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Buprenorphine Transdermal Patches (BTDS) in Subjects With Osteoarthritis Pain. Includes a 52-week Extension Phase.

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ClinicalTrials.gov Identifier: NCT00320801
Recruitment Status : Terminated (This study was terminated early due to administrative reasons.)
First Posted : May 3, 2006
Results First Posted : September 20, 2010
Last Update Posted : September 3, 2012
Sponsor:
Information provided by (Responsible Party):
Purdue Pharma LP

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Osteoarthritis
Intervention Drug: Buprenorphine transdermal patch
Enrollment 188
Recruitment Details 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).
Pre-assignment Details 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).
Arm/Group Title Run-in Period Double-blind BTDS 5 Double-blind BTDS 20 Extension Phase
Hide Arm/Group Description (≤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. Reference treatment: Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear Test treatment: buprenorphine transdermal patch 20 mcg/h applied for 7-day wear Subjects received open-label buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear for up to 52 weeks.
Period Title: Open-label Run-in Period
Started 188 0 0 0
Completed 96 0 0 0
Not Completed 92 0 0 0
Reason Not Completed
Withdrawal by Subject             2             0             0             0
Adverse Event             33             0             0             0
Administrative             10             0             0             0
Lack of Efficacy             44             0             0             0
Lost to Follow-up             2             0             0             0
Did not qualify             1             0             0             0
Period Title: Double-blind Phase
Started 0 47 49 0
Completed 0 36 35 0
Not Completed 0 11 14 0
Reason Not Completed
Withdrawal by Subject             0             0             1             0
Adverse Event             0             2             8             0
Administrative             0             0             4             0
Lack of Efficacy             0             9             1             0
Period Title: Extension Phase
Started 0 0 0 55
Completed 0 0 0 7
Not Completed 0 0 0 48
Reason Not Completed
Withdrawal by Subject             0             0             0             6
Adverse Event             0             0             0             8
Administrative             0             0             0             29
Lack of Efficacy             0             0             0             2
Lost to Follow-up             0             0             0             3
Arm/Group Title Double-blind BTDS 5 Double-blind BTDS 20 Total
Hide Arm/Group Description Reference treatment: Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear Test treatment: Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear Total of all reporting groups
Overall Number of Baseline Participants 47 49 96
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 47 participants 49 participants 96 participants
58.1  (11.65) 61.1  (11.72) 59.6  (11.72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 49 participants 96 participants
Female
34
  72.3%
28
  57.1%
62
  64.6%
Male
13
  27.7%
21
  42.9%
34
  35.4%
1.Primary Outcome
Title The Number of Participants With Adverse Events (AEs) as a Measure of Safety.
Hide Description Safety assessments included monitoring and recording of all adverse events and serious adverse events (SAEs).
Time Frame Throughout BTDS exposure (Includes run-in period, double-blind phase and extension phase)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Double-blind BTDS 5 Double-blind BTDS 20 Run-in Period Overall BTDS Exposure
Hide Arm/Group Description:
Reference treatment: Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
Test treatment: Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
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 core and extension phase combined (run-in period, double-blind phase, and extension phase)
Overall Number of Participants Analyzed 47 49 188 188
Measure Type: Number
Unit of Measure: Participants
Deaths 0 0 0 0
Serious adverse events 1 1 2 6
Other Adverse Events in ≥ 4.5% of subjects 17 22 52 101
Time Frame 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.
Adverse Event Reporting Description AEs were learned of by spontaneous reports, subject interview, and daily diary.
