Safety and Efficacy of Dose Conversion From Vicodin® to Buprenorphine Transdermal System (Butrans™) in Subjects With OA Pain

Completed · Phase 3

Conditions studied: Osteoarthritis

In brief

The objective of this study is to evaluate the safety and efficacy of dose conversion from hydrocodone/ acetaminophen (Vicodin®) to the buprenorphine transdermal system (Butrans™) in subjects with osteoarthritis pain of the hip or knee. The double-blind treatment intervention duration is 2 weeks during which time supplemental analgesic medication will be allowed.

Key facts

Study ID

NCT00312572

Run by

Purdue Pharma LP

People needed

204

Starts

2003-06-01

Expected to finish

2004-07-01

Last updated by the study team

2012-09-03

Who can join

Age: 40 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• osteoarthritis of the hip or knee taking a regularly scheduled regimen of hydrocodone/ acetaminophen for their osteoarthritis OA pain.

You may not qualify if…

• currently have condition requiring a stable regimen of acetaminophen (APAP).
• a history of chronic conditions, other than OA of the hip or knee joints, requiring frequent, intermittent analgesic therapy.
• Other protocol-specific exclusion/inclusion criteria may apply.

Where it is running

• Southern Drug Research — Birmingham, Alabama, United States
• Redpoint Research — Phoenix, Arizona, United States
• Advanced Clinical Therapeutics — Tucson, Arizona, United States
• Tucson Orthopedic Institute — Tucson, Arizona, United States
• Hot Springs Mercy Pain Clinic — Hot Springs, Arkansas, United States
• Private Practice — Pine Bluff, Arkansas, United States
• Advanced Clinical Research Institute — Anaheim, California, United States
• Lovelace Scientific Resources — Beverly Hills, California, United States
• Southbay Pharma Research — Buena Park, California, United States
• Community Medical Providers — Clovis, California, United States
• Kaiser Permanente — Escondido, California, United States
• Univ. of Southern California — Santa Monica, California, United States
• Arthritis Center of CT — Waterbury, Connecticut, United States
• Lifespan Research Foundation, Inc. — Miami, Florida, United States
• Miami Beach Anesthesiology Associates — Miami Beach, Florida, United States
• Neuro Science and Spine Assoc. — Naples, Florida, United States
• West Broward Rheumatology Association, Inc. — Tamarac, Florida, United States
• Intermountain Orthopaedics — Boise, Idaho, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Bluegrass Orthopaedics — Lexington, Kentucky, United States
• Commonwealth Biomedical Research, LLC — Madisonville, Kentucky, United States
• Dolby Providers, Inc. — New Orleans, Louisiana, United States
• Clinical Pharmacology Study Group — Worcester, Massachusetts, United States
• Westside Family Medical Center — Kalamazoo, Michigan, United States
• PCM Medical Services — Lansing, Michigan, United States

Full record on ClinicalTrials.gov

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