Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Low Back Pain

August 27, 2012 updated by: Purdue Pharma LP

A Multicenter, Randomized, Double-blind, Active Comparator Study to Determine the Efficacy and Safety of BTDS 20 or Oxycodone Immediate-release Versus BTDS 5 in Subjects With Moderate to Severe Low Back Pain

The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) 20 in comparison to the buprenorphine transdermal system (BTDS) 5 and oxycodone immediate-release in subjects with moderate to severe low back pain currently treated with oral opioids. The double-blind treatment intervention duration is 12 weeks during which time supplemental analgesic medication (acetaminophen, ibuprofen) will be provided to all subjects in addition to study drug.

Study Overview

Status

Terminated

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)

660

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
      • Birmingham, Alabama, United States, 35244
        • Birmingham Pain Center
      • Birmingham, Alabama, United States, 35249
        • Arthritis Clinical Intervention Program
      • Haleyville, Alabama, United States, 35565
        • Winston Physician Services, LLC
    • Arizona
      • Phoenix, Arizona, United States, 85023
        • Arizona Research Center, Inc.
      • Phoenix, Arizona, United States, 85029
        • Radiant Research
      • Tuscon, Arizona, United States, 85712
        • Advanced Clinical Therapeutics
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Hot Springs Pain Clinic
    • California
      • Anaheim, California, United States, 92805
        • NuLife Clinical Research, Inc.
      • Beverly Hills, California, United States, 90211
        • Lovelace Scientific Resources, Inc.
      • Carmichael, California, United States, 95608
        • Northern California Research Corp
      • Chula Vista, California, United States, 91911
        • International Clinical Research Network
      • Fountain Valley, California, United States, 92708
        • Shreenath Clinical Service
      • Sacramento, California, United States, 95817
        • U of Calif at Davis, Med Ctr, Pain Management Center
      • San Diego, California, United States, 92108
        • Accelovance
    • Colorado
      • Pueblo, Colorado, United States, 81008
        • Southern Colorado Clinic
    • Florida
      • Chiefland, Florida, United States, 32626
        • Chiefland Medical Center
      • Deland, Florida, United States, 32720
        • University Clinical Research, Inc.
      • Jupiter, Florida, United States, 33458
        • Drug Study Institute
      • Largo, Florida, United States, 33770
        • Innovative Research of West Florida, Inc.
      • Ocala, Florida, United States, 34471
        • Renstar Medical
      • Ormond Beach, Florida, United States, 32174
        • Peninsula Research Inc.
      • Palm Harbor, Florida, United States, 34684
        • The Arthritis Center
      • Pembroke Pines, Florida, United States, 33024
        • University Clinical Research, Inc.
      • Plantation, Florida, United States, 33324
        • Gold Coast Research, LLC
      • Port Orange, Florida, United States, 32168
        • Coastal Medical Research
      • West Palm Beach, Florida, United States, 33409
        • Palm Beach Research Center
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Georgia Medical Research Institute
      • Stockbridge, Georgia, United States, 30281
        • Atlanta Knee & Shoulder Clinic
    • Idaho
      • Boise, Idaho, United States, 83702
        • Pain Care Boise
      • Meridian, Idaho, United States, 83742
        • Idaho Arthritis and Osteoporosis Center
    • Illinois
      • Chicago, Illinois, United States, 60610
        • Pain and Rehabilitation Clinic of Chicago
    • Indiana
      • Evansville, Indiana, United States, 47714
        • MediSphere Medical Research Center, LLC
      • Evansville, Indiana, United States, 47714
        • GFI Research Center
    • Iowa
      • Dubuque, Iowa, United States, 52002
        • Medical Associates Clinics
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Vince and Associates Clinical Research
      • Prairie Village, Kansas, United States, 66206
        • Ctt, Inc.
    • Kentucky
      • Madisonville, Kentucky, United States, 42431
        • Commonwealth Biomedical Research, LLC
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • New Orleans Clinical Trial Management Inc.
      • New Orleans, Louisiana, United States, 70114
        • Louisiana Research Associates, Inc.
      • New Orleans, Louisiana, United States, 70115
        • Best Clinical Trials, LLC
      • New Orleans, Louisiana, United States, 70115
        • Research Center of Louisiana
    • Maryland
      • Baltimore, Maryland, United States, 21215
        • Sinai Hospital of Baltimore
    • Massachusetts
      • Springfield, Massachusetts, United States, 11070
        • Future Care Studies
    • Michigan
      • Kalamazoo, Michigan, United States, 49009
        • Rheumatology Pc
      • Saint Joseph, Michigan, United States, 49085
        • Lake Michigan Clinical Research & Consulting, Inc.
    • Missouri
      • St Louis, Missouri, United States, 63141
        • HealthCare Research
      • St Louis, Missouri, United States, 63108
        • Medex Healthcare Research, Inc.
    • Nebraska
      • Omaha, Nebraska, United States, 68134
        • Meridian Clinical Research, LLC
    • Nevada
      • Henderson, Nevada, United States, 89014
        • Lovelace Scientific Resources
      • North Las Vegas, Nevada, United States, 89030
        • Pivotal Research Centers
    • New York
      • New York, New York, United States, 10022
        • Research Across America
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Pain and Orthopedic Neurology , Charlotte Spine Center,
      • Charlotte, North Carolina, United States, 28209
        • Metrolina Medical Research
      • Durham, North Carolina, United States, 27704
        • Triangle Orthopaedic Associates
      • Greensboro, North Carolina, United States, 27401
        • PharmQuest
      • Morgantown, North Carolina, United States, 28655
        • Medark Clinical Research
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates, LLC
      • Winston Salem, North Carolina, United States, 27103
        • Center for Clinical Research
    • North Dakota
      • Bismark, North Dakota, United States, 58502
        • Odyssey Research
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • COR Clinical Research, LLC
      • Oklahoma City, Oklahoma, United States, 73112
        • Associated Medical Services
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
        • Keystone Clinical Research
      • Bethlehem, Pennsylvania, United States, 18016
        • Valley Pain Specialists
      • Duncansville, Pennsylvania, United States, 16635
        • Altoona Center For Clinical Research
      • Mechanicsburg, Pennsylvania, United States, 17055
        • Central Pennsylvania Clinical Research
      • Shippensburg, Pennsylvania, United States, 17257
        • BioMedical Research Associates
      • State College, Pennsylvania, United States, 16801
        • University Orthopedics Center
    • Rhode Island
      • Cranston, Rhode Island, United States, 29200
        • New England Center Clinical Research
      • Warwick, Rhode Island, United States, 28860
        • Omega Medical Research
    • South Carolina
      • Orangeburg, South Carolina, United States, 29118
        • Arthritis & Osteoporosis Center
    • South Dakota
      • Watertown, South Dakota, United States, 57201
        • Brown Clinic
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • Holston Medical Group
      • Bristol, Tennessee, United States, 37620
        • Tri Cities Medical Research
      • Kingsport, Tennessee, United States, 37660
        • Holston Medical Group
    • Texas
      • Dallas, Texas, United States, 75251
        • Galenos Research
      • Fort Worth, Texas, United States, 76135
        • Benchmark Research
      • Harker Heights, Texas, United States, 76548
        • Team Research of Central Texas
      • Richardson, Texas, United States, 75080
        • KRK Medical Research
      • San Angelo, Texas, United States, 76904
        • Benchmark Research
      • San Antonio, Texas, United States, 78233
        • Unlimited Research
      • San Antonio, Texas, United States, 78238
        • Texas Medical Research Associates
      • Spring, Texas, United States, 77386
        • Clinical Trial Network Oaks Medical Center
      • Wichita Falls, Texas, United States, 76301
        • N. Texas Neuro Research
    • Utah
      • Salt Lake City, Utah, United States, 84106
        • Lifetree Clinical Research
    • Wisconsin
      • Oregon, Wisconsin, United States, 53575
        • Dean Medical Center

