Postoperative Pain Clinical Trial
Official title:
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Pilot Study to Evaluate the Analgesic Efficacy of BTDS on Postoperative Pain During Rehabilitation Following Total Knee Arthroplasty
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.
Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain. ;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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