Safety of Buprenorphine Transdermal Systems in Subjects With Chronic Nonmalignant Pain - a 28-week Extension Study

September 5, 2012 updated by: Purdue Pharma LP

An Open-Label, Multi-Center, Titration Study to Establish the Long-term Safety and Tolerability of Buprenorphine Transdermal Delivery System (BTDS) 5 mg, 10 mg, and 20 mg in Patients With Chronic Non-Malignant Pain Syndromes Responsive to Opioid Combination Therapy - a 28-Week Extension Study.

The objective of this study was to evaluate the long-term safety and tolerability of 7-day BTDS in a 28-week open-label extension phase in subjects with chronic nonmalignant pain syndromes whose pain had been previously controlled by oral opioid combination therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Upon entering the extension phase (BUP3201S), subjects will receive BTDS 5, regardless of their dose level at discontinuation or completion of the BUP3201 core study. Subjects are allowed to titrate after 48 hours to BTDS 10 or 20 that provided stable pain control with minimal tolerability problems. Additional medical therapies are permitted if necessary, and there is no restriction on concomitant analgesic medications. The subjects have weekly visits for 4 consecutive weeks, and every 4 weeks thereafter, until the end of the scheduled extension phase.

Study Type

Interventional

Enrollment (Actual)

189

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, 85023
        • Arizona Research Center Inc.
    • Connecticut
      • Trumbull, Connecticut, United States, 06611
        • Clinical Research Consultants Inc
    • Florida
      • Clearwater, Florida, United States, 33761
        • Tampa Bay Medical Research Inc
      • Coral Gables, Florida, United States, 33134
        • Clinical Research of South Florida
      • Deland, Florida, United States, 32720
        • University Clinical Research Deland
      • Pembroke Pines, Florida, United States, 33024
        • University Clinical Research Inc,
      • Plantation, Florida, United States, 33324
        • Gold Coast Research, LLC
      • Tamarac, Florida, United States, 33321
        • Gold Coast Research LLC
    • Indiana
      • Evansville, Indiana, United States, 47712
        • Family Medicine Associates
      • Terre Haute, Indiana, United States, 47807
        • Pain Management & Rehabilitation
    • Kentucky
      • Crestview Heights, Kentucky, United States, 41017
        • Southeastern Center for Headache and Pain
    • Michigan
      • Kalamazoo, Michigan, United States, 49009
        • Westside Family Medical Center PC
    • North Carolina
      • Charlotte, North Carolina, United States, 28211
        • The Arthritis Clinic
      • High Point, North Carolina, United States, 27262
        • Cornerstone Research Care
      • Winston-Salem, North Carolina, United States, 27103
        • ALL-TRIALS Clinical Research LLC
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Summit Research Solutions
    • Texas
      • Austin, Texas, United States, 78758
        • Radiant Research - Austin
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Wasatch Clinical Research
    • Wisconsin
      • New Berlin, Wisconsin, United States, 53151
        • Clinical Research Management

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:

Include:

  • Subjects of either sex aged 18 years or older.
  • Subjects who have completed or discontinued the double-blind evaluation phase of study BUP3201 are eligible to continue to receive open-label BTDS in the extension.

Exclusion Criteria:

Include:

  • Subjects currently receiving daily morphine or oxycodone (mono-therapy).
  • Subjects who are discontinued from BUP3201 due to adverse events.
  • Subjects who are scheduled for surgery of the disease site (e.g. major joint replacement surgery) or any other major surgery which would fall within the study period.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BTDS 5, 10 or 20
Buprenorphine transdermal patch
Drug: Buprenorphine transdermal patch
Buprenorphine transdermal patch 5, 10 or 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
Number of Participants With Adverse Events (AEs) as a Measure of Safety.
Time Frame: 28 weeks
Safety was assessed using reports of all new adverse events (AEs) that occurred after the first application of a patch during the extension phase were recorded.
28 weeks

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, 2001

Primary Completion (Actual)

February 1, 2002

Study Completion (Actual)

February 1, 2002

Study Registration Dates

First Submitted

June 24, 2010

First Submitted That Met QC Criteria

June 24, 2010

First Posted (Estimate)

June 25, 2010

Study Record Updates

Last Update Posted (Estimate)

September 10, 2012

Last Update Submitted That Met QC Criteria

September 5, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BUP3201S

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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