Buprenorphine Transdermal Patches (BTDS) in Subjects With Osteoarthritis Pain. Includes a 52-week Extension Phase.

August 27, 2012 updated by: Purdue Pharma LP

A Randomized, Double-Blind, Multicenter Study Evaluating The Safety and Efficacy of BTDS in Subjects With Moderate to Severe Osteoarthritis Pain. Includes a 52-Week Extension Phase.

The original objective of this study was to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) 20 micrograms (mcg)/hour (h) in comparison to the buprenorphine transdermal system 5 mcg/h in subjects with moderate to severe osteoarthritis pain currently treated with oral opioids. The double-blind treatment intervention duration is 12 weeks during which time supplemental analgesic medication (acetaminophen or ibuprofen) will be provided to all subjects in addition to study drug.

This study was terminated early due to administrative reasons with only 20% of the planned sample size; therefore, the primary objective was changed to focus on the safety evaluation.

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)

188

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, 35235
        • Edwards Lake Medical Center
      • Birmingham, Alabama, United States, 35215
        • Parkway Medical Center
      • Huntsville, Alabama, United States, 35801
        • Rheumatogogy Associates of N. Alabama,
      • Montgomery, Alabama, United States, 36106
        • Drug Research and Analysis Corp.
    • Arizona
      • Scottsdale, Arizona, United States, 85251
        • Meadowbrook Research
      • Searcy, Arizona, United States, 72143
        • Research Solutions, LLC
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Central Arkansas Research
    • California
      • Anaheim, California, United States, 92805
        • NuLife Clinical Research, Inc.
      • Anaheim, California, United States, 92804
        • Crest Clinical Research, Inc
      • Cypress, California, United States, 90630
        • Orange County Clinical Research
      • Laguna Hills, California, United States, 90404
        • Private Practice
      • Laguna Niguel, California, United States, 92677
        • Andwell Research
      • Long Beach, California, United States, 90802
        • Valerius Medical Group & Research Center Inc.
      • Los Gatos, California, United States, 95032
        • Anesthesiology and Pain Management
      • San Diego, California, United States, 92128
        • Scripps Clinic Ranchro Bernardo
      • Santa Monica, California, United States, 90404
        • Orrin M. Troum & Medical Associates
      • Walnut Creek, California, United States, 94598
        • Diablo Clinical Research
    • Colorado
      • Arvada, Colorado, United States, 80005
        • Private Practice
      • Denver, Colorado, United States, 80209
        • Mountainview Clinical Research
    • Florida
      • Aventura, Florida, United States, 33180
        • Private Practice
      • Clearwater, Florida, United States, 33761
        • Medical Research Associates
      • Miami, Florida, United States, 33186
        • Lifespan Clinical Research
      • Ocala, Florida, United States, 34474
        • Ocala Rheumatology Research Center
      • Sarasota, Florida, United States, 34239
        • Sarasota Arthritis Center
      • Sarasota, Florida, United States, 34243
        • University Neurology
      • St. Cloud, Florida, United States, 34769
        • Wilker/Powers Center for Clinical Studies
      • St. Cloud, Florida, United States, 34769
        • Family Practice of St. Cloud PA Wilker/Powers Center for Clinical Studies
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Pinnacle Trials, Inc.
      • Augusta, Georgia, United States, 30912
        • Clinical Investigative Services Med College of Georgia
    • Illinois
      • Gurnee, Illinois, United States, 60031
        • America's Doctor (SMO)
    • Louisiana
      • New Orleans, Louisiana, United States, 70128
        • Dolby Providers, Inc.
    • Michigan
      • Cadillac, Michigan, United States, 49601
        • Professional Clinical Research
      • Oak Park, Michigan, United States, 48237
        • Private Practice
      • St. Joseph, Michigan, United States, 49085
        • Lake Michigan Clinical Research and Consulting, Inc.
    • Missouri
      • Everton, Missouri, United States, 65646
        • Research Center of the Ozarks, , MO
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Comprehensive Clinical Research
      • Cherry Hill, New Jersey, United States, 08002
        • Cherry Hill Orthopedic Surgeons
      • Medford, New Jersey, United States, 08055
        • Private Practice
      • Stratford, New Jersey, United States, 08084
        • Univeristy of Medicine and Dentistry of New Jersey
    • New York
      • Astoria, New York, United States, 11102
        • Crescent Medical Assoc.
      • Plainview, New York, United States, 11803
        • Private Practice
      • Stonybrook, New York, United States, 11794
        • State University of NY at Stonybrook
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Charlotte Spine Center Pain and Orthopedic Neurology, Pain Research Institute of the Carolinas
      • Elizabeth City, North Carolina, United States, 27909
        • Albermarle Family Practice
      • Wilmington, North Carolina, United States, 28412
        • New Hanover Medical Research
    • North Dakota
      • Bismark, North Dakota, United States, 58501
        • Odyssey Research Services
    • Ohio
      • Bellbrook, Ohio, United States, 45305
        • Midwest Regional Research
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • COR Clinical Research, LLC
      • Tulsa, Oklahoma, United States, 74104
        • Lyle, Austin Alexander PA
    • Oregon
      • Medford, Oregon, United States, 97504
        • Southern Oregon Health & Wellness
      • Medford, Oregon, United States, 97504
        • Rouge Valley Clinical Research
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
        • Keystone Clinical Solutions, Inc.
      • Philadelphia, Pennsylvania, United States, 19142
        • Arcuri Clinical Research
      • Philadelphia, Pennsylvania, United States, 19103
        • Sidney Hillman Medical Center
    • South Carolina
      • Orangeburg, South Carolina, United States, 29118
        • The Arthritis & Osteoporosis Center
    • Tennessee
      • Clarksville, Tennessee, United States, 37043
        • Alpha Clinical Research
      • Kingsport, Tennessee, United States, 37660
        • Holston Medical Group
      • Milan, Tennessee, United States, 38358
        • Integrity Clinical Research, LLC (SMO)
    • Utah
      • Salt Lake City, Utah, United States, 84106
        • LifeTree Clinical Reseach
      • Salt Lake City, Utah, United States, 84109
        • J. Lewis Research Foothill Family Clinic
      • Salt Lake City, Utah, United States, 84121
        • J. Lewis Research Foothill Family Clinic South
    • Virginia
      • Arlington, Virginia, United States, 22205
        • Arthritis Clinic of No. Virginia
      • Richmond, Virginia, United States, 23229
        • MedSource
    • Washington
      • Lacey, Washington, United States, 98516
        • Vantage Clinical Research Group
      • Seattle, Washington, United States, 98166
        • Arthritis Northwest
      • Yakima, Washington, United States, 98902
        • Clinical Trials Northwest

