Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Osteoarthritis Pain.

NCT ID: NCT00314652

Last Updated: 2006-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-06-30

Study Completion Date

1999-10-31

Brief Summary

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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 in subjects with osteoarthritis pain. The double-blind treatment intervention duration is 28 days.

Detailed Description

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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.

Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Buprenorphine transdermal delivery system

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* documented history and/or radiologic evidence of chronic osteoarthritis of the hip or knee.
* receiving opioid therapy for osteoarthritis-related pain within the past year or have experienced pain that was inadequately controlled with a full standard dose of NSAIDs.

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 or capsules 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Purdue Pharma LP

INDUSTRY

Sponsor Role lead

Locations

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Hawthorne & York, International, Ltd.

Phoenix, Arizona, United States

Site Status

Arizona Research Center, LLC

Phoenix, Arizona, United States

Site Status

ACRC/Arizona Clinical Research

Tucson, Arizona, United States

Site Status

Advanced Clinical Therapeutics

Tucson, Arizona, United States

Site Status

San Diego Arthritis and Osteoporosis Research

San Diego, California, United States

Site Status

Scripps Clinic Rancho Bernardo

San Diego, California, United States

Site Status

Clinical Research Consultants, Inc.

Trumbull, Connecticut, United States

Site Status

Tampa Bay Medical Research, Inc.

Clearwater, Florida, United States

Site Status

University Clinical Research

DeLand, Florida, United States

Site Status

Gainesville Clinical Research Center

Gainesville, Florida, United States

Site Status

Physicians Research Associates Jacksonville

Jacksonville, Florida, United States

Site Status

University Clinical Research, Inc.

Pembroke Pines, Florida, United States

Site Status

Gold Coast Research, Inc.

Weston, Florida, United States

Site Status

MediSphere Medical Research Center, LLC

Evansville, Indiana, United States

Site Status

Westside Family Medical Center

Kalamazoo, Michigan, United States

Site Status

Center for Pharmaceutical Research

Kansas City, Missouri, United States

Site Status

NJP Clinical Research

Passaic, New Jersey, United States

Site Status

PW Clinical Research, LLC

Winston-Salem, North Carolina, United States

Site Status

New Century Research Center, Ltd.

Beaverbrook, Ohio, United States

Site Status

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States

Site Status

Mid-South Clinical Research Institute

Memphis, Tennessee, United States

Site Status

Advanced Clinical Research

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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BP99-0203

Identifier Type: -

Identifier Source: org_study_id