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

NCT ID: NCT00315458

Last Updated: 2012-09-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 107 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-12-31
• Study Completion Date: 2005-03-31

Brief 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.

Detailed 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.

Conditions

Osteoarthritis

Keywords

osteoarthritis; opioid; transdermal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BTDS

Buprenorphine transdermal patches 10 or 20 mcg/h

Group Type: EXPERIMENTAL

Buprenorphine transdermal patch

Intervention Type: DRUG

Buprenorphine transdermal patch applied for 7-day wear.

Placebo

Placebo to match buprenorphine transdermal patch 10 or 20

Group Type: PLACEBO_COMPARATOR

Placebo transdermal patch

Intervention Type: DRUG

Placebo to match buprenorphine transdermal patch 10 or 20.

Interventions

Buprenorphine transdermal patch

Buprenorphine transdermal patch applied for 7-day wear.

Intervention Type: DRUG

Placebo transdermal patch

Placebo to match buprenorphine transdermal patch 10 or 20.

Intervention Type: DRUG

Other Intervention Names

Butrans™

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Purdue Pharma LP

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

MediSphere Medical Research Center

Evansville, Indiana, United States

University of Louisville Medical/Rheumatology

Louisville, Kentucky, United States

Clinical Trials Management, LLC

Metairie, Louisiana, United States

Future Care Studies

Springfield, Massachusetts, United States

Bay Area Health Clinic

Bay City, Michigan, United States

Medex Healthcare Research Inc

St Louis, Missouri, United States

Beth Israel Medical Center

New York, New York, United States

Health Research Institute

Oklahoma City, Oklahoma, United States

Keystone Clinical Solutions

Altoona, Pennsylvania, United States

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States

BioMedical Research Associates

Shippensburg, Pennsylvania, United States

University Orthopedics Center

State College, Pennsylvania, United States

Omega Medical Research

Warwick, Rhode Island, United States

Low Country Rheumatology

Charleston, South Carolina, United States

Brown Clinic

Watertown, South Dakota, United States

Holston Medical Group

Bristol, Tennessee, United States

CSS Research

Memphis, Tennessee, United States

Prime Care Medical Center

Selmer, Tennessee, United States

Team Research of Central Texas

Harker Heights, Texas, United States

Quality Research

San Antonio, Texas, United States

Advanced Pain Management and Rehab Hilltop Med Center

Virginia Beach, Virginia, United States

Sentara Medical Group

Virginia Beach, Virginia, United States

Physicians Clinic of Spokane

Spokane, Washington, United States

Countries

United States

Other Identifiers

BUP3011 and BUP3011S

Identifier Type: -

Identifier Source: org_study_id

NCT01137279

Identifier Type: -

Identifier Source: nct_alias