The Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Chronic Back Pain.

May 1, 2006 updated by: Purdue Pharma LP

A Double-Blind Comparative Study of Buprenorphine Transdermal System (BTDS) and Hydrocodone/Acetaminophen Tablets in Patients With Chronic Back Pain

The objective of this study is to assess the safety and efficacy of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system and hydrocodone/acetaminophen in subjects with chronic back pain. The double-blind treatment intervention duration is 56 days during which time supplemental analgesic medication (ibuprofen) 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 twenty-five 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

250

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
      • Huntsville, Alabama, United States, 35801
        • Rheumatology Associates of North Alabama
    • Arizona
      • Phoenix, Arizona, United States, 85023
        • Arizona Research Center
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
        • Arthritis Center of Connecticut
    • Florida
      • Deland, Florida, United States, 32720
        • University Clinical Research
      • Gainesville, Florida, United States, 32605
        • Gainesville Clinical Research Center
      • Miami, Florida, United States, 33173
        • Miami Research Associates
      • Sarasota, Florida, United States, 34239
        • Sarasota Arthritis Center
      • South Daytona Beach, Florida, United States, 32119
        • Coastal Medical Research
      • West Palm Beach, Florida, United States, 33409
        • Palm Beach Research Center
      • Weston, Florida, United States, 33331
        • Private Practice
    • Indiana
      • Terre Haute, Indiana, United States, 47807
        • Pain Management & Rehabilitation
    • Kansas
      • Overland Park, Kansas, United States, 66209
        • Mid-America Rheumatology Consultants
    • Kentucky
      • Crestview Hills, Kentucky, United States, 41017
        • Riverhills Healthcare
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Arthritis & Osteoporosis Treatment & Research Center
    • Missouri
      • Kansas City, Missouri, United States, 64114
        • Center for Pharmaceutical Research
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • PrecisionMed, Inc.
    • North Carolina
      • High Point, North Carolina, United States, 27262
        • Cornerstone Research Care
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Consultants for Clinical Research
    • Texas
      • Austin, Texas, United States, 78758
        • Center for Clinical Research
    • Virginia
      • Arlington, Virginia, United States, 22206
        • The Arthritis Clinic of Northern Virginia
    • Washington
      • Edmonds, Washington, United States, 98026
        • Evergreen Clinical Research
    • Wisconsin
      • Wauwatosa, Wisconsin, United States, 53226
        • Private Practice

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:

  • clinical evidence of chronic back pain related to intervertebral disc disease, nerve root entrapment, spondylolithesis, osteoarthritis, or other, similar nonmalignant conditions.
  • back pain treated with an opioid-containing analgesic at a dose equal to or less than the equivalent of 90 mg of oral morphine per day or 12 or fewer capsules or tablets of an opioid combination analgesic per day.

Exclusion Criteria:

  • receiving opioids at an average daily dose of greater than 90 mg of oral morphine equivalents or patients receiving more than 12 tablets per day of short-acting opioid-containing products.
  • scheduled to have surgery (including dental) during the study period that involved the use of pre- and/or postoperative analgesics or anesthetics.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Patient Satisfaction With Medication for Pain and Average Pain Intensity scores on days 0, 7, 14, 21, 28, 35, 42, 49, 56 and, if applicable, at early termination.

Secondary Outcome Measures

Outcome Measure
Average Pain Intensity and Patient Satisfaction With Medication for Pain scores (Patient Global Efficacy Rating)
incidence of and time to early discontinuation due to lack of efficacy
investigator's assessment of therapeutic response
dose level at the end of titration

Collaborators and Investigators

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

Sponsor

Purdue Pharma LP

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, 1999

Study Completion

October 1, 1999

Study Registration Dates

First Submitted

April 18, 2006

First Submitted That Met QC Criteria

April 18, 2006

First Posted (Estimate)

April 19, 2006

Study Record Updates

Last Update Posted (Estimate)

May 3, 2006

Last Update Submitted That Met QC Criteria

May 1, 2006

Last Verified

April 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BP98-1201

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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