Buprenorphine Transdermal System (BTDS) in Subjects w/Mod-sev Osteoarthritis (OA) Chronic Pain of Knee

September 5, 2012 updated by: Purdue Pharma LP

Randomized, Double-blind, Placebo-controlled With Open-label Run-in Assessing Efficacy, Tolerability,Safety of BTDS 10 or 20 Compared to Placebo in Opioid-naïve Subjects w/Moderate to Severe, Chronic Pain Due to OA of Knee

The objective of this study is to determine the analgesic efficacy and safety of Buprenorphine Transdermal System (BTDS) 10 and 20 compared to placebo in opioid-naïve subjects with moderate to severe chronic pain due to osteoarthritis (OA) of the knee. The double-blind treatment intervention duration is 12 weeks, during which time supplemental analgesic medication (immediate-release oxycodone for the first 6 days postrandomization and acetaminophen or ibuprofen for the remainder of the double-blind phase) 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 settings for the relief of moderate to severe pain. BTDS is a transdermal system formulation that is designed to deliver a consistent and a steady dose of buprenorphine over a 7-day period with limited blood concentration fluctuation.

Study Type

Interventional

Enrollment (Actual)

567

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
      • Mobile, Alabama, United States, 36608
        • Coastal Clinical Research, Inc.
    • Arizona
      • Chandler, Arizona, United States, 85225
        • Radiant Research, Phoenix Southeast
      • Phoenix, Arizona, United States, 85023
        • Arizona Research Center, Inc.
      • Phoenix, Arizona, United States, 85029
        • Research Facility
      • Phoenix, Arizona, United States, 85032
        • Research Facility
    • California
      • Anaheim, California, United States, 92801
        • Research Facility
      • Beverly Hills, California, United States, 90211
        • Lovelace Scientific Resources, Inc.
      • Chino, California, United States, 91710
        • Catalina Research Institute
      • Downey, California, United States, 90241
        • Research Facility
      • Foothill Ranch, California, United States, 92610
        • Research Facility
      • Laguna Hills, California, United States, 92653
        • Research Facility
      • Sacramento, California, United States, 95831
        • Research Facility
    • Colorado
      • Littleton, Colorado, United States, 80128
        • Research Facility
    • Connecticut
      • Stamford, Connecticut, United States, 06905
        • Research Facility
    • Florida
      • Bradenton, Florida, United States, 34209
        • Coastal Pain Management
      • Clearwater, Florida, United States, 33765
        • Clinical Research of West Florida
      • Clearwater, Florida, United States, 33765
        • Research Facility
      • Jupiter, Florida, United States, 33458-7200
        • Research Facility
      • Largo, Florida, United States, 33765
        • Research Facility
      • Miami, Florida, United States, 33126
        • Pharmax Research Clinic
      • Miami, Florida, United States, 33135
        • Research Facility
      • Orlando, Florida, United States, 32806
        • Research Facility
      • Plantation, Florida, United States, 33324
        • Research Facility
      • Royal Palm, Florida, United States, 33411
        • Research Facility
      • Tampa, Florida, United States, 33603
        • Clinical Research of West Flor
      • Tampa, Florida, United States, 33613
        • Research Facility
      • Venice, Florida, United States, 34292
        • Research Facility
      • West Palm Beach, Florida, United States, 33409
        • Research Facility
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Research Facility
      • Augusta, Georgia, United States, 30901
        • Research Facility
      • Bogart, Georgia, United States, 30622-6821
        • AMR Research Associates
      • Dawsonville, Georgia, United States, 30534
        • Research Facility
      • Decatur, Georgia, United States, 30033
        • Research Facility
      • Marietta, Georgia, United States, 30066
        • Research Facility
    • Hawaii
      • Honolulu, Hawaii, United States, 96814-4526
        • Research Facility
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Rehabilitation Association of IN
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Research Facility
    • Kentucky
      • Bowling Green, Kentucky, United States, 42101
        • Graves-Gilbert Clinic
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Stat-Lab I, Inc.
      • New Iberia, Louisiana, United States, 70563
        • Research Facility
      • New Orleans, Louisiana, United States, 70114
        • Research Facility
    • Maryland
      • Frederick, Maryland, United States, 21702
        • Research Facility
    • Massachusetts
      • Brockton, Massachusetts, United States, 02301
        • Research Facility
      • Haverhill, Massachusetts, United States, 01830-6141
        • East Coast Clinical Research
      • Springfield, Massachusetts, United States, 01103
        • Research Facility
    • Michigan
      • Bay City, Michigan, United States, 48706
        • Research Facility
    • Mississippi
      • Biloxi, Mississippi, United States, 39531
        • Premier Internal Medicine
    • Missouri
      • Florissant, Missouri, United States, 63031
        • Research Facility
      • St. Louis, Missouri, United States, 63117
        • Research Facility
      • St. Louis, Missouri, United States, 63141
        • Sports Med Consultants PC
    • Nevada
      • Henderson, Nevada, United States, 89014
        • Research Facility
    • New York
      • New York, New York, United States, 10004
        • Research Facility
      • New York, New York, United States, 10022
        • Research Facility
    • North Carolina
      • Morgantown, North Carolina, United States, 28655
        • Research Facility
      • Winston-Salem, North Carolina, United States, 27103
        • Research Facility
    • Ohio
      • Canton, Ohio, United States, 44718
        • Research Facility
      • Cincinnati, Ohio, United States, 45242
        • Research Facility
      • Columbus, Ohio, United States, 43213
        • Research Facility
      • Columbus, Ohio, United States, 43235
        • Research Facility
      • Dayton, Ohio, United States, 45415
        • Digestive Endoscopy Center
      • Dayton, Ohio, United States, 45432
        • Research Facility
      • Middleburg Heights, Ohio, United States, 44130
        • Research Facility
      • Mt. Gilead, Ohio, United States, 43338
        • Research Facility
      • Toledo, Ohio, United States, 43623
        • Research Facility
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73109
        • Research Facility
    • Oregon
      • Eugene, Oregon, United States, 97404
        • Research Facility
      • Medford, Oregon, United States, 97504-8311
        • Research Facility
    • Pennsylvania
      • Bridgeville, Pennsylvania, United States, 15017
        • Paramount Clinical Research
      • Duncansville, Pennsylvania, United States, 16635
        • Research Facility
      • Lancaster, Pennsylvania, United States, 17601
        • Oyster Point Family Health Ctr
      • Mechanicsburg, Pennsylvania, United States, 17055
        • Research Facility
      • West Reading, Pennsylvania, United States, 19611
        • Research Facility
    • Rhode Island
      • Cranston, Rhode Island, United States, 02920
        • New England Center for Clinical Research
      • Cranston, Rhode Island, United States, 02920
        • Research Facility
    • South Carolina
      • Greenville, South Carolina, United States, 29415
        • Greenville Pharmaceutical Research
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • Arthritis Clinic, PLLC
    • Texas
      • Austin, Texas, United States, 78756
        • Research Facility
      • Colleyville, Texas, United States, 76034
        • Research Facility
      • Dallas, Texas, United States, 75230
        • Research Facility
      • Nederland, Texas, United States, 77627
        • Research Facility
      • San Antonio, Texas, United States, 78205-1116
        • Research Facility
      • San Antonio, Texas, United States, 78229
        • Research Facility
      • Sugarland, Texas, United States, 77479
        • Research Facility
    • Utah
      • Salt Lake City, Utah, United States, 84102
        • Research Facility
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • NDC Medical Center
      • Virginia Beach, Virginia, United States, 23455
        • Independence Family Medicine
    • Washington
      • Tacoma, Washington, United States, 98405
        • Pacific Northwest Primary Care

