Safety and Efficacy of Buprenorphine Transdermal System in Subjects With Moderate to Severe Osteoarthritis of Hip or Knee

August 27, 2012 updated by: Purdue Pharma LP

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of the Buprenorphine Transdermal Delivery System in Subjects With Moderate to Severe Osteoarthritic Pain of Hip or Knee

The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) (5, 10 and 20) in comparison to placebo transdermal system in subjects with moderate to severe osteoarthritis pain of the hip and knee currently treated with oral opioids. The double-blind treatment intervention duration is 4 weeks during which time supplemental analgesic medication (acetaminophen) will be provided to all subjects in addition to study drug.

Study Overview

Status

Completed

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)

529

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
      • Mesa, Arizona, United States, 85206
        • Vista Medical Research
      • Phoenix, Arizona, United States, 85023
        • Arizona Research Center
      • Phoenix, Arizona, United States, 85013
        • Radiant Research
      • Phoenix, Arizona, United States, 85012
        • Arizona Research Center
      • Tucson, Arizona, United States, 85715
        • ACRC/Arizona Clinical Research
    • California
      • Bakersfield, California, United States, 93311
        • Advance Pain Medicine
      • Cypress, California, United States, 90623
        • Eastgate Medical Center
      • Loma Linda, California, United States, 92354
        • University Osteoporosis Ctr
      • San Diego, California, United States, 92108
        • San Diego Arthritis & Osteoporosis Medical Clinic
      • San Diego, California, United States, 92128
        • Scripps Clinic Rancho Bernard
      • San Francisco, California, United States, 94121
        • CNS Clinical Trials, Inc
    • Colorado
      • Denver, Colorado, United States, 80209
        • Mountain View Clinical Research
      • Westminster, Colorado, United States, 80021
        • Integrative Treatment Centers/Rocky Mtn Clin Res
      • Wheat Ridge, Colorado, United States, 80033
        • Rocky Mountain Center for Clinical Research
    • Connecticut
      • Bridgeport, Connecticut, United States, 66060
        • Stamford Therapeutic Consortium
    • Florida
      • Atlantis, Florida, United States, 33462
        • Medical Specialists of the Palm Beaches
      • Deland, Florida, United States, 32720
        • University Clinical Research Deland
      • Jupiter, Florida, United States, 33458
        • Drug Study Institute
      • Orange City, Florida, United States, 32763
        • Coastal Medical Research
      • Port Orange, Florida, United States, 32127
        • Coastal Medical Research
      • W. Palm Beach, Florida, United States, 33409
        • Palm Beach Research Center
      • Weston, Florida, United States, 33331
        • Gold Coast Research
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Non-Surgical Orthopedic & Spine Center
    • Indiana
      • Columbus, Indiana, United States, 47201
        • Columbus Internal Medical Associates
      • Evansville, Indiana, United States, 47714
        • MediSphere Medical Research Ctr.
    • Kentucky
      • Murray, Kentucky, United States, 42071
        • Primary Care Research
    • Michigan
      • Cadillac, Michigan, United States, 49601
        • Professional Clinical Research
      • Traverse City, Michigan, United States, 49684
        • Sound Medical At West Front Primary Care
    • New York
      • New York, New York, United States, 10003
        • Beth Israel Med Ctr Dept of Pain Medicine & Palliative Care
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • All-Trials Clinical Research, LLC
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
        • Keystone Clinical
      • Duncansville, Pennsylvania, United States, 16635
        • Altoona Center For Clinical Research
      • State College, Pennsylvania, United States, 16801
        • University Orthopedics Center
      • West Reading, Pennsylvania, United States, 19611
        • Clinical Research Center of Reading, LLP
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Low Country Rheumatology
    • South Dakota
      • Watertown, South Dakota, United States, 57201
        • Brown Clinic
    • Texas
      • Dallas, Texas, United States, 75251
        • Private Practice
      • Harker Heights, Texas, United States, 76548
        • Team Research of Central Texas
      • San Antonio, Texas, United States, 78217
        • Radiant Research San Antonio Northeast
      • Seguin, Texas, United States, 78155
        • ACCU Clinical Research Trials, Inc
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Wasatch Clinical Research
    • Virginia
      • Virgina Beach, Virginia, United States, 23454
        • Advance Pain Management & Rehab
    • Washington
      • Edmonds, Washington, United States, 98026
        • Evergreen Clinical Research Associates
      • Tacoma, Washington, United States, 98405
        • Internal Medicine 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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • clinical diagnosis of chronic osteoarthritis of the hip or knee for 1 year or longer.
  • an average pain due to osteoarthritis of moderate, moderately-severe, or severe for the 14 days prior to enrollment.

Exclusion Criteria:

  • ingest opioid analgesics on a daily basis.
  • ingest >2500 milligrams (mg) acetaminophen on a daily basis.
  • require <20 mg or >80 mg of morphine (or opioid equivalents) per day for control of their osteoarthritis pain.

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 patch 5, 10 or 20 micrograms/hour (mcg/h)
Drug: Buprenorphine transdermal patch
Buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear.
Other Names:
  • Butrans™
Placebo Comparator: Placebo
Placebo to match BTDS 5, 10 or 20 mcg/h
Drug: Placebo
Placebo to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Time (Days) From First Administration of Double-blind Treatment to the Development of Inadequate Analgesia at the Primary Osteoarthritis Pain Site.
Time Frame: Double-blind phase ( 28 days): reaching "inadequate analgesia" on any 2 days of the 7-day dosing periods

Inadequate analgesia:

  • "average pain over the last 24 hours" score for pain at primary osteoarthritis (OA) site ≥ 5 on any 2 days of any 7-day dosing period, on a scale from 0 - 10 (0 = no pain to 10 = pain as bad as you can imagine)or;
  • >1000 mg/day acetaminophen for pain at primary OA site for ≥ 2 days in any 7-day dosing period, or;
  • ingested nonstudy opioid analgesic medication for pain at primary OA site. Score: lowest score = shortest time to inadequate analgesia; highest score = longest time to inadequate analgesia.
Double-blind phase ( 28 days): reaching "inadequate analgesia" on any 2 days of the 7-day dosing periods

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Daily Maximum "Pain Right Now" Score for the Primary Osteoarthritis (OA) Pain Site
Time Frame: 7 days of the last dosing period of the double-blind phase, or the last 7-day dosing period prior to emergence of inadequate analgesia or discontinuation from the double-blind phase.
The daily maximum 'pain right now' score for the primary OA pain site was calculated over the last 7-day dosing period in the double-blind phase or the last 7-day dosing period prior to emergence of inadequate analgesia or discontinuation from the double-blind phase. Collected prior to ingestion of acetaminophen. "Pain right now" scale score for primary OA site on a scale from 0-10 (where 0= no pain and 10= worst pain you can imagine).
7 days of the last dosing period of the double-blind phase, or the last 7-day dosing period prior to emergence of inadequate analgesia or discontinuation from the double-blind phase.

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

April 1, 2003

Primary Completion (Actual)

June 1, 2004

Study Completion (Actual)

June 1, 2004

Study Registration Dates

First Submitted

April 11, 2006

First Submitted That Met QC Criteria

April 11, 2006

First Posted (Estimate)

April 12, 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

  • BUP3012

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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