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Safety and Efficacy of Buprenorphine TDS (Transdermal Delivery System) 5, 10 and 20 Applied Every 7 Days for Sixty Days vs. 5 mg Oxycodone/325 mg Acetaminophen Tablets q6h Prn vs. Placebo in Patients With Chronic Low Back Pain
The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system and immediate release oxycodone/acetaminophen in subjects with chronic low back pain inadequately treated with non-opioid analgesics. The double-blind treatment intervention duration is 60 days.
Details
| Lead sponsor | Purdue Pharma LP |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 225 |
| Start date | 1997-04 |
| Completion | 1998-01 |
Conditions
- Back Pain
Interventions
- Buprenorphine transdermal delivery system
Primary outcomes
- Pain on average and pain right now scores at days 0, 9, 15, 30, 45, 60, or if applicable, at early termination.
Countries
United States