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

May 13, 2013 updated by: Purdue Pharma LP

Safety and Efficacy of Buprenorphine TDS (Transdermal Delivery System) 5, 10 and 20 Applied Every 7 Days for Sixty Days vs. 5 mg Oxycodone/325 mg Acetaminophen Tablets q6h Prn vs. Placebo in Patients With Chronic Low Back Pain

The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system and immediate release oxycodone/acetaminophen in subjects with chronic low back pain inadequately treated with non-opioid analgesics. The double-blind treatment intervention duration is 60 days.

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

225

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, 85012
        • Arizona Research & Education
      • Phoenix, Arizona, United States, 85008
        • Hawthorne & York, Intl, Ltd
    • Florida
      • Gainesville, Florida, United States, 32605
        • Gainesville Clinical Research Center
      • Plantation, Florida, United States, 33324
        • Park Place Therapeutic Center
    • Georgia
      • Atlanta, Georgia, United States, 30033
        • Atlanta Research Center
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Rheumatology Associates, Inc.
    • Michigan
      • Kalamazoo, Michigan, United States, 49009
        • Westside Family Medical Center
    • Missouri
      • Kansas City, Missouri, United States, 64114
        • The Center for Pharmaceutical Research
    • New York
      • New York, New York, United States, 10021
        • The New York Hospital Cornell Medical Center
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • NC Clinical Research, Inc.
      • Winston-Salem, North Carolina, United States, 27103
        • Pain Control Ctr Bowman Gray School of Med
    • Texas
      • Dallas, Texas, United States, 75235
        • Metroplex Clinical Research 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:

  • unacceptable pain control despite currently taking a nonsteroidal anti-inflammatory drug considered at a therapeutic and/or tolerated dose or currently taking </=2 short-acting opioid doses per day.
  • taking >/=3 opioid doses per day with or without acceptable pain control.

Exclusion Criteria:

  • receiving opioids at an average daily dose of greater than 60 mg of oral morphine equivalents or subjects receiving more than 6 tablets per day of a short-acting opioid.
  • scheduled to have surgery (including dental) involving the use of post- or preoperative analgesics or anesthetics during 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
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Pain on average and pain right now scores at days 0, 9, 15, 30, 45, 60, or if applicable, at early termination.

Secondary Outcome Measures

Outcome Measure
Brief Pain Inventory
dropouts due to lack of efficacy
MOS health survey
VAS pain intensity
therapeutic response
patient preference
daily patient diary
and number of oxycodone/acetaminophen or placebo tablets taken

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, 1997

Study Completion

January 1, 1998

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 14, 2013

Last Update Submitted That Met QC Criteria

May 13, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BP96-0102

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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