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

This study has been completed.
Sponsor:
Information provided by:
Purdue Pharma LP
ClinicalTrials.gov Identifier:
NCT00314652
First received: April 12, 2006
Last updated: April 29, 2006
Last verified: April 2006
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


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
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, see Learn About Clinical Studies.

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

Locations
United States, Arizona
Arizona Research Center, LLC
Phoenix, Arizona, United States, 85023
Hawthorne & York, International, Ltd.
Phoenix, Arizona, United States, 85008
ACRC/Arizona Clinical Research
Tucson, Arizona, United States, 85712
Advanced Clinical Therapeutics
Tucson, Arizona, United States, 85712
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
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
  More Information

No publications provided

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

Keywords provided by Purdue Pharma LP:
Osteoarthritis
chronic pain
opioid
transdermal

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Buprenorphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Narcotic Antagonists

ClinicalTrials.gov processed this record on August 28, 2014