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

Sponsor:	Purdue Pharma LP
Information provided by:	Purdue Pharma LP
ClinicalTrials.gov Identifier:	NCT00315458

Purpose

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.

Condition	Intervention	Phase
Osteoarthritis	Drug: Buprenorphine transdermal delivery system	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Buprenorphine Buprenorphine hydrochloride

U.S. FDA Resources

Further study details as provided by Purdue Pharma LP:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Pain Right Now score

Estimated Enrollment:	310
Study Start Date:	December 2003
Estimated Study Completion Date:	February 2005

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.

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00315458

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Locations

United States, Alabama
Clinical Research Consultants
Birmingham, Alabama, United States, 35244
Winston Physician Services, Inc
Haleyville, Alabama, United States, 35565
Clinic for Rheumatic Diseases
Tuscaloosa, Alabama, United States, 35406
Parkway Medical Center
Birmingham, Alabama, United States, 35215
Private Practice
Muscle Shoals, Alabama, United States, 35661
United States, Arizona
ACRC/Arizona Clinical Research
Tuscon, Arizona, United States, 85715
Arizona Research Center
Phoenix, Arizona, United States, 85023
Radiant Research
Phoenix, Arizona, United States, 85013
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Southbay Pharma Research
Buena Park, California, United States, 90620
Torrence Clinical Research
Torrance, California, United States, 90505
United States, Florida
Gold Coast Research LLC
Weston, Florida, United States, 33321
Coastal Medical Research
Port Orange, Florida, United States, 32127
Florida Medical Research Institute
Gainesville, Florida, United States, 32605
The Arthritis Center
Palm Harbor, Florida, United States, 34684
Comprehensive Neuroscience Inc
Boynton Beach, Florida, United States, 33437
Avancia Research
Pembroke Pines, Florida, United States, 33024
University Clinical Research Deland
Deland, Florida, United States, 32720
Palm Beach Research Center
West Palm Beach, Florida, United States, 33409
Drug Study Institute
Jupiter, Florida, United States, 33458
Ormond Medical Arts Pharmaceutical Res Ctr
Ormond Beach,, Florida, United States, 32174
Chiefland Medical Center
Chiefland, Florida, United States, 32626
Coastal Medical Research
Orange City, Florida, United States, 32763
United States, Georgia
Georgia Medical Research Institute
Marietta, Georgia, United States, 30060
United States, Illinois
Internal Medicine Northwest
Gurnee, Illinois, United States, 60031
United States, Indiana
MediSphere Medical Research Center
Evansville, Indiana, United States, 47714
United States, Kentucky
University of Louisville Medical/Rheumatology
Louisville, Kentucky, United States, 40202
United States, Louisiana
Clinical Trials Management, LLC
Metairie, Louisiana, United States, 70006
United States, Massachusetts
Future Care Studies
Springfield, Massachusetts, United States, 01107
United States, Michigan
Bay Area Health Clinic
Bay City, Michigan, United States, 48706
United States, Missouri
Medex Healthcare Research Inc
St Louis, Missouri, United States, 63108
United States, New York
Beth Israel Medical Center
New York, New York, United States, 10003
United States, Oklahoma
Health Research Institute
Oklahoma City, Oklahoma, United States, 73109
United States, Pennsylvania
University Orthopedics Center
State College, Pennsylvania, United States, 16801
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
Keystone Clinical Solutions
Altoona, Pennsylvania, United States, 16602
BioMedical Research Associates
Shippensburg, Pennsylvania, United States, 17257
United States, Rhode Island
Omega Medical Research
Warwick, Rhode Island, United States, 02886
United States, South Carolina
Low Country Rheumatology
Charleston, South Carolina, United States, 29406
United States, South Dakota
Brown Clinic
Watertown, South Dakota, United States, 57201
United States, Tennessee
CSS Research
Memphis, Tennessee, United States, 38119
Prime Care Medical Center
Selmer, Tennessee, United States, 38375
Holston Medical Group
Bristol, Tennessee, United States, 37620
United States, Texas
Quality Research
San Antonio, Texas, United States, 78209
Team Research of Central Texas
Harker Heights, Texas, United States, 76548
United States, Virginia
Advanced Pain Management and Rehab Hilltop Med Center
Virginia Beach, Virginia, United States, 23454
Sentara Medical Group
Virginia Beach, Virginia, United States, 23462
United States, Washington
Physicians Clinic of Spokane
Spokane, Washington, United States, 99204

Sponsors and Collaborators

Purdue Pharma LP

More Information

No publications provided

Study ID Numbers:	BUP3011
Study First Received:	April 17, 2006
Last Updated:	April 29, 2006
ClinicalTrials.gov Identifier:	NCT00315458 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Purdue Pharma LP:

osteoarthritis
opioid
transdermal

Additional relevant MeSH terms:

Osteoarthritis
Joint Diseases
Narcotic Antagonists
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics
Rheumatic Diseases
Pharmacologic Actions
Buprenorphine

Musculoskeletal Diseases
Sensory System Agents
Therapeutic Uses
Arthritis
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on November 27, 2009