Safety and Efficacy of 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:	NCT00312221

Purpose

The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (20 mg) in comparison to the buprenorphine transdermal system (5 mg) and oxycodone immediate release in subjects with moderate to severe osteoarthritis pain currently treated with oral opioids. The double-blind treatment intervention duration is 12 weeks during which time supplemental analgesic medication (acetaminophen, ibuprofen, 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, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Randomized, Double-Blind, Multicenter, Active Comparator Study to Determine the Efficacy and Safety of BTDS 20 or OxyIR Versus BTDS 5 in Subjects With Moderate to Severe Osteoarthritis (OA) Pain

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:

Average pain over the last 24 hours score at Weeks 4, 8, and 12.

Secondary Outcome Measures:

Average pain and worst pain scores, supplemental analgesic medication use.

Estimated Enrollment:	858
Study Start Date:	April 2004
Estimated Study Completion Date:	August 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:

Osteoarthritis of the hip, knee, or spine for 1 year or longer, confirmed by radiographic evidence within the last 2 years.
Good pain control while on a stable dose of an opioid analgesic for osteoarthritis.

Exclusion Criteria:

Not currently taking and tolerating opioids.
Taking more than 80 mg per day of oral morphine sulfate or equivalent within 30 days of enrollment.
Requiring frequent analgesic therapy for chronic condition(s), in addition to osteoarthritis.

Other protocol-specific exclusion/inclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00312221

Locations

United States, Alabama
Parkway Medical Center
Birmingham, Alabama, United States, 35215
United States, California
Torrance Clinical Research
Torrance, California, United States, 90505
International Clinical Research Network
Chula Vista, California, United States, 91910
Accelovance
San Diego, California, United States, 92108
Clinical Trials Research
Roseville, California, United States, 95661
United States, Colorado
Southern Colorado Clinic
Pueblo, Colorado, United States, 81008
United States, Florida
Palm Beach Research Center
West Palm Beach, Florida, United States, 33409
Drug Study Institute
Jupiter, Florida, United States, 33458
Peninsula Research, Inc.
Ormond Beach, Florida, United States, 32174
Innovative Research of West Florida, Inc.
Largo, Florida, United States, 33770
International Medical Research
Ormond Beach, Florida, United States, 32174
United States, Georgia
Georgia Medical Research Institute
Marietta, Georgia, United States, 30060
Non- Surgical Orthopedic & Spine Center, P.C.
Marietta, Georgia, United States, 30060
United States, Illinois
The Arthritis Center
Springfield, Illinois, United States, 62704
United States, Kentucky
Commonwealth Biomedical Research, LLC
Madisonville, Kentucky, United States, 42431
United States, Massachusetts
Miray Medical Center
Brockton, Massachusetts, United States, 23010
United States, Michigan
Professional Clinical Research Crystal Lake Health Center
Benzonia, Michigan, United States, 49616
Rheumatology PC
Kalamazoo, Michigan, United States, 49009
United States, North Carolina
Pharm Quest
Greensboro, North Carolina, United States, 27401
United States, Pennsylvania
The Clinical Trial Center, LLC
Jenkintown, Pennsylvania, United States, 19046
United States, Texas
Texas Medical Research Associates
San Antonio, Texas, United States, 78238
Amarillo Center for Clinical Research
Amarillo, Texas, United States, 79124
Med Search Professional Group/Pharmaceutical C-Trials Inc.
Hurst, Texas, United States, 76054

Sponsors and Collaborators

Purdue Pharma LP

More Information

No publications provided

Study ID Numbers:	BUP3019
Study First Received:	April 6, 2006
Last Updated:	April 29, 2006
ClinicalTrials.gov Identifier:	NCT00312221 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 February 08, 2010