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

April 29, 2006 updated by: Purdue Pharma LP

A Double-Blind Placebo-Controlled Study of Buprenorphine Transdermal System (BTDS) in Patients With Osteoarthritis of the Hip or Knee

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

260

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Purdue Pharma LP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 1999

Study Completion

October 1, 1999

Study Registration Dates

First Submitted

April 12, 2006

First Submitted That Met QC Criteria

April 12, 2006

First Posted (Estimate)

April 14, 2006

Study Record Updates

Last Update Posted (Estimate)

May 3, 2006

Last Update Submitted That Met QC Criteria

April 29, 2006

Last Verified

April 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BP99-0203

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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