Trial Outcomes & Findings for Safety of Buprenorphine Transdermal Systems in Subjects With Chronic Nonmalignant Pain - a 28-week Extension Study (NCT NCT01151098)
NCT ID: NCT01151098
Last Updated: 2012-09-10
Results Overview
Safety was assessed using reports of all new adverse events (AEs) that occurred after the first application of a patch during the extension phase were recorded.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
189 participants
Primary outcome timeframe
28 weeks
Results posted on
2012-09-10
Participant Flow
16-Apr-2001 (first patient first visit) 27-Feb-2002 (last patient last visit). The extension phase of study was conducted at 20 sites in the US Baseline Period: and 18 sites in the UK.
Adult subjects aged ≥ 18 years, with chronic nonmalignant pain, controlled on oral opioid therapy. Subjects in the US who participated in the BUP3201 core study and met the criteria per Amendment 2, and subjects in the UK who participated in the BUP3201 core and met the inclusion/ exclusion criteria, were able to participate in the extension.
Participant milestones
| Measure |
Total Extension Phase
Buprenorphine transdermal patches (BTDS 5, 10 or 20) applied for 7-day wear.
|
|---|---|
|
Overall Study
STARTED
|
189
|
|
Overall Study
COMPLETED
|
72
|
|
Overall Study
NOT COMPLETED
|
117
|
Reasons for withdrawal
| Measure |
Total Extension Phase
Buprenorphine transdermal patches (BTDS 5, 10 or 20) applied for 7-day wear.
|
|---|---|
|
Overall Study
Adverse Event
|
82
|
|
Overall Study
Lost to Follow-up
|
6
|
|
Overall Study
Lack of Efficacy
|
15
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Miscellaneous
|
13
|
Baseline Characteristics
Safety of Buprenorphine Transdermal Systems in Subjects With Chronic Nonmalignant Pain - a 28-week Extension Study
Baseline characteristics by cohort
| Measure |
Extension Phase (BTDS 5, 10 or 20)
n=189 Participants
Buprenorphine transdermal patches (BTDS 5, 10 or 20) applied for 7-day wear.
|
|---|---|
|
Region of Enrollment
United Kingdom
|
86 participants
n=5 Participants
|
|
Age Continuous
|
55.2 years
STANDARD_DEVIATION 12.84 • n=5 Participants
|
|
Sex: Female, Male
Female
|
118 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
71 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
103 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 weeksPopulation: The Extension Safety population (N = 189) includes all subjects who were exposed to BTDS during the Open-label Extension Phase and provided at least 1 valid safety assessment after exposure to BTDS during the Open-label Extension Phase.
Safety was assessed using reports of all new adverse events (AEs) that occurred after the first application of a patch during the extension phase were recorded.
Outcome measures
| Measure |
Total Extension Phase
n=189 Participants
Buprenorphine transdermal patches (BTDS 5, 10, or 20) applied for 7-day wear.
|
|---|---|
|
Number of Participants With Adverse Events (AEs) as a Measure of Safety.
Serious Adverse Events
|
16 participants
|
|
Number of Participants With Adverse Events (AEs) as a Measure of Safety.
Deaths
|
1 participants
|
|
Number of Participants With Adverse Events (AEs) as a Measure of Safety.
All Other Adverse Events in ≥ 4.5% of Subjects
|
143 participants
|
Adverse Events
Total Extension Phase
Serious events: 16 serious events
Other events: 143 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Total Extension Phase
n=189 participants at risk
Buprenorphine transdermal patches (BTDS 5, 10 or 20) applied for 7-day wear.
|
|---|---|
|
General disorders
Abdominal pain
|
0.53%
1/189 • Number of events 1 • All adverse events that occurred after administration of the first dose of study drug on or before the final visit were reported and up to 30 days after the end of the trial.
Adverse Events were obtained through spontaneous reports and subject interview.
|
|
General disorders
Asthenia
|
0.53%
1/189 • Number of events 1 • All adverse events that occurred after administration of the first dose of study drug on or before the final visit were reported and up to 30 days after the end of the trial.
Adverse Events were obtained through spontaneous reports and subject interview.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.53%
1/189 • Number of events 1 • All adverse events that occurred after administration of the first dose of study drug on or before the final visit were reported and up to 30 days after the end of the trial.
Adverse Events were obtained through spontaneous reports and subject interview.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoma
|
0.53%
1/189 • Number of events 1 • All adverse events that occurred after administration of the first dose of study drug on or before the final visit were reported and up to 30 days after the end of the trial.
