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

Sponsor:	Purdue Pharma LP
Information provided by:	Purdue Pharma LP
ClinicalTrials.gov Identifier:	NCT00315848

Purpose

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.

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Multi-Center, Randomized, Double-Blind, Parallel Group Study of the Safety and Efficacy of Buprenorphine Transdermal Delivery System Vs. Oxycodone/Acetaminophen Tablets Vs. Placebo in Patients With Chronic Pain Due to Osteoarthritis

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Buprenorphine Buprenorphine hydrochloride

U.S. FDA Resources

Further study details as provided by Purdue Pharma LP:

Primary Outcome Measures:

Pain on average and pain right now scores at days 0, 9, 15, 30, 45, 60, or at early termination.

Secondary Outcome Measures:

Brief Pain Inventory
dropouts due to lack of efficacy
MOS health survey
VAS pain intensity
therapeutic response
patient preference
daily patient diary
and number of oxycodone/acetaminophen or placebo tablets taken

Estimated Enrollment:	225
Study Start Date:	November 1996
Estimated Study Completion Date:	December 1999

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

Criteria

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.

Other protocol-specific exclusion/inclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00315848

Locations

United States, Alabama
Rheumatology Associates of North Alabama
Huntsville, Alabama, United States, 35801
United States, Arizona
Arizona Research and Education
Phoenix, Arizona, United States, 85012
Phoenix Center for Clinical Research
Phoenix, Arizona, United States, 85015
United States, Colorado
Western Integrated Pain Treatment Centers
Westminster, Colorado, United States, 80030
United States, Florida
Gainesville Clinical Research Center
Gainesville, Florida, United States, 32605
Park Place Therapeutic Center
Plantation, Florida, United States, 33324
United States, Indiana
MediSphere Medical Research Center, L.L.C.
Evansville, Indiana, United States, 47714
United States, New York
Stratton VA Medical Center
Albany, New York, United States, 12208
United States, Texas
Metroplex Clinical Research Center
Dallas, Texas, United States, 75235
Arthritis Diagnostic and Treatment Center
San Antonio, Texas, United States, 78240

Sponsors and Collaborators

Purdue Pharma LP

More Information

No publications provided

Study ID Numbers:	BP96-0101
Study First Received:	April 18, 2006
Last Updated:	April 29, 2006
ClinicalTrials.gov Identifier:	NCT00315848 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Purdue Pharma LP:

chronic pain
osteoarthritis
opioid
transdermal

Additional relevant MeSH terms:

Osteoarthritis
Joint Diseases
Narcotic Antagonists
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics
Rheumatic Diseases
Pharmacologic Actions
Buprenorphine

Musculoskeletal Diseases
Sensory System Agents
Therapeutic Uses
Arthritis
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on November 27, 2009