Trial Outcomes & Findings for Buprenorphine Transdermal Patches (BTDS) in Subjects With Osteoarthritis Pain. Includes a 52-week Extension Phase. (NCT NCT00320801)
NCT ID: NCT00320801
Last Updated: 2012-09-03
Results Overview
Safety assessments included monitoring and recording of all adverse events and serious adverse events (SAEs).
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
188 participants
Primary outcome timeframe
Throughout BTDS exposure (Includes run-in period, double-blind phase and extension phase)
Results posted on
2012-09-03
Participant Flow
07-Jan-2004 (First subject first visit); 09-Mar-2005 (last subject last visit of extension \[subjects went directly into the extension upon completion of the double-blind phase\]) at 42 sites in the United States (US).
Adult subjects (≥ 40 years), with osteoarthritis (OA) of the hip, knee or spine for longer than 1 year, controlled on oral opioid therapy, who met the inclusion/exclusion criteria specified in the protocol. The open-label run-in period (N = 188) selected subjects who tolerated BTDS 20 mcg/h and showed stable pain control (N = 96 completed).
Participant milestones
| Measure |
Run-in Period
(≤14 days). The run-in period was designed to select subjects who tolerated and responded to BTDS 20. Subjects were eligible to enter the double-blind phase if they tolerated BTDS 20 and achieved stable analgesia.
|
Double-blind BTDS 5
Reference treatment: Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
|
Double-blind BTDS 20
Test treatment: buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
|
Extension Phase
Subjects received open-label buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear for up to 52 weeks.
|
|---|---|---|---|---|
|
Open-label Run-in Period
STARTED
|
188
|
0
|
0
|
0
|
|
Open-label Run-in Period
COMPLETED
|
96
|
0
|
0
|
0
|
|
Open-label Run-in Period
NOT COMPLETED
|
92
|
0
|
0
|
0
|
|
Double-blind Phase
STARTED
|
0
|
47
|
49
|
0
|
|
Double-blind Phase
COMPLETED
|
0
|
36
|
35
|
0
|
|
Double-blind Phase
NOT COMPLETED
|
0
|
11
|
14
|
0
|
|
Extension Phase
STARTED
|
0
|
0
|
0
|
55
|
|
Extension Phase
COMPLETED
|
0
|
0
|
0
|
7
|
|
Extension Phase
NOT COMPLETED
|
0
|
0
|
0
|
48
|
Reasons for withdrawal
| Measure |
Run-in Period
(≤14 days). The run-in period was designed to select subjects who tolerated and responded to BTDS 20. Subjects were eligible to enter the double-blind phase if they tolerated BTDS 20 and achieved stable analgesia.
|
Double-blind BTDS 5
Reference treatment: Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
|
Double-blind BTDS 20
Test treatment: buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
|
Extension Phase
Subjects received open-label buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear for up to 52 weeks.
|
|---|---|---|---|---|
|
Open-label Run-in Period
Withdrawal by Subject
|
2
|
0
|
0
|
0
|
|
Open-label Run-in Period
Adverse Event
|
33
|
0
|
0
|
0
|
|
Open-label Run-in Period
Administrative
|
10
|
0
|
0
|
0
|
|
Open-label Run-in Period
Lack of Efficacy
|
44
|
0
|
0
|
0
|
|
Open-label Run-in Period
Lost to Follow-up
|
2
|
0
|
0
|
0
|
|
Open-label Run-in Period
Did not qualify
|
1
|
0
|
0
|
0
|
|
Double-blind Phase
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
|
Double-blind Phase
Adverse Event
|
0
|
2
|
8
|
0
|
|
Double-blind Phase
Administrative
|
0
|
0
|
4
|
0
|
|
Double-blind Phase
Lack of Efficacy
|
0
|
9
|
1
|
0
|
|
Extension Phase
Withdrawal by Subject
|
0
|
0
|
0
|
6
|
|
Extension Phase
Adverse Event
|
0
|
0
|
0
|
8
|
|
Extension Phase
Administrative
|
0
|
0
|
0
|
29
|
|
Extension Phase
Lack of Efficacy
|
0
|
0
|
0
|
2
|
|
Extension Phase
Lost to Follow-up
|
0
|
0
|
0
|
3
|
Baseline Characteristics
Buprenorphine Transdermal Patches (BTDS) in Subjects With Osteoarthritis Pain. Includes a 52-week Extension Phase.
