drugset / Trial / NCT00403234
Safety of Buprenorphine Transdermal System (BTDS) in Subjects With Acute Postoperative Pain After Total Knee Replacement
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
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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.