Working... Menu

Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Osteoarthritis Pain.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00314652
Recruitment Status : Completed
First Posted : April 14, 2006
Last Update Posted : May 3, 2006
Information provided by:
Purdue Pharma LP

Brief Summary:
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 osteoarthritis pain. The double-blind treatment intervention duration is 28 days.

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: Buprenorphine transdermal delivery system Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Double-Blind Placebo-Controlled Study of Buprenorphine Transdermal System (BTDS) in Patients With Osteoarthritis of the Hip or Knee
Study Start Date : June 1999
Study Completion Date : October 1999

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Primary Outcome Measures :
  1. Percentage of patients who were treated successfully for pain management
  2. a patient fails if he or she discontinues early due to ineffective treatment or has a Patient Satisfaction Scale score of poor or fair at the final visit

Secondary Outcome Measures :
  1. Average pain intensity and patient satisfaction scores
  2. Incidence of early discontinuation due to lack of efficacy
  3. Time to early discontinuation due to lack of efficacy
  4. Dose level at end of titration
  5. Investigator’s assessment of therapeutic response
  6. Diary pain scores

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • documented history and/or radiologic evidence of chronic osteoarthritis of the hip or knee.
  • receiving opioid therapy for osteoarthritis-related pain within the past year or have experienced pain that was inadequately controlled with a full standard dose of NSAIDs.

Exclusion Criteria:

  • receiving opioids at an average daily dose of greater than 90 mg of oral morphine equivalents or patients receiving more than 12 tablets or capsules per day of short-acting opioid-containing products
  • scheduled to have surgery (including dental) during the study period that involved the use of pre- and/or postoperative analgesics or anesthetics.

Other protocol-specific exclusion/inclusion criteria may apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00314652

Layout table for location information
United States, Arizona
Hawthorne & York, International, Ltd.
Phoenix, Arizona, United States, 85008
Arizona Research Center, LLC
Phoenix, Arizona, United States, 85023
ACRC/Arizona Clinical Research
Tucson, Arizona, United States, 85712
Advanced Clinical Therapeutics
Tucson, Arizona, United States, 85712
United States, California
San Diego Arthritis and Osteoporosis Research
San Diego, California, United States, 92120
Scripps Clinic Rancho Bernardo
San Diego, California, United States, 92128
United States, Connecticut
Clinical Research Consultants, Inc.
Trumbull, Connecticut, United States, 06611
United States, Florida
Tampa Bay Medical Research, Inc.
Clearwater, Florida, United States, 33761
University Clinical Research
Deland, Florida, United States, 32720
Gainesville Clinical Research Center
Gainesville, Florida, United States, 32605
Physicians Research Associates Jacksonville
Jacksonville, Florida, United States, 32216
University Clinical Research, Inc.
Pembroke Pines, Florida, United States, 33024
Gold Coast Research, Inc.
Weston, Florida, United States, 33331
United States, Indiana
MediSphere Medical Research Center, LLC
Evansville, Indiana, United States, 47714
United States, Michigan
Westside Family Medical Center
Kalamazoo, Michigan, United States, 49009
United States, Missouri
Center for Pharmaceutical Research
Kansas City, Missouri, United States, 64114
United States, New Jersey
NJP Clinical Research
Passaic, New Jersey, United States, 07055
United States, North Carolina
PW Clinical Research, LLC
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
New Century Research Center, Ltd.
Beaverbrook, Ohio, United States, 45431
United States, Pennsylvania
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
United States, Tennessee
Mid-South Clinical Research Institute
Memphis, Tennessee, United States, 38120
United States, Utah
Advanced Clinical Research
Salt Lake City, Utah, United States, 84102
Sponsors and Collaborators
Purdue Pharma LP

Layout table for additonal information Identifier: NCT00314652     History of Changes
Other Study ID Numbers: BP99-0203
First Posted: April 14, 2006    Key Record Dates
Last Update Posted: May 3, 2006
Last Verified: April 2006

Keywords provided by Purdue Pharma LP:
chronic pain

Additional relevant MeSH terms:
Layout table for MeSH terms
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists