Safety and Efficacy of Dose Conversion From Vicodin® to Buprenorphine Transdermal System (Butrans™) in Subjects With OA Pain
Completed
Purdue Pharma LP
Phase 3
2003-06-01
The objective of this study is to evaluate the safety and efficacy of dose conversion from
hydrocodone/ acetaminophen (Vicodin®) to the buprenorphine transdermal system (Butrans™) in
subjects with osteoarthritis pain of the hip or knee. The double-blind treatment intervention
duration is 2 weeks during which time supplemental analgesic medication will be allowed.
Safety of Buprenorphine Transdermal System (BTDS) in Subjects With Acute Postoperative Pain After Total Knee Replacement
Terminated
Purdue Pharma LP
Phase 2
2006-11-01
The objectives in this study are to evaluate: (1) efficacy of buprenorphine transdermal
system (BTDS, Butrans™) on postoperative pain following total knee replacement surgery; (2)
the impact of BTDS on functional rehabilitative measures after total knee replacement
surgery; and 3) the safety of BTDS after total knee replacement surgery. The double-blind
treatment period is for 28 days during which time supplemental analgesic medication will be
provided to all subjects in addition to study drug.
Purdue Pharma L.P. terminated the trial early due to administrative reasons not related to
efficacy or safety. The focus of this study became safety evaluations.
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