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NCT00315458 Clinical Trial

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

Osteoarthritis Clinical Trial

Official title:
Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study to Determine Efficacy and Safety of Buprenorphine Transdermal System in Subjects With Moderate To Severe Osteoarthritis Pain Requiring Daily Treatment With Opioids

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00315458
Other study ID # BUP3011 and BUP3011S
Secondary ID
Status Terminated
Phase Phase 3
First received April 17, 2006
Last updated August 27, 2012
Start date December 2003
Est. completion date March 2005

Study information
Verified date August 2012
Source Purdue Pharma LP
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.

Description:

Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain.

Other known NCT identifiers
  • NCT01137279

Recruitment information / eligibility
Status Terminated
Enrollment 107
Est. completion date March 2005
Est. primary completion date March 2005
Accepts healthy volunteers No
Gender Both
Age group 40 Years and older
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Buprenorphine transdermal patch
Buprenorphine transdermal patch applied for 7-day wear.
• Placebo transdermal patch
Placebo to match buprenorphine transdermal patch 10 or 20.

Locations
Country Name City State
United States Keystone Clinical Solutions Altoona Pennsylvania
United States Bay Area Health Clinic Bay City Michigan
United States Clinical Research Consultants Birmingham Alabama
United States Parkway Medical Center Birmingham Alabama
United States Comprehensive Neuroscience Inc Boynton Beach Florida
United States Holston Medical Group Bristol Tennessee
United States Southbay Pharma Research Buena Park California
United States Low Country Rheumatology Charleston South Carolina
United States Chiefland Medical Center Chiefland Florida
United States University Clinical Research Deland Deland Florida
United States Altoona Center for Clinical Research Duncansville Pennsylvania
United States MediSphere Medical Research Center Evansville Indiana
United States Florida Medical Research Institute Gainesville Florida
United States Internal Medicine Northwest Gurnee Illinois
United States Winston Physician Services, Inc Haleyville Alabama
United States Team Research of Central Texas Harker Heights Texas
United States Drug Study Institute Jupiter Florida
United States University of Arkansas for Medical Sciences Little Rock Arkansas
United States University of Louisville Medical/Rheumatology Louisville Kentucky
United States Georgia Medical Research Institute Marietta Georgia
United States CSS Research Memphis Tennessee
United States Clinical Trials Management, LLC Metairie Louisiana
United States Private Practice Muscle Shoals Alabama
United States Beth Israel Medical Center New York New York
United States Health Research Institute Oklahoma City Oklahoma
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 Arizona Research Center Phoenix Arizona
United States Radiant Research Phoenix Arizona
United States Coastal Medical Research Port Orange Florida
United States Quality Research San Antonio Texas
United States Prime Care Medical Center Selmer Tennessee
United States BioMedical Research Associates Shippensburg Pennsylvania
United States Physicians Clinic of Spokane Spokane Washington
United States Future Care Studies Springfield Massachusetts
United States Medex Healthcare Research Inc St Louis Missouri
United States University Orthopedics Center State College Pennsylvania
United States Torrence Clinical Research Torrance California
United States Clinic for Rheumatic Diseases Tuscaloosa Alabama
United States ACRC/Arizona Clinical Research Tuscon Arizona
United States Advanced Pain Management and Rehab Hilltop Med Center Virginia Beach Virginia
United States Sentara Medical Group Virginia Beach Virginia
United States Omega Medical Research Warwick Rhode Island
United States Brown Clinic Watertown South Dakota
United States Palm Beach Research Center West Palm Beach Florida
United States Gold Coast Research LLC Weston Florida

Sponsors (1)
Lead Sponsor Collaborator
Purdue Pharma LP

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants With Adverse Events (AEs) as a Measure of Safety For the Run-in and double-blind phases of the study, the focus of this study was changed before unblinding to a safety study due to early termination and having enrolled only 35% of the planned sample size. Therefore, the safety data is presented for the run-in and double-blind and overall exposure to BTDS, which includes the extension phase. 483 days Yes
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