Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Mod-to-Sev Osteoarthritis Pain.

Condition(s) targeted: Osteoarthritis

Intervention: Buprenorphine transdermal delivery system (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Purdue Pharma LP

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 moderate to severe osteoarthritis pain. The double-blind treatment intervention duration is 12 weeks during which time supplemental analgesic medication (immediate release oxycodone) will be provided to all subjects in addition to study drug.

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

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: The time from first application of double-blind treatment to the development of inadequate analgesia at the primary OA pain site.

Secondary outcome: Pain Right Now score

Detailed description: Buprenorphine is a synthetic opioid analgesic with over twenty-five 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. Transdermal systems may offer advantages over currently indicated oral products including ease and convenience of use, improved compliance, possible reduction in patient care, and prolonged and consistent delivery of drug.

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

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.

Other protocol-specific exclusion/inclusion criteria may apply.

Clinical Research Consultants, Birmingham, Alabama 35244, United States

Winston Physician Services, Inc, Haleyville, Alabama 35565, United States

Clinic for Rheumatic Diseases, Tuscaloosa, Alabama 35406, United States

Parkway Medical Center, Birmingham, Alabama 35215, United States

Private Practice, Muscle Shoals, Alabama 35661, United States

ACRC/Arizona Clinical Research, Tuscon, Arizona 85715, United States

Arizona Research Center, Phoenix, Arizona 85023, United States

Radiant Research, Phoenix, Arizona 85013, United States

University of Arkansas for Medical Sciences, Little Rock, Arkansas 72205, United States

Southbay Pharma Research, Buena Park, California 90620, United States

Torrence Clinical Research, Torrance, California 90505, United States

Gold Coast Research LLC, Weston, Florida 33321, United States

Coastal Medical Research, Port Orange, Florida 32127, United States

Florida Medical Research Institute, Gainesville, Florida 32605, United States

The Arthritis Center, Palm Harbor, Florida 34684, United States

Comprehensive Neuroscience Inc, Boynton Beach, Florida 33437, United States

Avancia Research, Pembroke Pines, Florida 33024, United States

University Clinical Research Deland, Deland, Florida 32720, United States

Palm Beach Research Center, West Palm Beach, Florida 33409, United States

Drug Study Institute, Jupiter, Florida 33458, United States

Ormond Medical Arts Pharmaceutical Res Ctr, Ormond Beach,, Florida 32174, United States

Chiefland Medical Center, Chiefland, Florida 32626, United States

Coastal Medical Research, Orange City, Florida 32763, United States

Georgia Medical Research Institute, Marietta, Georgia 30060, United States

Internal Medicine Northwest, Gurnee, Illinois 60031, United States

MediSphere Medical Research Center, Evansville, Indiana 47714, United States

University of Louisville Medical/Rheumatology, Louisville, Kentucky 40202, United States

Clinical Trials Management, LLC, Metairie, Louisiana 70006, United States

Future Care Studies, Springfield, Massachusetts 01107, United States

Bay Area Health Clinic, Bay City, Michigan 48706, United States

Medex Healthcare Research Inc, St Louis, Missouri 63108, United States

Beth Israel Medical Center, New York, New York 10003, United States

Health Research Institute, Oklahoma City, Oklahoma 73109, United States

University Orthopedics Center, State College, Pennsylvania 16801, United States

Altoona Center for Clinical Research, Duncansville, Pennsylvania 16635, United States

Keystone Clinical Solutions, Altoona, Pennsylvania 16602, United States

BioMedical Research Associates, Shippensburg, Pennsylvania 17257, United States

Omega Medical Research, Warwick, Rhode Island 02886, United States

Low Country Rheumatology, Charleston, South Carolina 29406, United States

Brown Clinic, Watertown, South Dakota 57201, United States

CSS Research, Memphis, Tennessee 38119, United States

Prime Care Medical Center, Selmer, Tennessee 38375, United States

Holston Medical Group, Bristol, Tennessee 37620, United States

Quality Research, San Antonio, Texas 78209, United States

Team Research of Central Texas, Harker Heights, Texas 76548, United States

Advanced Pain Management and Rehab Hilltop Med Center, Virginia Beach, Virginia 23454, United States

Sentara Medical Group, Virginia Beach, Virginia 23462, United States

Physicians Clinic of Spokane, Spokane, Washington 99204, United States

Starting date: December 2003
Ending date: February 2005
Last updated: April 29, 2006