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

Sponsor:	Purdue Pharma LP
Information provided by:	Purdue Pharma LP
ClinicalTrials.gov Identifier:	NCT00315445

Purpose

The objective of this study is to assess the safety of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system and immediate release oxycodone/ acetaminophen in subjects with chronic back pain. The double-blind treatment intervention duration is 84 days during which time supplemental analgesic medication (non-steroidal anti-inflammatory drugs) will be allowed for all subjects in addition to study drug.

Condition	Intervention	Phase
Back Pain	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 Comparative Study of Buprenorphine TDS, Oxycodone/ Acetaminophen Tablets Qid and Placebo in Patients With Chronic Back Pain

Resource links provided by NLM:

MedlinePlus related topics: Back Pain

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 the average and pain right now scores on days 1, 7, 21, 30, 45, 60, 75, 84, and, if applicable, at early termination.

Secondary Outcome Measures:

Discontinuation due to lack of efficacy
Medical Outcomes Study health survey
therapeutic response
patient preference
daily patient diary for average pain
time to stable pain management
number of post-titration dose adjustments
patient satisfaction.

Estimated Enrollment:	120
Study Start Date:	December 1997
Estimated Study Completion Date:	May 1998

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:

clinical evidence of stable, chronic (>2 months) back pain related to intervertebral disc disease, nerve root entrapment, spondylolithiasis, and osteoarthritis or other, similar nonmalignant conditions.
unacceptable pain control despite currently taking a nonsteroidal anti-inflammatory drug considered at a therapeutic and/or tolerated dose or, subjects currently taking </=2 short-acting opioid doses per day, or subjects taking 3-12 short-acting opioid doses per day.

Exclusion Criteria:

receiving opioids at an average daily dose of >90 mg of oral morphine equivalents or receiving more than 12 tablets per day of short-acting opioid-containing products.
scheduled to have surgery (including dental) involving the use of preoperative or postoperative 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: NCT00315445

Locations

United States, Alabama
Rheumatology Associates of North Alabama
Huntsville, Alabama, United States, 35801
United States, Arizona
Phoenix Orthopedic Center, Ltd.
Phoenix, Arizona, United States, 85023
Phoenix Center for Clinical Research
Phoenix, Arizona, United States, 85015
United States, Florida
SeaView Research
Miami, Florida, United States, 33134
Park Place Therapeutic Center
Plantation, Florida, United States, 33324
Gainesville Clinical Research Center
Gainesville, Florida, United States, 32605
United States, Georgia
Atlanta Research Center
Decatur, Georgia, United States, 30033
United States, Missouri
The Center for Pharmaceutical Research, P.C.
Kansas City, Missouri, United States, 64114
United States, New Jersey
New Jersey Research Foundation
Linwood, New Jersey, United States, 08221
United States, North Carolina
North Carolina Clinical Research, Inc.
Raleigh, North Carolina, United States, 27607
United States, Texas
Research Across America
Dallas, Texas, United States, 75234
Metroplex Clinical Research Center
Dallas, Texas, United States, 75235

Sponsors and Collaborators

Purdue Pharma LP

More Information

No publications provided

Study ID Numbers:	BP96-0604
Study First Received:	April 17, 2006
Last Updated:	April 29, 2006
ClinicalTrials.gov Identifier:	NCT00315445 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Purdue Pharma LP:

chronic back pain
opioid
transdermal

Additional relevant MeSH terms:

Narcotic Antagonists
Nervous System Diseases
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics
Pain
Back Pain
Pharmacologic Actions
Signs and Symptoms

Buprenorphine
Sensory System Agents
Therapeutic Uses
Neurologic Manifestations
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on November 27, 2009