The Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Osteoarthritis Pain.

Completed · Phase 3

Conditions studied: Osteoarthritis

In brief

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.

Key facts

Study ID

NCT00315848

Run by

Purdue Pharma LP

People needed

225

Starts

1996-11-01

Expected to finish

1999-12-01

Last updated by the study team

2006-05-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• unacceptable pain control despite currently taking a nonsteroidal anti-inflammatory drug considered at a therapeutic and/or tolerated dose or currently taking </=2 short-acting opioid doses per day.
• taking >/=3 opioid doses per day with or without acceptable pain control.

You may not qualify if…

• 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.

Where it is running

• Rheumatology Associates of North Alabama — Huntsville, Alabama, United States
• Arizona Research and Education — Phoenix, Arizona, United States
• Phoenix Center for Clinical Research — Phoenix, Arizona, United States
• Western Integrated Pain Treatment Centers — Westminster, Colorado, United States
• Gainesville Clinical Research Center — Gainesville, Florida, United States
• Park Place Therapeutic Center — Plantation, Florida, United States
• MediSphere Medical Research Center, L.L.C. — Evansville, Indiana, United States
• Stratton VA Medical Center — Albany, New York, United States
• Metroplex Clinical Research Center — Dallas, Texas, United States
• Arthritis Diagnostic and Treatment Center — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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