Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Osteoarthritis Pain

Stopped early · Phase 3

Conditions studied: Osteoarthritis

In brief

The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (20 mg) in comparison to the buprenorphine transdermal system (5 mg) and oxycodone immediate release in subjects with moderate to severe osteoarthritis pain currently treated with oral opioids. The double-blind treatment intervention duration is 12 weeks during which time supplemental analgesic medication (acetaminophen, ibuprofen, immediate release oxycodone) will be provided to all subjects in addition to study drug.

Key facts

Study ID

NCT00312221

Run by

Purdue Pharma LP

People needed

418

Starts

2004-04-01

Expected to finish

2005-08-01

Last updated by the study team

2012-09-10

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Osteoarthritis of the hip, knee, or spine for 1 year or longer, confirmed by radiographic evidence within the last 2 years.
• Good pain control while on a stable dose of an opioid analgesic for osteoarthritis.

You may not qualify if…

• Not currently taking and tolerating opioids.
• Taking more than 80 mg per day of oral morphine sulfate or equivalent within 30 days of enrollment.
• Requiring frequent analgesic therapy for chronic condition(s), in addition to osteoarthritis.
• Other protocol-specific exclusion/inclusion criteria may apply.

Where it is running

• Parkway Medical Center — Birmingham, Alabama, United States
• International Clinical Research Network — Chula Vista, California, United States
• Clinical Trials Research — Roseville, California, United States
• Accelovance — San Diego, California, United States
• Torrance Clinical Research — Torrance, California, United States
• Southern Colorado Clinic — Pueblo, Colorado, United States
• Drug Study Institute — Jupiter, Florida, United States
• Innovative Research of West Florida, Inc. — Largo, Florida, United States
• International Medical Research — Ormond Beach, Florida, United States
• Peninsula Research, Inc. — Ormond Beach, Florida, United States
• Palm Beach Research Center — West Palm Beach, Florida, United States
• Georgia Medical Research Institute — Marietta, Georgia, United States
• Non- Surgical Orthopedic & Spine Center, P.C. — Marietta, Georgia, United States
• The Arthritis Center — Springfield, Illinois, United States
• Commonwealth Biomedical Research, LLC — Madisonville, Kentucky, United States
• Miray Medical Center — Brockton, Massachusetts, United States
• Professional Clinical Research Crystal Lake Health Center — Benzonia, Michigan, United States
• Rheumatology PC — Kalamazoo, Michigan, United States
• Pharm Quest — Greensboro, North Carolina, United States
• The Clinical Trial Center, LLC — Jenkintown, Pennsylvania, United States
• Amarillo Center for Clinical Research — Amarillo, Texas, United States
• Med Search Professional Group/Pharmaceutical C-Trials Inc. — Hurst, Texas, United States
• Texas Medical Research Associates — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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