Baseline characteristics by cohort
| Measure |
Double-blind BTDS 5
n=47 Participants
Reference treatment: Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
|
Double-blind BTDS 20
n=49 Participants
Test treatment: Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
58.1 years
STANDARD_DEVIATION 11.65 • n=5 Participants
|
61.1 years
STANDARD_DEVIATION 11.72 • n=7 Participants
|
59.6 years
STANDARD_DEVIATION 11.72 • n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Throughout BTDS exposure (Includes run-in period, double-blind phase and extension phase)Population: The safety population consists of all subjects who received at least 1 dose of study drug and had at least 1 safety assessment after the initial dose of BTDS in the study.
Safety assessments included monitoring and recording of all adverse events and serious adverse events (SAEs).
Outcome measures
| Measure |
Double-blind BTDS 5
n=47 Participants
Reference treatment: Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
|
Double-blind BTDS 20
n=49 Participants
Test treatment: Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
|
Run-in Period
n=188 Participants
The run-in period was designed to determine tolerability of BTDS 20. Subjects were eligible to enter the double-blind phase if they tolerated BTDS 20 and achieved stable analgesia.
|
Overall BTDS Exposure
n=188 Participants
Overall core and extension phase combined (run-in period, double-blind phase, and extension phase)
|
|---|---|---|---|---|
|
The Number of Participants With Adverse Events (AEs) as a Measure of Safety.
Deaths
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Participants With Adverse Events (AEs) as a Measure of Safety.
Serious adverse events
|
1 Participants
|
1 Participants
|
2 Participants
|
6 Participants
|
|
The Number of Participants With Adverse Events (AEs) as a Measure of Safety.
Other Adverse Events in ≥ 4.5% of subjects
|
17 Participants
|
22 Participants
|
52 Participants
|
101 Participants
|
Adverse Events
Double-blind BTDS 5
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Double-blind BTDS 20
Serious events: 1 serious events
Other events: 22 other events
Deaths: 0 deaths
Open-label Run-in Period
Serious events: 2 serious events
Other events: 52 other events
Deaths: 0 deaths
Overall BTDS Exposure
Serious events: 6 serious events
Other events: 101 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Double-blind BTDS 5
n=47 participants at risk
Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
|
Double-blind BTDS 20
n=49 participants at risk
Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
|
Open-label Run-in Period
n=188 participants at risk
The run-in period (14 days) was designed to identify subjects whose pain was controlled with and who tolerated BTDS 20. Open-label BTDS 10 or 20 mcg/h applied for 7-day wear to qualify for randomization into the double-blind phase.
|
Overall BTDS Exposure
n=188 participants at risk
Overall core and extension phase combined (run-in period, double-blind phase, and extension phase)
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/47 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/49 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
1.1%
2/188 • Number of events 2 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
1.1%
2/188 • Number of events 2 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
|
General disorders
Chest pain
|
0.00%
0/47 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/49 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.53%
1/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.53%
1/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
|
General disorders
Chest pressure
|
0.00%
0/47 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/49 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.53%
1/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.53%
1/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/47 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/49 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.53%
1/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.53%
1/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/47 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/49 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.53%
1/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.53%
1/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
|
Nervous system disorders
Headache
|
0.00%
0/47 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/49 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.53%
1/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.53%
1/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
|
Nervous system disorders
Somnolent
|
0.00%
0/47 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/49 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.53%
1/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.53%
1/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
|
Nervous system disorders
Worsening of reflex sympathetic dystrophy
|
2.1%
1/47 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/49 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.53%
1/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
|
Renal and urinary disorders
Kidney stone
|
0.00%
0/47 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
2.0%
1/49 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.53%
1/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
0.00%
0/47 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/49 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.53%
1/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.53%
1/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
|
Skin and subcutaneous tissue disorders
Diaphoresis
|
0.00%
0/47 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/49 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.53%
1/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.53%
1/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
|
Injury, poisoning and procedural complications
Grade 2 splenic laceration
|
0.00%
0/47 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/49 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.53%
1/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
|
Injury, poisoning and procedural complications
Right occipital condyle fracture
|
0.00%
0/47 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/49 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.53%
1/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
|
Injury, poisoning and procedural complications
Comminuted pelvic fracture left
|
0.00%
0/47 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/49 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.53%
1/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
|
Injury, poisoning and procedural complications
Right tibia-fibula fracture
|
0.00%
0/47 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/49 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.53%
1/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
|
Injury, poisoning and procedural complications
