Buprenorphine Transdermal Patch in Subjects With Osteoarthritis Pain Requiring Opioids. Includes a 52-Week Safety Extension.

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Osteoarthritis

In brief

The original objective of this study was to assess the safety and efficacy of the buprenorphine transdermal system (BTDS) (5, 10, and 20) in comparison to placebo transdermal system in subjects with moderate to severe osteoarthritis pain. However, this study was terminated early with only 35% of the planned sample size, therefore the primary objective is changed to focus on the safety evaluations.

Key facts

Study ID

NCT00315458

Run by

Purdue Pharma LP

People needed

107

Starts

2003-12-01

Expected to finish

2005-03-01

Last updated by the study team

2012-09-03

Who can join

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

You may qualify if…

• clinical evidence of osteoarthritis of the hip, knee, or spine joint for ≥ 1 year currently adequately treated with short acting opioids.
• taking ≥ 30 and ≤ 80 mg oral morphine or morphine equivalents per day for ≥ 2 weeks for control of their osteoarthritis pain.

You may not qualify if…

• requiring frequent analgesic therapy for chronic condition(s), other than osteoarthritis of the hip, knee, or spine.
• scheduled for surgery of the disease site (e.g., major joint replacement surgery), or any other major surgery that would fall within the study period.
• Other protocol-specific exclusion/inclusion criteria may apply.

Where it is running

• Parkway Medical Center — Birmingham, Alabama, United States
• Clinical Research Consultants — Birmingham, Alabama, United States
• Winston Physician Services, Inc — Haleyville, Alabama, United States
• Private Practice — Muscle Shoals, Alabama, United States
• Clinic for Rheumatic Diseases — Tuscaloosa, Alabama, United States
• Radiant Research — Phoenix, Arizona, United States
• Arizona Research Center — Phoenix, Arizona, United States
• ACRC/Arizona Clinical Research — Tuscon, Arizona, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Southbay Pharma Research — Buena Park, California, United States
• Torrence Clinical Research — Torrance, California, United States
• Comprehensive Neuroscience Inc — Boynton Beach, Florida, United States
• Chiefland Medical Center — Chiefland, Florida, United States
• University Clinical Research Deland — DeLand, Florida, United States
• Florida Medical Research Institute — Gainesville, Florida, United States
• Drug Study Institute — Jupiter, Florida, United States
• Coastal Medical Research — Orange City, Florida, United States
• Ormond Medical Arts Pharmaceutical Res Ctr — Ormond Beach, Florida, United States
• The Arthritis Center — Palm Harbor, Florida, United States
• Avancia Research — Pembroke Pines, Florida, United States
• Coastal Medical Research — Port Orange, Florida, United States
• Palm Beach Research Center — West Palm Beach, Florida, United States
• Gold Coast Research LLC — Weston, Florida, United States
• Georgia Medical Research Institute — Marietta, Georgia, United States
• Internal Medicine Northwest — Gurnee, Illinois, United States

Full record on ClinicalTrials.gov

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