drugset / Trial / NCT00315445
The Safety and Efficacy of the Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Back Pain.
RandomizedParallel-groupDouble-blindTreatment
Summary
The objective of this study is to assess the safety of the buprenorphine transdermal system (5, 10, and 20) in comparison to placebo transdermal system and immediate release oxycodone/ acetaminophen in subjects with chronic back pain. The double-blind treatment intervention duration is 84 days during which time supplemental analgesic medication (non-steroidal anti-inflammatory drugs) will be allowed for all subjects in addition to study drug.
Timeline
- Start
- 1997-12
- Primary completion
- 1998-05
- Completion
- 1998-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Acetaminophen | Small molecule | 325 mg | Oral |
| Subject | Buprenorphine | Other / unclassified | 5 ug | Other |
| Subject | Buprenorphine | Other / unclassified | 10 ug | Other |
| Subject | Buprenorphine | Other / unclassified | 20 ug | Other |
| Comparator | Oxycodone | Other / unclassified | 5 mg | Oral |
Indications
No indication recorded.