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

Sponsored by:	Purdue Pharma LP
Information provided by:	Purdue Pharma LP
ClinicalTrials.gov Identifier:	NCT00314652

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

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

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Buprenorphine Buprenorphine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Double-Blind Placebo-Controlled Study of Buprenorphine Transdermal System (BTDS) in Patients With Osteoarthritis of the Hip or Knee

Further study details as provided by Purdue Pharma LP:

Primary Outcome Measures:

Percentage of patients who were treated successfully for pain management
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:

Average pain intensity and patient satisfaction scores
Incidence of early discontinuation due to lack of efficacy
Time to early discontinuation due to lack of efficacy
Dose level at end of titration
Investigator’s assessment of therapeutic response
Diary pain scores

Estimated Enrollment:	260
Study Start Date:	June 1999
Estimated Study Completion Date:	October 1999

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

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00314652

Locations

United States, Arizona
ACRC/Arizona Clinical Research
Tucson, Arizona, United States, 85712
Arizona Research Center, LLC
Phoenix, Arizona, United States, 85023
Advanced Clinical Therapeutics
Tucson, Arizona, United States, 85712
Hawthorne & York, International, Ltd.
Phoenix, Arizona, United States, 85008
United States, California
Scripps Clinic Rancho Bernardo
San Diego, California, United States, 92128
San Diego Arthritis and Osteoporosis Research
San Diego, California, United States, 92120
United States, Connecticut
Clinical Research Consultants, Inc.
Trumbull, Connecticut, United States, 06611
United States, Florida
Gold Coast Research, Inc.
Weston, Florida, United States, 33331
Gainesville Clinical Research Center
Gainesville, Florida, United States, 32605
University Clinical Research, Inc.
Pembroke Pines, Florida, United States, 33024
Tampa Bay Medical Research, Inc.
Clearwater, Florida, United States, 33761
Physicians Research Associates Jacksonville
Jacksonville, Florida, United States, 32216
University Clinical Research
Deland, Florida, United States, 32720
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

More Information

Study ID Numbers:	BP99-0203
Study First Received:	April 12, 2006
Last Updated:	April 29, 2006
ClinicalTrials.gov Identifier:	NCT00314652
Health Authority:	United States: Food and Drug Administration

Keywords provided by Purdue Pharma LP:

Osteoarthritis
chronic pain
opioid
transdermal

Study placed in the following topic categories:

Buprenorphine
Musculoskeletal Diseases
Osteoarthritis
Joint Diseases

Arthritis
Pain
Rheumatic Diseases
Osteoarthritis, Hip

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 January 16, 2009