Sphenoid fracture
|
0.00%
0/47 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/49 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.53%
1/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
|
Injury, poisoning and procedural complications
Comminuted acetabulum left
|
0.00%
0/47 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/49 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.53%
1/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
|
Injury, poisoning and procedural complications
Right lower lobe contusion on chest
|
0.00%
0/47 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/49 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.53%
1/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
|
Injury, poisoning and procedural complications
Left post distal shaft fibular fracture
|
0.00%
0/47 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/49 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.53%
1/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
|
Injury, poisoning and procedural complications
Left lower lobe contusion
|
0.00%
0/47 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/49 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.53%
1/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
|
Injury, poisoning and procedural complications
Subarachnoid hemorrhage of fourth ventricle
|
0.00%
0/47 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/49 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.53%
1/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
|
Injury, poisoning and procedural complications
Left hip fracture
|
0.00%
0/47 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/49 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.53%
1/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
|
Hepatobiliary disorders
Acute cholecystitis
|
0.00%
0/47 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/49 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.53%
1/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
Other adverse events
| Measure |
Double-blind BTDS 5
n=47 participants at risk
Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
|
Double-blind BTDS 20
n=49 participants at risk
Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
|
Open-label Run-in Period
n=188 participants at risk
The run-in period (14 days) was designed to identify subjects whose pain was controlled with and who tolerated BTDS 20. Open-label BTDS 10 or 20 mcg/h applied for 7-day wear to qualify for randomization into the double-blind phase.
|
Overall BTDS Exposure
n=188 participants at risk
Overall core and extension phase combined (run-in period, double-blind phase, and extension phase)
|
|---|---|---|---|---|
|
General disorders
Application site pruritus
|
6.4%
3/47 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
10.2%
5/49 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
4.8%
9/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
9.0%
17/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
|
Gastrointestinal disorders
Nausea
|
8.5%
4/47 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
6.1%
3/49 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
16.0%
30/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
20.2%
38/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
|
Gastrointestinal disorders
Vomiting NOS
|
2.1%
1/47 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
4.1%
2/49 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
8.5%
16/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
11.2%
21/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
|
Gastrointestinal disorders
Constipation
|
2.1%
1/47 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
10.2%
5/49 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
2.1%
4/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
4.8%
9/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
|
General disorders
Edema peripheral
|
8.5%
4/47 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
8.2%
4/49 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
2.7%
5/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
9.6%
18/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
|
General disorders
Application site erythema
|
6.4%
3/47 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
10.2%
5/49 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
2.1%
4/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
7.4%
14/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.1%
1/47 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
12.2%
6/49 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
1.6%
3/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
8.5%
16/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.4%
3/47 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/49 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
2.1%
4/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
|
Nervous system disorders
Headache
|
8.5%
4/47 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
4.1%
2/49 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
8.5%
16/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
12.8%
24/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
|
Nervous system disorders
Dizziness
|
4.3%
2/47 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
2.0%
1/49 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
8.0%
15/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
10.6%
20/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
|
Psychiatric disorders
Anxiety
|
6.4%
3/47 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.00%
0/49 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
0.53%
1/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
2.7%
5/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
|
General disorders
Application site rash
|
4.3%
2/47 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
2.0%
1/49 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
3.7%
7/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
8.0%
15/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
|
Musculoskeletal and connective tissue disorders
Pain in limb
|
2.1%
1/47 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
4.1%
2/49 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
2.1%
4/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
5.9%
11/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
|
Nervous system disorders
Somnolence
|
4.3%
2/47 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
4.1%
2/49 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
3.2%
6/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
5.3%
10/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/47 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
2.0%
1/49 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
4.3%
8/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
4.8%
9/188 • 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 learned of by spontaneous reports, subject interview, and daily diary.
|
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