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:

  • subjects with moderate to severe chronic osteoarthritis (OA) pain of the knee (lasting several hours daily) as their predominant pain condition,
  • clinical diagnosis of OA of the knee 1 year or longer,
  • subjects treated within the 14 days prior to screening with nonopioid therapy only, or with therapy including opioids at a dose of < 5 mg oxycodone (or equivalent) per day,
  • subjects whose OA knee pain is not adequately controlled with nonopioid analgesic medication and who the investigator feels are appropriate candidates for around-the-clock opioid therapy.

Exclusion Criteria:

  • subjects who have had arthroscopy on either knee or hip within 6 months of entering the study or open surgery on either knee or hip within 9 months of entering the study,
  • subjects who are allergic to buprenorphine or who have a history of allergies to other opioids,
  • subjects who have allergies or other contraindications to transdermal delivery systems or patch adhesives.

Other protocol-specific inclusion/exclusion 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: 1
Buprenorphine transdermal system 10 and 20 applied for 7-day wear
Drug: Buprenorphine
transdermal system 10 and 20 applied for 7-day wear
Placebo Comparator: 2
Placebo transdermal system to match BTDS patches, applied for 7-day wear
Drug: Placebo
transdermal system (placebo) applied for 7-day wear

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
"Average Pain Over the Last 24 Hours" Score of the Study Knee at Week 12 of the Double Blind Phase.
Time Frame: 24 hours (week 12)
"Average pain over the last 24 hours" scores of the study knee at week 12 was evaluated on an 11-point scale: 0 = no pain, 10 = worst pain imaginable, recorded daily.
24 hours (week 12)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Daily Number of Tablets of Nonopioid Supplemental Analgesic Used From Week 2 to 12 of the Double-blind Phase.
Time Frame: 10 weeks
Subjects were permitted to take sponsor-provided supplemental analgesic medication after week 1 of the double-blind treatment (acetaminophen or ibuprofen).
10 weeks
Sleep Disturbance Subscale of the MOS-Sleep Scale at Weeks 4, 8, and 12 of the Double-blind Phase.
Time Frame: Weeks 4, 8, and 12 of the double-bind phase
The MOS Sleep Scale consists of 12 individual items (4 sleep disturbance, 2 sleep adequacy, 1 quantity of sleep and optimal sleep, 3 somnolence, 1 snoring, and 1 shortness of breath) and takes 5 to 10 minutes to complete. Question 1 is scored on a scale of 1 to 5 ( 1 = 0-15 min to more than 60 min) and Questions 2 to 12 are scored on a scale of 1 to 6 (1 = all of the time to 6 = none of the time. The Sleep Disturbance Subscale score is derived from the scores to Questions 1, 3, 7, and 8 and ranges from 0 to 100, where higher scores indicate greater sleep disturbance.
Weeks 4, 8, and 12 of the double-bind 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

September 1, 2007

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

September 17, 2007

First Submitted That Met QC Criteria

September 17, 2007

First Posted (Estimate)

September 18, 2007

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

  • BUP3025

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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