Adverse Events were obtained through spontaneous reports and subject interview.
|
|
Musculoskeletal and connective tissue disorders
Hernia
|
0.53%
1/189 • Number of events 1 • All adverse events that occurred after administration of the first dose of study drug on or before the final visit were reported and up to 30 days after the end of the trial.
Adverse Events were obtained through spontaneous reports and subject interview.
|
|
Vascular disorders
Vascular disorder
|
1.1%
2/189 • Number of events 2 • All adverse events that occurred after administration of the first dose of study drug on or before the final visit were reported and up to 30 days after the end of the trial.
Adverse Events were obtained through spontaneous reports and subject interview.
|
|
Cardiac disorders
Cardiovascular disorder
|
0.53%
1/189 • Number of events 2 • All adverse events that occurred after administration of the first dose of study drug on or before the final visit were reported and up to 30 days after the end of the trial.
Adverse Events were obtained through spontaneous reports and subject interview.
|
|
Cardiac disorders
Congestive heart failure
|
0.53%
1/189 • Number of events 1 • All adverse events that occurred after administration of the first dose of study drug on or before the final visit were reported and up to 30 days after the end of the trial.
Adverse Events were obtained through spontaneous reports and subject interview.
|
|
Cardiac disorders
Myocardial infarct
|
0.53%
1/189 • Number of events 1 • All adverse events that occurred after administration of the first dose of study drug on or before the final visit were reported and up to 30 days after the end of the trial.
Adverse Events were obtained through spontaneous reports and subject interview.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.53%
1/189 • Number of events 1 • All adverse events that occurred after administration of the first dose of study drug on or before the final visit were reported and up to 30 days after the end of the trial.
Adverse Events were obtained through spontaneous reports and subject interview.
|
|
Gastrointestinal disorders
Diarrhea
|
0.53%
1/189 • Number of events 1 • All adverse events that occurred after administration of the first dose of study drug on or before the final visit were reported and up to 30 days after the end of the trial.
Adverse Events were obtained through spontaneous reports and subject interview.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.53%
1/189 • Number of events 1 • All adverse events that occurred after administration of the first dose of study drug on or before the final visit were reported and up to 30 days after the end of the trial.
Adverse Events were obtained through spontaneous reports and subject interview.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma-like reaction
|
0.53%
1/189 • Number of events 1 • All adverse events that occurred after administration of the first dose of study drug on or before the final visit were reported and up to 30 days after the end of the trial.
Adverse Events were obtained through spontaneous reports and subject interview.
|
|
Metabolism and nutrition disorders
Cachexia - Death
|
0.53%
1/189 • Number of events 1 • All adverse events that occurred after administration of the first dose of study drug on or before the final visit were reported and up to 30 days after the end of the trial.
Adverse Events were obtained through spontaneous reports and subject interview.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.53%
1/189 • Number of events 1 • All adverse events that occurred after administration of the first dose of study drug on or before the final visit were reported and up to 30 days after the end of the trial.
Adverse Events were obtained through spontaneous reports and subject interview.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.53%
1/189 • Number of events 1 • All adverse events that occurred after administration of the first dose of study drug on or before the final visit were reported and up to 30 days after the end of the trial.
Adverse Events were obtained through spontaneous reports and subject interview.
|
|
Musculoskeletal and connective tissue disorders
Joint disorder
|
0.53%
1/189 • Number of events 1 • All adverse events that occurred after administration of the first dose of study drug on or before the final visit were reported and up to 30 days after the end of the trial.
Adverse Events were obtained through spontaneous reports and subject interview.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.53%
1/189 • Number of events 1 • All adverse events that occurred after administration of the first dose of study drug on or before the final visit were reported and up to 30 days after the end of the trial.
Adverse Events were obtained through spontaneous reports and subject interview.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolus
|
0.53%
1/189 • Number of events 1 • All adverse events that occurred after administration of the first dose of study drug on or before the final visit were reported and up to 30 days after the end of the trial.
Adverse Events were obtained through spontaneous reports and subject interview.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian carcinoma
|
0.53%
1/189 • Number of events 1 • All adverse events that occurred after administration of the first dose of study drug on or before the final visit were reported and up to 30 days after the end of the trial.
Adverse Events were obtained through spontaneous reports and subject interview.
|
|
Renal and urinary disorders
Urinary retention
|
0.53%
1/189 • Number of events 1 • All adverse events that occurred after administration of the first dose of study drug on or before the final visit were reported and up to 30 days after the end of the trial.
Adverse Events were obtained through spontaneous reports and subject interview.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine fibroids enlarged
|
0.53%
1/189 • Number of events 1 • All adverse events that occurred after administration of the first dose of study drug on or before the final visit were reported and up to 30 days after the end of the trial.
