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

This study has been terminated.

Sponsored by: 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

MedlinePlus related topics:   Osteoarthritis   

Drug Information available for:   Oxycodone    Oxycodone hydrochloride    Buprenorphine    Buprenorphine hydrochloride   

U.S. FDA Resources

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

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


Study ID Numbers:   BUP3019
First Received:   April 6, 2006
Last Updated:   April 29, 2006
ClinicalTrials.gov Identifier:   NCT00312221
Health Authority:   United States: Food and Drug Administration

Keywords provided by Purdue Pharma LP:
Osteoarthritis, opioid, transdermal  

Study placed in the following topic categories:
Buprenorphine
Musculoskeletal Diseases
Osteoarthritis
Joint Diseases
Arthritis
Oxycodone
Pain
Rheumatic Diseases

Additional relevant MeSH terms:
Sensory System Agents
Therapeutic Uses
Narcotic Antagonists
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Pharmacologic Actions
Analgesics, Opioid

ClinicalTrials.gov processed this record on November 20, 2008




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