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

NCT ID: NCT00315848

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

225 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-11-30

Study Completion Date

1999-12-31

Brief Summary

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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 osteoarthritis pain inadequately treated with non-opioid analgesics. The double-blind treatment intervention duration is 60 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

* 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.
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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Rheumatology Associates of North Alabama

Huntsville, Alabama, United States

Site Status

Arizona Research and Education

Phoenix, Arizona, United States

Site Status

Phoenix Center for Clinical Research

Phoenix, Arizona, United States

Site Status

Western Integrated Pain Treatment Centers

Westminster, Colorado, United States

Site Status

Gainesville Clinical Research Center

Gainesville, Florida, United States

Site Status

Park Place Therapeutic Center

Plantation, Florida, United States

Site Status

MediSphere Medical Research Center, L.L.C.

Evansville, Indiana, United States

Site Status

Stratton VA Medical Center

Albany, New York, United States

Site Status

Metroplex Clinical Research Center

Dallas, Texas, United States

Site Status

Arthritis Diagnostic and Treatment Center

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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BP96-0101

Identifier Type: -

Identifier Source: org_study_id