drugset
drugset / Trial / NCT00403234

Safety of Buprenorphine Transdermal System (BTDS) in Subjects With Acute Postoperative Pain After Total Knee Replacement

NCT00403234 ↗

Phase 2 Terminated 10 enrolled Purdue Pharma LP
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2006-11
Primary completion
2007-04
Completion
2007-08

Outcome

Outcome not reported

Stopped: “due to administrative reasons not related to efficacy or safety.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Buprenorphine Other / unclassified 10 unknown Other
Subject Buprenorphine Other / unclassified 20 unknown Other
Subject Buprenorphine Other / unclassified 30 unknown Other

Indications

No indication recorded.