Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Osteoarthritis Pain
Summary
The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (20 mg) in comparison to the buprenorphine transdermal system (5 mg) and oxycodone immediate release in subjects with moderate to severe osteoarthritis pain currently treated with oral opioids. The double-blind treatment intervention duration is 12 weeks during which time supplemental analgesic medication (acetaminophen, ibuprofen, immediate release oxycodone) will be provided to all subjects in addition to study drug.
Timeline
- Start
- 2004-04
- Primary completion
- 2005-07
- Completion
- 2005-08
Outcome
Missed primary endpoint
Stopped: “terminated early for administrative reasons unrelated to safety or efficacy”
registry analysis (superiority or other test); Double-blind BTDS 5 vs Double-blind BTDS 20; p = 0.126; Mean Difference (Final Values) -0.38 (95% CI -0.8562 to 0.1054); Mixed Models Analysis NCT00312221 ↗
registry analysis (superiority or other test); Double-blind BTDS 5 vs Double-blind Oxycodone Immediate-Release; p = 0.140; Mean Difference (Final Values) -0.36 (95% CI -0.8455 to 0.1189); Mixed Models Analysis NCT00312221 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Buprenorphine | Other / unclassified | 5 ug | Other |
| Subject | Buprenorphine | Other / unclassified | 20 ug | Other |
| Subject | oxycodone immediate-release | Unknown | 40 mg | Oral |