Buprenorphine Transdermal Patch in Subjects With Osteoarthritis Pain Requiring Opioids. Includes a 52-Week Safety Extension.
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|ClinicalTrials.gov Identifier: NCT00315458|
Recruitment Status : Terminated (Administrative reasons.)
First Posted : April 18, 2006
Results First Posted : September 23, 2010
Last Update Posted : September 3, 2012
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis||Drug: Buprenorphine transdermal patch Drug: Placebo transdermal patch||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||107 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study to Determine Efficacy and Safety of Buprenorphine Transdermal System in Subjects With Moderate To Severe Osteoarthritis Pain Requiring Daily Treatment With Opioids|
|Study Start Date :||December 2003|
|Actual Primary Completion Date :||March 2005|
|Actual Study Completion Date :||March 2005|
Buprenorphine transdermal patches 10 or 20 mcg/h
Drug: Buprenorphine transdermal patch
Buprenorphine transdermal patch applied for 7-day wear.
Other Name: Butrans™
Placebo Comparator: Placebo
Placebo to match buprenorphine transdermal patch 10 or 20
Drug: Placebo transdermal patch
Placebo to match buprenorphine transdermal patch 10 or 20.
- Number of Participants With Adverse Events (AEs) as a Measure of Safety [ Time Frame: 483 days ]For the Run-in and double-blind phases of the study, the focus of this study was changed before unblinding to a safety study due to early termination and having enrolled only 35% of the planned sample size. Therefore, the safety data is presented for the run-in and double-blind and overall exposure to BTDS, which includes the extension phase.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00315458