 
Arm/Group Title Double-blind BTDS 5 Double-blind BTDS 20 Open-label Run-in Period Overall BTDS Exposure
Hide Arm/Group Description Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear 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 core and extension phase combined (run-in period, double-blind phase, and extension phase)
All-Cause Mortality
Double-blind BTDS 5 Double-blind BTDS 20 Open-label Run-in Period Overall BTDS Exposure
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Double-blind BTDS 5 Double-blind BTDS 20 Open-label Run-in Period Overall BTDS Exposure
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/47 (2.13%)      1/49 (2.04%)      2/188 (1.06%)      6/188 (3.19%)    
Gastrointestinal disorders         
Nausea  1 [1]  0/47 (0.00%)  0 0/49 (0.00%)  0 2/188 (1.06%)  2 2/188 (1.06%)  2
General disorders         
Chest pain  1 [1]  0/47 (0.00%)  0 0/49 (0.00%)  0 1/188 (0.53%)  1 1/188 (0.53%)  1
Chest pressure  1 [1]  0/47 (0.00%)  0 0/49 (0.00%)  0 1/188 (0.53%)  1 1/188 (0.53%)  1
Hepatobiliary disorders         
Acute cholecystitis  1 [2]  0/47 (0.00%)  0 0/49 (0.00%)  0 0/188 (0.00%)  0 1/188 (0.53%)  1
Injury, poisoning and procedural complications         
Grade 2 splenic laceration  1 [1]  0/47 (0.00%)  0 0/49 (0.00%)  0 0/188 (0.00%)  0 1/188 (0.53%)  1
Right occipital condyle fracture  1 [1]  0/47 (0.00%)  0 0/49 (0.00%)  0 0/188 (0.00%)  0 1/188 (0.53%)  1
Comminuted pelvic fracture left  1 [1]  0/47 (0.00%)  0 0/49 (0.00%)  0 0/188 (0.00%)  0 1/188 (0.53%)  1
Right tibia-fibula fracture  1 [1]  0/47 (0.00%)  0 0/49 (0.00%)  0 0/188 (0.00%)  0 1/188 (0.53%)  1
Sphenoid fracture  1 [1]  0/47 (0.00%)  0 0/49 (0.00%)  0 0/188 (0.00%)  0 1/188 (0.53%)  1
Comminuted acetabulum left  1 [1]  0/47 (0.00%)  0 0/49 (0.00%)  0 0/188 (0.00%)  0 1/188 (0.53%)  1
Right lower lobe contusion on chest  1 [1]  0/47 (0.00%)  0 0/49 (0.00%)  0 0/188 (0.00%)  0 1/188 (0.53%)  1
Left post distal shaft fibular fracture  1 [1]  0/47 (0.00%)  0 0/49 (0.00%)  0 0/188 (0.00%)  0 1/188 (0.53%)  1
Left lower lobe contusion  1 [1]  0/47 (0.00%)  0 0/49 (0.00%)  0 0/188 (0.00%)  0 1/188 (0.53%)  1
Subarachnoid hemorrhage of fourth ventricle  1 [1]  0/47 (0.00%)  0 0/49 (0.00%)  0 0/188 (0.00%)  0 1/188 (0.53%)  1
Left hip fracture  1 [1]  0/47 (0.00%)  0 0/49 (0.00%)  0 0/188 (0.00%)  0 1/188 (0.53%)  1
Musculoskeletal and connective tissue disorders         
Neck pain  1 [1]  0/47 (0.00%)  0 0/49 (0.00%)  0 1/188 (0.53%)  1 1/188 (0.53%)  1
Nervous system disorders         
Dizziness  1 [1]  0/47 (0.00%)  0 0/49 (0.00%)  0 1/188 (0.53%)  1 1/188 (0.53%)  1
Headache  1 [1]  0/47 (0.00%)  0 0/49 (0.00%)  0 1/188 (0.53%)  1 1/188 (0.53%)  1
Somnolent  1 [1]  0/47 (0.00%)  0 0/49 (0.00%)  0 1/188 (0.53%)  1 1/188 (0.53%)  1
Worsening of reflex sympathetic dystrophy  1 [1]  1/47 (2.13%)  1 0/49 (0.00%)  0 0/188 (0.00%)  0 1/188 (0.53%)  1
Renal and urinary disorders         
Kidney stone  1 [1]  0/47 (0.00%)  0 1/49 (2.04%)  1 0/188 (0.00%)  0 1/188 (0.53%)  1
Respiratory, thoracic and mediastinal disorders         
Shortness of breath  1 [1]  0/47 (0.00%)  0 0/49 (0.00%)  0 1/188 (0.53%)  1 1/188 (0.53%)  1
Skin and subcutaneous tissue disorders         
Diaphoresis  1 [1]  0/47 (0.00%)  0 0/49 (0.00%)  0 1/188 (0.53%)  1 1/188 (0.53%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
[1]
Systematic and nonsystematic assessments.
