Buprenorphine Transdermal Patches (BTDS) in Subjects With Osteoarthritis Pain. Includes a 52-week Extension Phase.

Stopped early · Phase 3

Conditions studied: Osteoarthritis

In brief

The original objective of this study was to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) 20 micrograms (mcg)/hour (h) in comparison to the buprenorphine transdermal system 5 mcg/h 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 or ibuprofen) will be provided to all subjects in addition to study drug. This study was terminated early due to administrative reasons with only 20% of the planned sample size; therefore, the primary objective was changed to focus on the safety evaluation.

Key facts

Study ID

NCT00320801

Run by

Purdue Pharma LP

People needed

188

Starts

2004-01-01

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…

• osteoarthritis of the hip, knee, or spine for 1 year or longer.
• taking between 30-80 milligrams (mg) of oral morphine sulfate or equivalent/day, at least 4 days a week.

You may not qualify if…

• taking more than 80 mg per day of oral morphine sulfate or equivalent within 30 days of enrollment.
• requiring frequent analgesic therapy for chronic conditions in addition to osteoarthritis.
• Other protocol-specific exclusion/inclusion criteria may apply.

Where it is running

• Edwards Lake Medical Center — Birmingham, Alabama, United States
• Rheumatogogy Associates of N. Alabama, — Huntsville, Alabama, United States
• Drug Research and Analysis Corp. — Montgomery, Alabama, United States
• Meadowbrook Research — Scottsdale, Arizona, United States
• Research Solutions, LLC — Searcy, Arizona, United States
• Central Arkansas Research — Hot Springs, Arkansas, United States
• Crest Clinical Research, Inc — Anaheim, California, United States
• NuLife Clinical Research, Inc. — Anaheim, California, United States
• Orange County Clinical Research — Cypress, California, United States
• Private Practice — Laguna Hills, California, United States
• Andwell Research — Laguna Niguel, California, United States
• Valerius Medical Group & Research Center Inc. — Long Beach, California, United States
• Anesthesiology and Pain Management — Los Gatos, California, United States
• Scripps Clinic Ranchro Bernardo — San Diego, California, United States
• Orrin M. Troum & Medical Associates — Santa Monica, California, United States
• Diablo Clinical Research — Walnut Creek, California, United States
• Private Practice — Arvada, Colorado, United States
• Mountainview Clinical Research — Denver, Colorado, United States
• Private Practice — Aventura, Florida, United States
• Medical Research Associates — Clearwater, Florida, United States
• LifeSpan Clinical Research — Miami, Florida, United States
• Ocala Rheumatology Research Center — Ocala, Florida, United States
• Family Practice of St. Cloud PA Wilker/Powers Center for Clinical Studies — Saint Cloud, Florida, United States
• Wilker/Powers Center for Clinical Studies — Saint Cloud, Florida, United States
• Parkway Medical Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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