Safety of BTDS in Subjects With Osteoarthritic (OA) Pain of Hip or Knee: A 6-Month Open-label Extension Phase

August 27, 2012 updated by: Purdue Pharma LP

Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study of the Efficacy and Safety of Buprenorphine Transdermal System (BTDS) in Subjects With Mod to Sev OA Pain of Hip or Knee: A 6-Month Open-label Extension Phase

The purpose of the extension phase is to evaluate the long-term safety and tolerability of buprenorphine transdermal system (BTDS).

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. 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 (Actual)

290

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 Inc.
      • Phoenix, Arizona, United States, 85023
        • Arizona Research Center
      • Phoenix, Arizona, United States, 85012
        • Arthrocare, Arthritis Care and Research
      • Phoenix, Arizona, United States, 85015
        • Arizona Rheumatology Ctr and Phoenix Ctr for Clinical Research
      • Tucson, Arizona, United States, 85712
        • Research Facility
    • California
      • Bakersfield, California, United States, 93311
        • Advanced Pain Medicine
      • Cypress, California, United States, 90630
        • Orange County Clinical Research
      • San Diego, California, United States, 92120
        • San Diego Arthritis & Osteoporosis Medical Clinic
      • San Diego, California, United States, 92128
        • Research Facility
      • San Francisco, California, United States, 94121
        • Research Facility
    • Colorado
      • Denver, Colorado, United States, 80209
        • Research Facility
      • Westminster, Colorado, United States, 80031
        • Research Facility
    • Connecticut
      • Bridgeport, Connecticut, United States, 06606
        • Research Facility
    • Florida
      • Atlantis, Florida, United States, 33462
        • Research Facility
      • Daytona Beach, Florida, United States, 32114
        • Allergy, Asthma, Arthritis & Lung
      • Deland, Florida, United States, 32720
        • University Clinical Research Deland
      • Jupiter, Florida, United States, 33458
        • Research Facility
      • Orange City, Florida, United States, 32763
        • Coastal Medical Research
      • Plantation, Florida, United States, 33324
        • Research Facility
      • West Palm Beach, Florida, United States, 33409
        • Research Facility
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Research Facility
    • Indiana
      • Columbus, Indiana, United States, 47201
        • Research Facility
      • Evansville, Indiana, United States, 47712
        • Research Facility
    • Kentucky
      • Murray, Kentucky, United States, 42071
        • Primary Care Medical Center
    • Michigan
      • Cadillac, Michigan, United States, 49601
        • Great Lakes Family Care
      • Traverse City, Michigan, United States, 49684
        • Research Facility
    • New York
      • New York, New York, United States, 10021
        • Beth Israel/Dept. of Pain
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Research Facility
    • Pennsylvania
      • Cresson, Pennsylvania, United States, 16630
        • Research Facility
      • Duncansville, Pennsylvania, United States, 16635
        • Altoona Center For Clinical Research
      • State College, Pennsylvania, United States, 16801
        • University Orthopedics & Sport Medicine Center
      • West Reading, Pennsylvania, United States, 19611
        • Research Facility
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Low Country Rheumatology, PA
    • South Dakota
      • Watertown, South Dakota, United States, 57201
        • Central Plains Clin-Brown Site
    • Texas
      • Dallas, Texas, United States, 75251
        • Research Facility
      • Harker Heights, Texas, United States, 76548
        • Research Facility
      • San Antonio, Texas, United States, 78217
        • Research Facility
      • Seguin, Texas, United States, 78155
        • Research Facility
    • Utah
      • West Valley City, Utah, United States, 84120
        • Granger Medical Clinic
    • Virginia
      • Virginia Beach, Virginia, United States, 23454
        • Hilltop Medical Center
    • Washington
      • Bellevue, Washington, United States, 98026
        • Research Facility
      • 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:

  • Subjects with moderate to severe osteoarthritic (OA) pain who completed all visits of the double-blind phase on study drug, or who discontinued study drug due to lack of therapeutic effect in the double-blind phase, but still completed all visits of the double-blind phase off study drug, are eligible to enroll in the extension phase.

Exclusion Criteria:

  • Excluded from the study are subjects who ingest > 2500 mg/day acetaminophen as part of their current stable nonopioid analgesic regimen.
  • Subjects requiring long-acting opioid analgesics [once- or twice-daily dosing with an every (q) 24 hour (h) or q12h drug] or transdermal fentanyl during the extension phase should be discontinued from the study.

Refer to core study for additional inclusion/exclusion information.

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BTDS
Buprenorphine transdermal patch
Drug: Buprenorphine transdermal patch
Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
Drug: Buprenorphine transdermal patch
Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
Drug: Buprenorphine transdermal patch
Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time Frame: 6 months.
Safety was assessed using reports of adverse events, clinical laboratory results, findings from physical examinations, and vital sign measurements.
6 months.

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)

July 1, 2004

Study Completion (Actual)

July 1, 2004

Study Registration Dates

First Submitted

June 2, 2010

First Submitted That Met QC Criteria

June 9, 2010

First Posted (Estimate)

June 10, 2010

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

  • BUP3012S

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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