interview.
|
1.6%
2/129 • Adverse Events (AEs)that occurred after the signing of the informed consent up to end of study, discontinuation, or Serious AE occurring up to 30 days following the last study visit were followed until the AE resolved.
Adverse Events were learned of through spontaneous reports and subject interview.
|
6.1%
36/588 • Adverse Events (AEs)that occurred after the signing of the informed consent up to end of study, discontinuation, or Serious AE occurring up to 30 days following the last study visit were followed until the AE resolved.
Adverse Events were learned of through spontaneous reports and subject interview.
|
|
Gastrointestinal disorders
Nausea
|
3.6%
5/138 • Adverse Events (AEs)that occurred after the signing of the informed consent up to end of study, discontinuation, or Serious AE occurring up to 30 days following the last study visit were followed until the AE resolved.
Adverse Events were learned of through spontaneous reports and subject interview.
|
3.1%
4/129 • Adverse Events (AEs)that occurred after the signing of the informed consent up to end of study, discontinuation, or Serious AE occurring up to 30 days following the last study visit were followed until the AE resolved.
Adverse Events were learned of through spontaneous reports and subject interview.
|
19.0%
112/588 • Adverse Events (AEs)that occurred after the signing of the informed consent up to end of study, discontinuation, or Serious AE occurring up to 30 days following the last study visit were followed until the AE resolved.
Adverse Events were learned of through spontaneous reports and subject interview.
|
|
Gastrointestinal disorders
Vomit
|
0.00%
0/138 • Adverse Events (AEs)that occurred after the signing of the informed consent up to end of study, discontinuation, or Serious AE occurring up to 30 days following the last study visit were followed until the AE resolved.
Adverse Events were learned of through spontaneous reports and subject interview.
|
0.78%
1/129 • Adverse Events (AEs)that occurred after the signing of the informed consent up to end of study, discontinuation, or Serious AE occurring up to 30 days following the last study visit were followed until the AE resolved.
Adverse Events were learned of through spontaneous reports and subject interview.
|
6.1%
36/588 • Adverse Events (AEs)that occurred after the signing of the informed consent up to end of study, discontinuation, or Serious AE occurring up to 30 days following the last study visit were followed until the AE resolved.
Adverse Events were learned of through spontaneous reports and subject interview.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/138 • Adverse Events (AEs)that occurred after the signing of the informed consent up to end of study, discontinuation, or Serious AE occurring up to 30 days following the last study visit were followed until the AE resolved.
Adverse Events were learned of through spontaneous reports and subject interview.
|
0.00%
0/129 • Adverse Events (AEs)that occurred after the signing of the informed consent up to end of study, discontinuation, or Serious AE occurring up to 30 days following the last study visit were followed until the AE resolved.
Adverse Events were learned of through spontaneous reports and subject interview.
|
12.4%
73/588 • Adverse Events (AEs)that occurred after the signing of the informed consent up to end of study, discontinuation, or Serious AE occurring up to 30 days following the last study visit were followed until the AE resolved.
Adverse Events were learned of through spontaneous reports and subject interview.
|
|
Nervous system disorders
Somnolence
|
0.72%
1/138 • Adverse Events (AEs)that occurred after the signing of the informed consent up to end of study, discontinuation, or Serious AE occurring up to 30 days following the last study visit were followed until the AE resolved.
Adverse Events were learned of through spontaneous reports and subject interview.
|
2.3%
3/129 • Adverse Events (AEs)that occurred after the signing of the informed consent up to end of study, discontinuation, or Serious AE occurring up to 30 days following the last study visit were followed until the AE resolved.
Adverse Events were learned of through spontaneous reports and subject interview.
|
7.0%
41/588 • Adverse Events (AEs)that occurred after the signing of the informed consent up to end of study, discontinuation, or Serious AE occurring up to 30 days following the last study visit were followed until the AE resolved.
Adverse Events were learned of through spontaneous reports and subject interview.
|
|
Skin and subcutaneous tissue disorders
Erythema at site
|
13.0%
18/138 • Adverse Events (AEs)that occurred after the signing of the informed consent up to end of study, discontinuation, or Serious AE occurring up to 30 days following the last study visit were followed until the AE resolved.
Adverse Events were learned of through spontaneous reports and subject interview.
|
13.2%
17/129 • Adverse Events (AEs)that occurred after the signing of the informed consent up to end of study, discontinuation, or Serious AE occurring up to 30 days following the last study visit were followed until the AE resolved.
Adverse Events were learned of through spontaneous reports and subject interview.
|
7.3%
43/588 • Adverse Events (AEs)that occurred after the signing of the informed consent up to end of study, discontinuation, or Serious AE occurring up to 30 days following the last study visit were followed until the AE resolved.
Adverse Events were learned of through spontaneous reports and subject interview.
|
|
Skin and subcutaneous tissue disorders
Pruritus at site
|
5.1%
7/138 • Adverse Events (AEs)that occurred after the signing of the informed consent up to end of study, discontinuation, or Serious AE occurring up to 30 days following the last study visit were followed until the AE resolved.
Adverse Events were learned of through spontaneous reports and subject interview.
|
9.3%
12/129 • Adverse Events (AEs)that occurred after the signing of the informed consent up to end of study, discontinuation, or Serious AE occurring up to 30 days following the last study visit were followed until the AE resolved.
Adverse Events were learned of through spontaneous reports and subject interview.
|
9.9%
58/588 • Adverse Events (AEs)that occurred after the signing of the informed consent up to end of study, discontinuation, or Serious AE occurring up to 30 days following the last study visit were followed until the AE resolved.
Adverse Events were learned of through spontaneous reports and subject interview.
|
Additional Information
Clinical Leader, Executive 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