Safety of BTDS in Subjects With Osteoarthritic (OA) Pain of Hip or Knee: A 6-Month Open-label Extension Phase

August 27, 2012 updated by: Purdue Pharma LP

Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study of the Efficacy and Safety of Buprenorphine Transdermal System (BTDS) in Subjects With Mod to Sev OA Pain of Hip or Knee: A 6-Month Open-label Extension Phase

The purpose of the extension phase is to evaluate the long-term safety and tolerability of buprenorphine transdermal system (BTDS).

Study Overview

Status

Status

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

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. 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

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.
290

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
    • Arizona
      • Mesa, Arizona, United States, 85206
        • Vista Medical Research Inc.
      • Phoenix, Arizona, United States, 85023
        • Arizona Research Center
      • Phoenix, Arizona, United States, 85012
        • Arthrocare, Arthritis Care and Research
      • Phoenix, Arizona, United States, 85015
        • Arizona Rheumatology Ctr and Phoenix Ctr for Clinical Research
      • Tucson, Arizona, United States, 85712
        • Research Facility
    • California
      • Bakersfield, California, United States, 93311
        • Advanced Pain Medicine
      • Cypress, California, United States, 90630
        • Orange County Clinical Research
      • San Diego, California, United States, 92120
        • San Diego Arthritis & Osteoporosis Medical Clinic
      • San Diego, California, United States, 92128
        • Research Facility
      • San Francisco, California, United States, 94121
        • Research Facility
    • Colorado
      • Denver, Colorado, United States, 80209
        • Research Facility
      • Westminster, Colorado, United States, 80031
        • Research Facility
    • Connecticut
      • Bridgeport, Connecticut, United States, 06606
        • Research Facility
    • Florida
      • Atlantis, Florida, United States, 33462
        • Research Facility
      • Daytona Beach, Florida, United States, 32114
        • Allergy, Asthma, Arthritis & Lung
      • Deland, Florida, United States, 32720
        • University Clinical Research Deland
      • Jupiter, Florida, United States, 33458
        • Research Facility
      • Orange City, Florida, United States, 32763
        • Coastal Medical Research
      • Plantation, Florida, United States, 33324
        • Research Facility
      • West Palm Beach, Florida, United States, 33409
        • Research Facility
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Research Facility
    • Indiana
      • Columbus, Indiana, United States, 47201
        • Research Facility
      • Evansville, Indiana, United States, 47712
        • Research Facility
    • Kentucky
      • Murray, Kentucky, United States, 42071
        • Primary Care Medical Center
    • Michigan
      • Cadillac, Michigan, United States, 49601
        • Great Lakes Family Care
      • Traverse City, Michigan, United States, 49684
        • Research Facility
    • New York
      • New York, New York, United States, 10021
        • Beth Israel/Dept. of Pain
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Research Facility
    • Pennsylvania
      • Cresson, Pennsylvania, United States, 16630
        • Research Facility
      • Duncansville, Pennsylvania, United States, 16635
        • Altoona Center for Clinical Research
      • State College, Pennsylvania, United States, 16801
        • University Orthopedics & Sport Medicine Center
      • West Reading, Pennsylvania, United States, 19611
        • Research Facility
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Low Country Rheumatology, PA
    • South Dakota
      • Watertown, South Dakota, United States, 57201
        • Central Plains Clin-Brown Site
    • Texas
      • Dallas, Texas, United States, 75251
        • Research Facility
      • Harker Heights, Texas, United States, 76548
        • Research Facility
      • San Antonio, Texas, United States, 78217
        • Research Facility
      • Seguin, Texas, United States, 78155
        • Research Facility
    • Utah
      • West Valley City, Utah, United States, 84120
        • Granger Medical Clinic
    • Virginia
      • Virginia Beach, Virginia, United States, 23454
        • Hilltop Medical Center
    • Washington
      • Bellevue, Washington, United States, 98026
        • Research Facility
      • Tacoma, Washington, United States, 98405
        • Internal Medicine Northwest

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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects with moderate to severe osteoarthritic (OA) pain who completed all visits of the double-blind phase on study drug, or who discontinued study drug due to lack of therapeutic effect in the double-blind phase, but still completed all visits of the double-blind phase off study drug, are eligible to enroll in the extension phase.

Exclusion Criteria:

  • Excluded from the study are subjects who ingest > 2500 mg/day acetaminophen as part of their current stable nonopioid analgesic regimen.
  • Subjects requiring long-acting opioid analgesics [once- or twice-daily dosing with an every (q) 24 hour (h) or q12h drug] or transdermal fentanyl during the extension phase should be discontinued from the study.

Refer to core study for additional inclusion/exclusion information.

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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 patch
Drug: Buprenorphine transdermal patch
Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
Drug: Buprenorphine transdermal patch
Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
Drug: Buprenorphine transdermal patch
Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear

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
The Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time Frame: 6 months.
Safety was assessed using reports of adverse events, clinical laboratory results, findings from physical examinations, and vital sign measurements.
6 months.

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.
April 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.
July 1, 2004

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.
July 1, 2004

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).
June 2, 2010

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.
June 9, 2010

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.
June 10, 2010

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.
  • BUP3012S

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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