Safety and Efficacy of Buprenorphine Transdermal System in Subjects With Moderate to Severe Osteoarthritis of Hip or Knee

Completed · Phase 3 · Has a placebo group

Conditions studied: Osteoarthritis

In brief

The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) (5, 10 and 20) in comparison to placebo transdermal system in subjects with moderate to severe osteoarthritis pain of the hip and knee currently treated with oral opioids. The double-blind treatment intervention duration is 4 weeks during which time supplemental analgesic medication (acetaminophen) will be provided to all subjects in addition to study drug.

Key facts

Study ID

NCT00313846

Run by

Purdue Pharma LP

People needed

529

Starts

2003-04-01

Expected to finish

2004-06-01

Last updated by the study team

2012-09-03

Who can join

Age: 40 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• clinical diagnosis of chronic osteoarthritis of the hip or knee for 1 year or longer.
• an average pain due to osteoarthritis of moderate, moderately-severe, or severe for the 14 days prior to enrollment.

You may not qualify if…

• ingest opioid analgesics on a daily basis.
• ingest >2500 milligrams (mg) acetaminophen on a daily basis.
• require <20 mg or >80 mg of morphine (or opioid equivalents) per day for control of their osteoarthritis pain.
• Other protocol-specific exclusion/inclusion criteria may apply.

Where it is running

• Vista Medical Research — Mesa, Arizona, United States
• Arizona Research Center — Phoenix, Arizona, United States
• Radiant Research — Phoenix, Arizona, United States
• Arizona Research Center — Phoenix, Arizona, United States
• ACRC/Arizona Clinical Research — Tucson, Arizona, United States
• Advance Pain Medicine — Bakersfield, California, United States
• Eastgate Medical Center — Cypress, California, United States
• University Osteoporosis Ctr — Loma Linda, California, United States
• San Diego Arthritis & Osteoporosis Medical Clinic — San Diego, California, United States
• Scripps Clinic Rancho Bernard — San Diego, California, United States
• CNS Clinical Trials, Inc — San Francisco, California, United States
• Mountain View Clinical Research — Denver, Colorado, United States
• Integrative Treatment Centers/Rocky Mtn Clin Res — Westminster, Colorado, United States
• Rocky Mountain Center for Clinical Research — Wheat Ridge, Colorado, United States
• Stamford Therapeutic Consortium — Bridgeport, Connecticut, United States
• Medical Specialists of the Palm Beaches — Atlantis, Florida, United States
• University Clinical Research Deland — DeLand, Florida, United States
• Drug Study Institute — Jupiter, Florida, United States
• Coastal Medical Research — Orange City, Florida, United States
• Coastal Medical Research — Port Orange, Florida, United States
• Palm Beach Research Center — West Palm Beach, Florida, United States
• Gold Coast Research — Weston, Florida, United States
• Non-Surgical Orthopedic & Spine Center — Marietta, Georgia, United States
• Columbus Internal Medical Associates — Columbus, Indiana, United States
• MediSphere Medical Research Ctr. — Evansville, Indiana, United States

Full record on ClinicalTrials.gov

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