Adverse Events were obtained through spontaneous reports and subject interview.
|
Other adverse events
| Measure |
Total Extension Phase
n=189 participants at risk
Buprenorphine transdermal patches (BTDS 5, 10 or 20) applied for 7-day wear.
|
|---|---|
|
Infections and infestations
Infection
|
8.5%
16/189 • All adverse events that occurred after administration of the first dose of study drug on or before the final visit were reported and up to 30 days after the end of the trial.
Adverse Events were obtained through spontaneous reports and subject interview.
|
|
General disorders
Pain
|
8.5%
16/189 • All adverse events that occurred after administration of the first dose of study drug on or before the final visit were reported and up to 30 days after the end of the trial.
Adverse Events were obtained through spontaneous reports and subject interview.
|
|
Injury, poisoning and procedural complications
Accidental injury
|
6.3%
12/189 • All adverse events that occurred after administration of the first dose of study drug on or before the final visit were reported and up to 30 days after the end of the trial.
Adverse Events were obtained through spontaneous reports and subject interview.
|
|
General disorders
Back pain
|
6.3%
12/189 • All adverse events that occurred after administration of the first dose of study drug on or before the final visit were reported and up to 30 days after the end of the trial.
Adverse Events were obtained through spontaneous reports and subject interview.
|
|
General disorders
Asthenia
|
5.3%
10/189 • All adverse events that occurred after administration of the first dose of study drug on or before the final visit were reported and up to 30 days after the end of the trial.
Adverse Events were obtained through spontaneous reports and subject interview.
|
|
Gastrointestinal disorders
Constipation
|
6.9%
13/189 • All adverse events that occurred after administration of the first dose of study drug on or before the final visit were reported and up to 30 days after the end of the trial.
Adverse Events were obtained through spontaneous reports and subject interview.
|
|
Gastrointestinal disorders
Nausea
|
15.3%
29/189 • All adverse events that occurred after administration of the first dose of study drug on or before the final visit were reported and up to 30 days after the end of the trial.
Adverse Events were obtained through spontaneous reports and subject interview.
|
|
Gastrointestinal disorders
Vomiting
|
6.9%
13/189 • All adverse events that occurred after administration of the first dose of study drug on or before the final visit were reported and up to 30 days after the end of the trial.
Adverse Events were obtained through spontaneous reports and subject interview.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.3%
12/189 • All adverse events that occurred after administration of the first dose of study drug on or before the final visit were reported and up to 30 days after the end of the trial.
Adverse Events were obtained through spontaneous reports and subject interview.
|
|
Nervous system disorders
Dizziness
|
7.9%
15/189 • All adverse events that occurred after administration of the first dose of study drug on or before the final visit were reported and up to 30 days after the end of the trial.
Adverse Events were obtained through spontaneous reports and subject interview.
|
|
Nervous system disorders
Somnolence
|
9.0%
17/189 • All adverse events that occurred after administration of the first dose of study drug on or before the final visit were reported and up to 30 days after the end of the trial.
Adverse Events were obtained through spontaneous reports and subject interview.
|
|
Skin and subcutaneous tissue disorders
Erythema at site
|
32.3%
61/189 • All adverse events that occurred after administration of the first dose of study drug on or before the final visit were reported and up to 30 days after the end of the trial.
Adverse Events were obtained through spontaneous reports and subject interview.
|
|
Skin and subcutaneous tissue disorders
Pruritus at site
|
22.2%
42/189 • All adverse events that occurred after administration of the first dose of study drug on or before the final visit were reported and up to 30 days after the end of the trial.
Adverse Events were obtained through spontaneous reports and subject interview.
|
|
Skin and subcutaneous tissue disorders
Rash at site
|
17.5%
33/189 • All adverse events that occurred after administration of the first dose of study drug on or before the final visit were reported and up to 30 days after the end of the trial.
Adverse Events were obtained through spontaneous reports and subject interview.
|
|
Skin and subcutaneous tissue disorders
Other site reaction
|
9.0%
17/189 • All adverse events that occurred after administration of the first dose of study drug on or before the final visit were reported and up to 30 days after the end of the trial.
Adverse Events were obtained through spontaneous reports and subject interview.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.3%
10/189 • All adverse events that occurred after administration of the first dose of study drug on or before the final visit were reported and up to 30 days after the end of the trial.
Adverse Events were obtained through spontaneous reports and subject interview.
|
Additional Information
Clinical Leader, Executive Medical Director
Purdue Pharma L.P.
Phone: 800-733-1333 OR 800-745-7445
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60