Safety of Buprenorphine Transdermal System (BTDS) in Subjects With Acute Postoperative Pain After Total Knee Replacement
Status:
Terminated
Trial end date:
2007-08-01
Target enrollment:
Participant gender:
Summary
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.