Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Osteoarthritis Pain.

Completed · Phase 3

Conditions studied: Osteoarthritis

In brief

The objective of this study is to assess the safety and efficacy of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system in subjects with osteoarthritis pain. The double-blind treatment intervention duration is 28 days.

Key facts

Study ID

NCT00314652

Run by

Purdue Pharma LP

People needed

260

Starts

1999-06-01

Expected to finish

1999-10-01

Last updated by the study team

2006-05-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• documented history and/or radiologic evidence of chronic osteoarthritis of the hip or knee.
• receiving opioid therapy for osteoarthritis-related pain within the past year or have experienced pain that was inadequately controlled with a full standard dose of NSAIDs.

You may not qualify if…

• receiving opioids at an average daily dose of greater than 90 mg of oral morphine equivalents or patients receiving more than 12 tablets or capsules per day of short-acting opioid-containing products
• scheduled to have surgery (including dental) during the study period that involved the use of pre- and/or postoperative analgesics or anesthetics.
• Other protocol-specific exclusion/inclusion criteria may apply.

Where it is running

• Hawthorne & York, International, Ltd. — Phoenix, Arizona, United States
• Arizona Research Center, LLC — Phoenix, Arizona, United States
• ACRC/Arizona Clinical Research — Tucson, Arizona, United States
• Advanced Clinical Therapeutics — Tucson, Arizona, United States
• San Diego Arthritis and Osteoporosis Research — San Diego, California, United States
• Scripps Clinic Rancho Bernardo — San Diego, California, United States
• Clinical Research Consultants, Inc. — Trumbull, Connecticut, United States
• Tampa Bay Medical Research, Inc. — Clearwater, Florida, United States
• University Clinical Research — DeLand, Florida, United States
• Gainesville Clinical Research Center — Gainesville, Florida, United States
• Physicians Research Associates Jacksonville — Jacksonville, Florida, United States
• University Clinical Research, Inc. — Pembroke Pines, Florida, United States
• Gold Coast Research, Inc. — Weston, Florida, United States
• MediSphere Medical Research Center, LLC — Evansville, Indiana, United States
• Westside Family Medical Center — Kalamazoo, Michigan, United States
• Center for Pharmaceutical Research — Kansas City, Missouri, United States
• NJP Clinical Research — Passaic, New Jersey, United States
• PW Clinical Research, LLC — Winston-Salem, North Carolina, United States
• New Century Research Center, Ltd. — Beaverbrook, Ohio, United States
• Altoona Center for Clinical Research — Duncansville, Pennsylvania, United States
• Mid-South Clinical Research Institute — Memphis, Tennessee, United States
• Advanced Clinical Research — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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