A Multi-Center, Randomized, Double-Blind, Parallel Group Study of the Safety and Efficacy of Buprenorphine Transdermal Delivery System Vs. Oxycodone/Acetaminophen Tablets Vs. Placebo in Patients With Chronic Pain Due to Osteoarthritis
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Purdue Pharma LP
- Enrollment
- 225
- Locations
- 10
- Primary Endpoint
- Pain on average and pain right now scores at days 0, 9, 15, 30, 45, 60, or at early termination.
Study Overview
Brief Summary
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 osteoarthritis pain inadequately treated with non-opioid analgesics. The double-blind treatment intervention duration is 60 days.
Detailed Description
Buprenorphine is a synthetic opioid analgesic with over twenty-five years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain. Transdermal systems may offer advantages over currently indicated oral products including ease and convenience of use, improved compliance, possible reduction in patient care, and prolonged and consistent delivery of drug.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •* unacceptable pain control despite currently taking a nonsteroidal anti-inflammatory drug considered at a therapeutic and/or tolerated dose or currently taking \/=3 opioid doses per day with or without acceptable pain control.
Exclusion Criteria
- •receiving opioids at an average daily dose of greater than 60 mg of oral morphine equivalents or subjects receiving more than 6 tablets per day of a short-acting opioid.
- •scheduled to have surgery (including dental) involving the use of post- or preoperative analgesics or anesthetics during the study period.
- •Other protocol-specific exclusion/inclusion criteria may apply.
Outcomes
Primary Outcomes
Pain on average and pain right now scores at days 0, 9, 15, 30, 45, 60, or at early termination.
Secondary Outcomes
- Brief Pain Inventory
- dropouts due to lack of efficacy
- MOS health survey
- VAS pain intensity
- therapeutic response
- patient preference
- daily patient diary
- and number of oxycodone/acetaminophen or placebo tablets taken