Buprenorphine Transdermal Patch in Subjects With Osteoarthritis Pain Requiring Opioids. Includes a 52-Week Safety Extension.

August 27, 2012 updated by: Purdue Pharma LP

Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study to Determine Efficacy and Safety of Buprenorphine Transdermal System in Subjects With Moderate To Severe Osteoarthritis Pain Requiring Daily Treatment With Opioids

The original objective of this study was to assess the safety and efficacy of the buprenorphine transdermal system (BTDS) (5, 10, and 20) in comparison to placebo transdermal system in subjects with moderate to severe osteoarthritis pain. However, this study was terminated early with only 35% of the planned sample size, therefore the primary objective is changed to focus on the safety evaluations.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
107

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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, 35215
        • Parkway Medical Center
      • Birmingham, Alabama, United States, 35244
        • Clinical Research Consultants
      • Haleyville, Alabama, United States, 35565
        • Winston Physician Services, Inc
      • Muscle Shoals, Alabama, United States, 35661
        • Private practice
      • Tuscaloosa, Alabama, United States, 35406
        • Clinic for Rheumatic Diseases
    • Arizona
      • Phoenix, Arizona, United States, 85023
        • Arizona Research Center
      • Phoenix, Arizona, United States, 85013
        • Radiant Research
      • Tuscon, Arizona, United States, 85715
        • ACRC/Arizona Clinical Research
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences
    • California
      • Buena Park, California, United States, 90620
        • Southbay Pharma Research
      • Torrance, California, United States, 90505
        • Torrence Clinical Research
    • Florida
      • Boynton Beach, Florida, United States, 33437
        • Comprehensive Neuroscience Inc
      • Chiefland, Florida, United States, 32626
        • Chiefland Medical Center
      • Deland, Florida, United States, 32720
        • University Clinical Research Deland
      • Gainesville, Florida, United States, 32605
        • Florida Medical Research Institute
      • Jupiter, Florida, United States, 33458
        • Drug Study Institute
      • Orange City, Florida, United States, 32763
        • Coastal Medical Research
      • Ormond Beach,, Florida, United States, 32174
        • Ormond Medical Arts Pharmaceutical Res Ctr
      • Palm Harbor, Florida, United States, 34684
        • The Arthritis Center
      • Pembroke Pines, Florida, United States, 33024
        • Avancia Research
      • Port Orange, Florida, United States, 32127
        • Coastal Medical Research
      • West Palm Beach, Florida, United States, 33409
        • Palm Beach Research Center
      • Weston, Florida, United States, 33321
        • Gold Coast Research LLC
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Georgia Medical Research Institute
    • Illinois
      • Gurnee, Illinois, United States, 60031
        • Internal Medicine Northwest
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Medisphere Medical Research Center
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville Medical/Rheumatology
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Clinical Trials Management, LLC
    • Massachusetts
      • Springfield, Massachusetts, United States, 01107
        • Future Care Studies
    • Michigan
      • Bay City, Michigan, United States, 48706
        • Bay Area Health Clinic
    • Missouri
      • St Louis, Missouri, United States, 63108
        • Medex Healthcare Research Inc
    • New York
      • New York, New York, United States, 10003
        • Beth Israel Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73109
        • Health Research Institute
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
        • Keystone Clinical Solutions
      • Duncansville, Pennsylvania, United States, 16635
        • Altoona Center for Clinical Research
      • Shippensburg, Pennsylvania, United States, 17257
        • BioMedical Research Associates
      • State College, Pennsylvania, United States, 16801
        • University Orthopedics Center
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • Omega Medical Research
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Low Country Rheumatology
    • South Dakota
      • Watertown, South Dakota, United States, 57201
        • Brown Clinic
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • Holston Medical Group
      • Memphis, Tennessee, United States, 38119
        • CSS Research
      • Selmer, Tennessee, United States, 38375
        • Prime Care Medical Center
    • Texas
      • Harker Heights, Texas, United States, 76548
        • Team Research of Central Texas
      • San Antonio, Texas, United States, 78209
        • Quality Research
    • Virginia
      • Virginia Beach, Virginia, United States, 23462
        • Sentara Medical Group
      • Virginia Beach, Virginia, United States, 23454
        • Advanced Pain Management and Rehab Hilltop Med Center
    • Washington
      • Spokane, Washington, United States, 99204
        • Physicians Clinic Of Spokane

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • clinical evidence of osteoarthritis of the hip, knee, or spine joint for ≥ 1 year currently adequately treated with short acting opioids.
  • taking ≥ 30 and ≤ 80 mg oral morphine or morphine equivalents per day for ≥ 2 weeks for control of their osteoarthritis pain.

Exclusion Criteria:

  • requiring frequent analgesic therapy for chronic condition(s), other than osteoarthritis of the hip, knee, or spine.
  • scheduled for surgery of the disease site (e.g., major joint replacement surgery), or any other major surgery that 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: BTDS
Buprenorphine transdermal patches 10 or 20 mcg/h
Drug: Buprenorphine transdermal patch
Buprenorphine transdermal patch applied for 7-day wear.
Other Names:
  • Butrans™
Placebo Comparator: Placebo
Placebo to match buprenorphine transdermal patch 10 or 20
Drug: Placebo transdermal patch
Placebo to match buprenorphine transdermal patch 10 or 20.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events (AEs) as a Measure of Safety
Time Frame: 483 days
For the Run-in and double-blind phases of the study, the focus of this study was changed before unblinding to a safety study due to early termination and having enrolled only 35% of the planned sample size. Therefore, the safety data is presented for the run-in and double-blind and overall exposure to BTDS, which includes the extension phase.
483 days

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2003

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2005

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2005

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 17, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2006

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 18, 2006

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 3, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BUP3011 and BUP3011S

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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