Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Nonmalignant Pain

September 5, 2012 updated by: Purdue Pharma LP

An Open-label Run-in, Followed by a Randomized, Double-blind, Placebo Controlled, Parallel Group Study to Show the Effectiveness of Buprenorphine Transdermal System in Management of Patients With Chronic Nonmalignant Pain Syndromes

The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (5, 10 and 20) in comparison to matching placebo transdermal system in subjects with chronic nonmalignant pain syndromes currently controlled by oral opioids. The double-blind treatment intervention duration is 2 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)

267

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 Kingdom
      • Glasgow, United Kingdom, G31 2ES
        • Townhead Health Centre
      • Glasgow, United Kingdom, G45 9AW
        • Castlemilk Health Centre
    • Belfast
      • Newtownabbey, Belfast, United Kingdom, BT37 9QN
        • Whiteabbey Health Centre
    • CO Antrim
      • Portglenone, CO Antrim, United Kingdom, BT44 8AD
        • Portglenone Health Centre
    • Co Antrim
      • Lame, Co Antrim, United Kingdom, BT40 1XH
        • Antrim Coast Fundholding Group
    • Co Derry
      • Magherafelt, Co Derry, United Kingdom, BT45 5DD
        • Garden Street Surgery
    • Co Down
      • Bangor, Co Down, United Kingdom, BT19 1PP
        • Springhill Surgery
    • Coventry
      • Keresley End, Coventry, United Kingdom, CV7 8LA
        • Bennett Road Surgery
    • E Sussex
      • Bexhill-on-Sea, E Sussex, United Kingdom, TN39 4SP
        • Little Common Surgery
      • Bexhill-on-Sea, E Sussex, United Kingdom, TN40 2HG
        • Old Town Surgery
      • Hastings, E Sussex, United Kingdom, TN34 3EY
        • Roebuck House Surgery
    • Fife
      • Glenrothes, Fife, United Kingdom, KY6 3LQ
        • Leslie Surgery
      • High Valleyfield, Fife, United Kingdom, KY12 8SJ
        • Valleyfield Health Centre
    • Hants
      • Aldershot, Hants, United Kingdom, GU12 5BA
        • Ashvale Health Centre
    • Lanarkshire
      • Coatbridge, Lanarkshire, United Kingdom, L5 3AP
        • The Academy Medical Practice
    • Middx
      • Sunbury-on-Thames, Middx, United Kingdom, TW16 6RH
        • Sanbury Health Centre Group Practice
    • Renfrewshire
      • Houston, Renfrewshire, United Kingdom, PA6 7AR
        • Houston Surgery
    • S Yorkshire
      • Doncaster, S Yorkshire, United Kingdom, DN1 2EG
        • The Burns Practice
    • W Sussex
      • Tunbridge Wells, W Sussex, United Kingdom, TN1 2EP
        • Grosvenor Medical Centre
    • Warwickshire
      • Coventry, Warwickshire, United Kingdom, CV6 4DD
        • Gables Medical Section
    • West Yorkshire
      • Bradford, West Yorkshire, United Kingdom, BD7 3EE
        • The Ridge Medical Practice, Great Horton
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85023
        • Arizona Research Center Inc
      • Phoenix, Arizona, United States, 85008
        • Hawthorne and York
    • 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, 32702
        • 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, 47802
        • Pain Management and 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
    • Ohio
      • Chardon, Ohio, United States, 44024
        • Private Practice
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Summit Research Solutions
    • Texas
      • Austin, Texas, United States, 78758
        • Radiant Research
    • 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:

  • At least 2 month's history of nonmalignant pain, currently in stable pain control on opioid therapy.
  • Good, very good or excellent pain control on current opioid therapy.
  • Willing and able to use a telephone interactive voice response service.

Exclusion Criteria:

  • Currently receiving daily morphine or oxycodone monotherapy.
  • Scheduled for surgery of the disease site (eg, major joint replacement surgery), or any other major surgery, which 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 (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™
Placebo Comparator: Placebo to match BTDS
Placebo to match buprenorphine transdermal patch
Drug: Placebo to match BTDS
Placebo to match buprenorphine transdermal patch applied for 7-day wear.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Number of Subjects With Ineffective Treatment During the Double-blind Evaluation Phase.
Time Frame: Double-blind phase (14 days)

Ineffective treatment was defined as:

  • Subject took >1 gram of acetaminophen in a 24-hour period, or
  • Subject required a change in transdermal patch (TDS) dose, or
  • Subject had difficulty in keeping the TDS on, or
  • Subject discontinued due to ineffective treatment (but did not meet any of the above criteria).

Note: some subjects may have had multiple reasons for ineffective treatment and are counted under each category. Therefore the sum of subjects across all criteria for ineffective treatment is greater than the total number of subjects with ineffective treatment.
Double-blind phase (14 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time (Days) From the Initial Dose of Study Drug in the Double-blind Evaluation Phase to Ineffective Treatment
Time Frame: 14 days

The time of ineffective treatment was calculated as the earliest of the following:

  • The date the subject first took >1 gram of acetaminophen,
  • The visit date when ineffective treatment was first determined, or
  • The date the last patch was removed.
14 days
The Number of Subjects Who Had Ineffective Treatment or Who Discontinued Due to Reasons Other Than Ineffective Treatment in the Double-blind Phase
Time Frame: 14 days
Note: The total numbers of "Subjects w/ineffective treatment or who discont'd" for placebo and BTDS are 1 less because there were reasons other than lack of efficacy that made up this total: adverse event, death, lost to follow- up, protocol violation, and other. Example for placebo 89+5=94; however, 93 is indicated for the total because there is 1 subject in the placebo group who was counted under ineffective treatment and discontinued due to reasons other than lack of efficacy. The same is true for 1 subject in BTDS.
14 days
The Amount of Rescue Medication Used for Pain (Average Daily Number of Acetaminophen Tablets).
Time Frame: 14 days
The average daily acetaminophen (Panadol) use (1 tablet = 500 mg) during the double-blind phase was compared between the treatment groups using ANCOVA methodology with terms for country and treatment. The average escape medication used in the last 4 days prior to randomization was included as a covariate.
14 days

Collaborators and Investigators

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

Sponsor

Purdue Pharma LP

Collaborators

Napp Pharmaceuticals Limited

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

March 1, 2001

Primary Completion (Actual)

July 1, 2001

Study Completion (Actual)

July 1, 2001

Study Registration Dates

First Submitted

April 5, 2006

First Submitted That Met QC Criteria

April 6, 2006

First Posted (Estimate)

April 7, 2006

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

  • BUP3201

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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