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:

  • low back pain for 3 months or longer, confirmed by radiographic evidence.
  • receiving a stable dose of an opioid analgesic for low back pain.

Exclusion Criteria:

  • taking more than 80 mg per day of oral morphine sulfate or equivalent within 30 days of enrollment.
  • requiring frequent analgesic therapy for chronic condition(s), in addition to low back 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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: BTDS 5
Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear.
Drug: Buprenorphine
Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear.
Other Names:
  • Butrans™
Drug: Buprenorphine
Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
Other Names:
  • Butrans™
Experimental: BTDS 20
Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear.
Drug: Buprenorphine
Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear.
Other Names:
  • Butrans™
Drug: Buprenorphine
Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
Other Names:
  • Butrans™
Experimental: Oxycodone Immediate-Release
Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).
Drug: Oxycodone Immediate-Release
Oxycodone HCl immediate-release 40 mg (two 5-mg capsules every 6 hours).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Pain Over the Last 24 Hours Score at Weeks 4, 8, and 12.
Time Frame: Last 24 hours score at weeks 4, 8, 12 of the double-blind phase
Subjects were evaluated during the double-blind phase for "average pain over the last 24 hours" prior to the study visits. Pain scale is 11 points (0 = no pain to 10 = pain as bad as you can imagine)
Last 24 hours score at weeks 4, 8, 12 of the double-blind phase

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Daily Number of Supplemental Analgesic Tablets
Time Frame: Double-blind phase (84 days)
The mean daily number of tablets of supplemental analgesic medications used during the double-blind phase
Double-blind phase (84 days)
Oswestry Disability Index (ODI) Score (V 2.0)
Time Frame: Weeks 4, 8, 12

The ODI (version 2) is a low back pain-specific, validated instrument that consists of questions related to limitations in performing specific activities of daily living and 1 question related to pain intensity. The ODI is a self-administered questionnaire that is usually completed in less than 5 minutes.

The ODI consists of 10 sections. Each section consists of 6 statements ranked from 0 to 5 (0 = good to 5 = worse). (Note: A higher score represents greater disability.)
Weeks 4, 8, 12
The Sleep Disturbance Subscale in the MOS-Sleep Scale at Weeks 4, 8, and 12.
Time Frame: Weeks 4, 8, 12 of the double-blind phase

The MOS-Sleep Scale consists of 12 individual items: (4 sleep disturbance, 2 sleep adequacy, 1 quantity/ optimal sleep, 3 somnolence, 1 snoring, and 1 shortness of breath).

Question 1 is scored on a scale of 1 to 5 and Questions 3 to 12 are scored on a scale of 1 to 6. 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, 12 of the double-blind phase

Collaborators and Investigators

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

Sponsor

Purdue Pharma LP

Investigators

  • Principal Investigator: Martin Hale, MD, Gold Coast Research LLC, Weston, FL, USA

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.

General Publications

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

February 1, 2004

Primary Completion (Actual)

September 1, 2005

Study Completion (Actual)

September 1, 2005

Study Registration Dates

First Submitted

April 10, 2006

First Submitted That Met QC Criteria

April 10, 2006

First Posted (Estimate)

April 11, 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

  • BUP3015

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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