[2]
Systematic and nonsystematic assessments
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4.50%
Double-blind BTDS 5 Double-blind BTDS 20 Open-label Run-in Period Overall BTDS Exposure
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   17/47 (36.17%)      22/49 (44.90%)      52/188 (27.66%)      101/188 (53.72%)    
Gastrointestinal disorders         
Nausea  1 [1]  4/47 (8.51%)  3/49 (6.12%)  30/188 (15.96%)  38/188 (20.21%) 
Vomiting NOS  1 [1]  1/47 (2.13%)  2/49 (4.08%)  16/188 (8.51%)  21/188 (11.17%) 
Constipation  1 [1]  1/47 (2.13%)  5/49 (10.20%)  4/188 (2.13%)  9/188 (4.79%) 
General disorders         
Edema peripheral  1 [1]  4/47 (8.51%)  4/49 (8.16%)  5/188 (2.66%)  18/188 (9.57%) 
Application site pruritus  1 [1]  3/47 (6.38%)  5/49 (10.20%)  9/188 (4.79%)  17/188 (9.04%) 
Application site erythema  1 [1]  3/47 (6.38%)  5/49 (10.20%)  4/188 (2.13%)  14/188 (7.45%) 
Application site rash  1 [1]  2/47 (4.26%)  1/49 (2.04%)  7/188 (3.72%)  15/188 (7.98%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1 [1]  1/47 (2.13%)  6/49 (12.24%)  3/188 (1.60%)  16/188 (8.51%) 
Myalgia  1 [1]  3/47 (6.38%)  0/49 (0.00%)  0/188 (0.00%)  4/188 (2.13%) 
Pain in limb  1 [1]  1/47 (2.13%)  2/49 (4.08%)  4/188 (2.13%)  11/188 (5.85%) 
Nervous system disorders         
Headache  1 [1]  4/47 (8.51%)  2/49 (4.08%)  16/188 (8.51%)  24/188 (12.77%) 
Dizziness  1 [1]  2/47 (4.26%)  1/49 (2.04%)  15/188 (7.98%)  20/188 (10.64%) 
Somnolence  1 [1]  2/47 (4.26%)  2/49 (4.08%)  6/188 (3.19%)  10/188 (5.32%) 
Psychiatric disorders         
Anxiety  1 [1]  3/47 (6.38%)  0/49 (0.00%)  1/188 (0.53%)  5/188 (2.66%) 
Skin and subcutaneous tissue disorders         
Pruritus  1 [1]  0/47 (0.00%)  1/49 (2.04%)  8/188 (4.26%)  9/188 (4.79%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
[1]
Systematic and nonsystematic assessments.
Study terminated due to administrative reasons. The primary objective was changed to a safety study prior to unblinding.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Clinical Leader, Executive Medical Director
Organization: Purdue Pharma L.P.
Phone: 800-733-1333
Responsible Party: Purdue Pharma LP
ClinicalTrials.gov Identifier: NCT00320801     History of Changes
Obsolete Identifiers: NCT01137422
Other Study ID Numbers: BUP3014 and BUP3014S
First Submitted: April 28, 2006
First Posted: May 3, 2006
Results First Submitted: July 28, 2010
Results First Posted: September 20, 2010
Last Update Posted: September 3, 2012