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Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Osteoarthritis Pain

NCT ID: NCT00312221

Last Updated: 2012-09-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

418 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2005-08-31

Brief Summary

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The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (20 mg) in comparison to the buprenorphine transdermal system (5 mg) and oxycodone immediate release in subjects with moderate to severe osteoarthritis pain currently treated with oral opioids. The double-blind treatment intervention duration is 12 weeks during which time supplemental analgesic medication (acetaminophen, ibuprofen, immediate release oxycodone) will be provided to all subjects in addition to study drug.

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.

Conditions

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Osteoarthritis

Keywords

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Osteoarthritis, opioid, transdermal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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BTDS 5

Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear

Group Type ACTIVE_COMPARATOR

Buprenorphine

Intervention Type DRUG

Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear

BTDS 20

Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear

Group Type EXPERIMENTAL

Buprenorphine

Intervention Type DRUG

Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear

Oxycodone Immediate-Release (Oxy IR) 40 mg

Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).

Group Type EXPERIMENTAL

oxycodone immediate-release

Intervention Type DRUG

Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).

Interventions

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Buprenorphine

Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear

Intervention Type DRUG

Buprenorphine

Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear

Intervention Type DRUG

oxycodone immediate-release

Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).

Intervention Type DRUG

Other Intervention Names

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Butrans™ Butrans™

Eligibility Criteria

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Inclusion Criteria

* Osteoarthritis of the hip, knee, or spine for 1 year or longer, confirmed by radiographic evidence within the last 2 years.
* Good pain control while on a stable dose of an opioid analgesic for osteoarthritis.

Exclusion Criteria

* Not currently taking and tolerating opioids.
* Taking more than 80 mg per day of oral morphine sulfate or equivalent within 30 days of enrollment.
* Requiring frequent analgesic therapy for chronic condition(s), in addition to osteoarthritis.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Purdue Pharma LP

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Parkway Medical Center

Birmingham, Alabama, United States

Site Status

International Clinical Research Network

Chula Vista, California, United States

Site Status

Clinical Trials Research

Roseville, California, United States

Site Status

Accelovance

San Diego, California, United States

Site Status

Torrance Clinical Research

Torrance, California, United States

Site Status

Southern Colorado Clinic

Pueblo, Colorado, United States

Site Status

Drug Study Institute

Jupiter, Florida, United States

Site Status

Innovative Research of West Florida, Inc.

Largo, Florida, United States

Site Status

International Medical Research

Ormond Beach, Florida, United States

Site Status

Peninsula Research, Inc.

Ormond Beach, Florida, United States

Site Status

Palm Beach Research Center

West Palm Beach, Florida, United States

Site Status

Georgia Medical Research Institute

Marietta, Georgia, United States

Site Status

Non- Surgical Orthopedic & Spine Center, P.C.

Marietta, Georgia, United States

Site Status

The Arthritis Center

Springfield, Illinois, United States

Site Status

Commonwealth Biomedical Research, LLC

Madisonville, Kentucky, United States

Site Status

Miray Medical Center

Brockton, Massachusetts, United States

Site Status

Professional Clinical Research Crystal Lake Health Center

Benzonia, Michigan, United States

Site Status

Rheumatology PC

Kalamazoo, Michigan, United States

Site Status

Pharm Quest

Greensboro, North Carolina, United States

Site Status

The Clinical Trial Center, LLC

Jenkintown, Pennsylvania, United States

Site Status

Amarillo Center for Clinical Research

Amarillo, Texas, United States

Site Status

Med Search Professional Group/Pharmaceutical C-Trials Inc.

Hurst, Texas, United States

Site Status

Texas Medical Research Associates

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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BUP3019

Identifier Type: -

Identifier Source: org_study_id