Safety and Efficacy of Buprenorphine Transdermal Delivery System in Subjects With Mod-to-Sev Osteoarthritis Pain - Full Text View

Purpose

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.

Condition	Intervention	Phase
Osteoarthritis	Drug: Buprenorphine transdermal delivery system	Phase III

MedlinePlus related topics:

Osteoarthritis

Drug Information available for:

Oxycodone Oxycodone hydrochloride Buprenorphine Buprenorphine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

Official Title:	Randomized, Double-Blind, Multicenter, Active Comparator Study to Determine the Efficacy and Safety of BTDS 20 or OxyIR Versus BTDS 5 in Subjects With Moderate to Severe Osteoarthritis (OA) Pain

Further study details as provided by Purdue Pharma LP:

Primary Outcome Measures:

Average pain over the last 24 hours score at Weeks 4, 8, and 12.

Secondary Outcome Measures:

Average pain and worst pain scores, supplemental analgesic medication use.

Estimated Enrollment:	858
Study Start Date:	April 2004
Estimated Study Completion Date:	August 2005

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Other protocol-specific exclusion/inclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00312221

Locations


United States, Alabama
	Parkway Medical Center
	Birmingham, Alabama, United States, 35215

United States, California
	Torrance Clinical Research
	Torrance, California, United States, 90505
	International Clinical Research Network
	Chula Vista, California, United States, 91910
	Accelovance
	San Diego, California, United States, 92108
	Clinical Trials Research
	Roseville, California, United States, 95661

United States, Colorado
	Southern Colorado Clinic
	Pueblo, Colorado, United States, 81008

United States, Florida
	Palm Beach Research Center
	West Palm Beach, Florida, United States, 33409
	Drug Study Institute
	Jupiter, Florida, United States, 33458
	Peninsula Research, Inc.
	Ormond Beach, Florida, United States, 32174
	Innovative Research of West Florida, Inc.
	Largo, Florida, United States, 33770
	International Medical Research
	Ormond Beach, Florida, United States, 32174

United States, Georgia
	Georgia Medical Research Institute
	Marietta, Georgia, United States, 30060
	Non- Surgical Orthopedic & Spine Center, P.C.
	Marietta, Georgia, United States, 30060

United States, Illinois
	The Arthritis Center
	Springfield, Illinois, United States, 62704

United States, Kentucky
	Commonwealth Biomedical Research, LLC
	Madisonville, Kentucky, United States, 42431

United States, Massachusetts
	Miray Medical Center
	Brockton, Massachusetts, United States, 23010

United States, Michigan
	Professional Clinical Research Crystal Lake Health Center
	Benzonia, Michigan, United States, 49616
	Rheumatology PC
	Kalamazoo, Michigan, United States, 49009

United States, North Carolina
	Pharm Quest
	Greensboro, North Carolina, United States, 27401

United States, Pennsylvania
	The Clinical Trial Center, LLC
	Jenkintown, Pennsylvania, United States, 19046

United States, Texas
	Texas Medical Research Associates
	San Antonio, Texas, United States, 78238
	Amarillo Center for Clinical Research
	Amarillo, Texas, United States, 79124
	Med Search Professional Group/Pharmaceutical C-Trials Inc.
	Hurst, Texas, United States, 76054

Sponsors and Collaborators

Purdue Pharma LP

More Information

Study ID Numbers:	BUP3019
First Received:	April 6, 2006
Last Updated:	April 29, 2006
ClinicalTrials.gov Identifier:	NCT00312221
Health Authority:	United States: Food and Drug Administration

Keywords provided by Purdue Pharma LP:

Osteoarthritis, opioid, transdermal

Study placed in the following topic categories:

Buprenorphine

Musculoskeletal Diseases

Osteoarthritis

Joint Diseases

Arthritis

Oxycodone

Pain

Rheumatic Diseases

Additional relevant MeSH terms:

Sensory System Agents

Therapeutic Uses

Narcotic Antagonists

Physiological Effects of Drugs

Central Nervous System Depressants

Narcotics

Peripheral Nervous System Agents

Analgesics

Central Nervous System Agents

Pharmacologic Actions

Analgesics, Opioid

ClinicalTrials.gov processed this record on November 20, 2008

Sponsored by:	Purdue Pharma LP
Information provided by:	Purdue Pharma LP
ClinicalTrials.gov Identifier:	NCT00312221