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

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 chronic low back pain inadequately treated with non-opioid analgesics. The double-blind treatment intervention duration is 60 days.

Condition	Intervention	Phase
Back Pain	Drug: Buprenorphine transdermal delivery system	Phase III

MedlinePlus related topics:

Back Pain

Drug Information available for:

Oxycodone Oxycodone hydrochloride Buprenorphine Buprenorphine hydrochloride Acetaminophen

U.S. FDA Resources

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

Official Title:	Safety and Efficacy of Buprenorphine TDS (Transdermal Delivery System) 5, 10 and 20 Applied Every 7 Days for Sixty Days Vs. 5 Mg Oxycodone/325 Mg Acetaminophen Tablets q6h Prn Vs. Placebo in Patients With Chronic Low Back Pain

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 if applicable, 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:	April 1997
Estimated Study Completion Date:	January 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:

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: NCT00315874

Locations


United States, Arizona
	Arizona Research & Education
	Phoenix, Arizona, United States, 85012
	Hawthorne & York, Intl, Ltd
	Phoenix, Arizona, United States, 85008

United States, Florida
	Gainesville Clinical Research Center
	Gainesville, Florida, United States, 32605
	Park Place Therapeutic Center
	Plantation, Florida, United States, 33324

United States, Georgia
	Atlanta Research Center
	Atlanta, Georgia, United States, 30033

United States, Indiana
	Rheumatology Associates, Inc.
	Indianapolis, Indiana, United States, 46260

United States, Michigan
	Westside Family Medical Center
	Kalamazoo, Michigan, United States, 49009

United States, Missouri
	The Center for Pharmaceutical Research
	Kansas City, Missouri, United States, 64114

United States, New York
	The New York Hospital Cornell Medical Center
	New York, New York, United States, 10021

United States, North Carolina
	NC Clinical Research, Inc.
	Raleigh, North Carolina, United States, 27607
	Pain Control Ctr Bowman Gray School of Med
	Winston-Salem, North Carolina, United States, 27103

United States, Texas
	Metroplex Clinical Research Center
	Dallas, Texas, United States, 75235

Sponsors and Collaborators

Purdue Pharma LP

More Information

Study ID Numbers:	BP96-0102
First Received:	April 18, 2006
Last Updated:	April 29, 2006
ClinicalTrials.gov Identifier:	NCT00315874
Health Authority:	United States: Food and Drug Administration

Keywords provided by Purdue Pharma LP:

chronic back pain

opioid

transdermal

Study placed in the following topic categories:

Signs and Symptoms

Buprenorphine

Oxycodone

Neurologic Manifestations

Low Back Pain

Pain

Back Pain

Acetaminophen

Additional relevant MeSH terms:

Sensory System Agents

Therapeutic Uses

Narcotic Antagonists

Physiological Effects of Drugs

Nervous System Diseases

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:	NCT00315874