Buprenorphine Transdermal Patch in Subjects With Osteoarthritis Pain Requiring Opioids. Includes a 52-Week Safety Extension.

August 27, 2012 updated by: Purdue Pharma LP

Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study to Determine Efficacy and Safety of Buprenorphine Transdermal System in Subjects With Moderate To Severe Osteoarthritis Pain Requiring Daily Treatment With Opioids

The original objective of this study was to assess the safety and efficacy of the buprenorphine transdermal system (BTDS) (5, 10, and 20) in comparison to placebo transdermal system in subjects with moderate to severe osteoarthritis pain. However, this study was terminated early with only 35% of the planned sample size, therefore the primary objective is changed to focus on the safety evaluations.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Buprenorphine is a synthetic opioid analgesic with over 25 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.

Study Type

Interventional

Enrollment (Actual)

107

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
    • Alabama
      • Birmingham, Alabama, United States, 35215
        • Parkway Medical Center
      • Birmingham, Alabama, United States, 35244
        • Clinical Research Consultants
      • Haleyville, Alabama, United States, 35565
        • Winston Physician Services, Inc
      • Muscle Shoals, Alabama, United States, 35661
        • Private Practice
      • Tuscaloosa, Alabama, United States, 35406
        • Clinic for Rheumatic Diseases
    • Arizona
      • Phoenix, Arizona, United States, 85023
        • Arizona Research Center
      • Phoenix, Arizona, United States, 85013
        • Radiant Research
      • Tuscon, Arizona, United States, 85715
        • ACRC/Arizona Clinical Research
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences
    • California
      • Buena Park, California, United States, 90620
        • Southbay Pharma Research
      • Torrance, California, United States, 90505
        • Torrence Clinical Research
    • Florida
      • Boynton Beach, Florida, United States, 33437
        • Comprehensive Neuroscience Inc
      • Chiefland, Florida, United States, 32626
        • Chiefland Medical Center
      • Deland, Florida, United States, 32720
        • University Clinical Research Deland
      • Gainesville, Florida, United States, 32605
        • Florida Medical Research Institute
      • Jupiter, Florida, United States, 33458
        • Drug Study Institute
      • Orange City, Florida, United States, 32763
        • Coastal Medical Research
      • Ormond Beach,, Florida, United States, 32174
        • Ormond Medical Arts Pharmaceutical Res Ctr
      • Palm Harbor, Florida, United States, 34684
        • The Arthritis Center
      • Pembroke Pines, Florida, United States, 33024
        • Avancia Research
      • Port Orange, Florida, United States, 32127
        • Coastal Medical Research
      • West Palm Beach, Florida, United States, 33409
        • Palm Beach Research Center
      • Weston, Florida, United States, 33321
        • Gold Coast Research LLC
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Georgia Medical Research Institute
    • Illinois
      • Gurnee, Illinois, United States, 60031
        • Internal Medicine Northwest
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Medisphere Medical Research Center
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville Medical/Rheumatology
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Clinical Trials Management, LLC
    • Massachusetts
      • Springfield, Massachusetts, United States, 01107
        • Future Care Studies
    • Michigan
      • Bay City, Michigan, United States, 48706
        • Bay Area Health Clinic
    • Missouri
      • St Louis, Missouri, United States, 63108
        • Medex Healthcare Research Inc
    • New York
      • New York, New York, United States, 10003
        • Beth Israel Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73109
        • Health Research Institute
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
        • Keystone Clinical Solutions
      • Duncansville, Pennsylvania, United States, 16635
        • Altoona Center for Clinical Research
      • Shippensburg, Pennsylvania, United States, 17257
        • BioMedical Research Associates
      • State College, Pennsylvania, United States, 16801
        • University Orthopedics Center
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • Omega Medical Research
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Low Country Rheumatology
    • South Dakota
      • Watertown, South Dakota, United States, 57201
        • Brown Clinic
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • Holston Medical Group
      • Memphis, Tennessee, United States, 38119
        • CSS Research
      • Selmer, Tennessee, United States, 38375
        • Prime Care Medical Center
    • Texas
      • Harker Heights, Texas, United States, 76548
        • Team Research of Central Texas
      • San Antonio, Texas, United States, 78209
        • Quality Research
    • Virginia
      • Virginia Beach, Virginia, United States, 23462
        • Sentara Medical Group
      • Virginia Beach, Virginia, United States, 23454
        • Advanced Pain Management and Rehab Hilltop Med Center
    • Washington
      • Spokane, Washington, United States, 99204
        • Physicians Clinic Of Spokane

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

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • clinical evidence of osteoarthritis of the hip, knee, or spine joint for ≥ 1 year currently adequately treated with short acting opioids.
  • taking ≥ 30 and ≤ 80 mg oral morphine or morphine equivalents per day for ≥ 2 weeks for control of their osteoarthritis pain.

Exclusion Criteria:

  • requiring frequent analgesic therapy for chronic condition(s), other than osteoarthritis of the hip, knee, or spine.
  • scheduled for surgery of the disease site (e.g., major joint replacement surgery), or any other major surgery that would fall within the study period.

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BTDS
Buprenorphine transdermal patches 10 or 20 mcg/h
Drug: Buprenorphine transdermal patch
Buprenorphine transdermal patch applied for 7-day wear.
Other Names:
  • Butrans™
Placebo Comparator: Placebo
Placebo to match buprenorphine transdermal patch 10 or 20
Drug: Placebo transdermal patch
Placebo to match buprenorphine transdermal patch 10 or 20.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events (AEs) as a Measure of Safety
Time Frame: 483 days
For the Run-in and double-blind phases of the study, the focus of this study was changed before unblinding to a safety study due to early termination and having enrolled only 35% of the planned sample size. Therefore, the safety data is presented for the run-in and double-blind and overall exposure to BTDS, which includes the extension phase.
483 days

Collaborators and Investigators

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

Sponsor

Purdue Pharma LP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

December 1, 2003

Primary Completion (Actual)

March 1, 2005

Study Completion (Actual)

March 1, 2005

Study Registration Dates

First Submitted

April 17, 2006

First Submitted That Met QC Criteria

April 17, 2006

First Posted (Estimate)

April 18, 2006

Study Record Updates

Last Update Posted (Estimate)

September 3, 2012

Last Update Submitted That Met QC Criteria

August 27, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BUP3011 and BUP3011S

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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