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:

  • osteoarthritis of the hip, knee, or spine for 1 year or longer.
  • taking between 30-80 milligrams (mg) of oral morphine sulfate or equivalent/day, at least 4 days a week.

Exclusion Criteria:

  • taking more than 80 mg per day of oral morphine sulfate or equivalent within 30 days of enrollment.
  • requiring frequent analgesic therapy for chronic conditions in addition to osteoarthritis.

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: BTDS 5
Buprenorphine transdermal patch 5 mcg/h, applied for 7-day wear
Drug: Buprenorphine transdermal patch
Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
Other Names:
  • Butrans™
Drug: Buprenorphine transdermal patch
Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
Other Names:
  • Butrans™
EXPERIMENTAL: BTDS 20
Buprenorphine transdermal patch 20 mcg/h, applied for 7-day wear
Drug: Buprenorphine transdermal patch
Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
Other Names:
  • Butrans™
Drug: Buprenorphine transdermal patch
Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
Other Names:
  • Butrans™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Number of Participants With Adverse Events (AEs) as a Measure of Safety.
Time Frame: Throughout BTDS exposure (Includes run-in period, double-blind phase and extension phase)
Safety assessments included monitoring and recording of all adverse events and serious adverse events (SAEs).
Throughout BTDS exposure (Includes run-in period, double-blind phase and extension phase)

Collaborators and Investigators

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

Sponsor

Purdue Pharma LP

Investigators

  • Study Chair: Sarah O'Keefe, BSN, Purdue Pharma L.P., Stamford, CT

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

January 1, 2004

Primary Completion (ACTUAL)

March 1, 2005

Study Completion (ACTUAL)

March 1, 2005

Study Registration Dates

First Submitted

April 28, 2006

First Submitted That Met QC Criteria

April 28, 2006

First Posted (ESTIMATE)

May 3, 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

  • BUP3014 and BUP3014S

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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