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

Sponsored by:	Purdue Pharma LP
Information provided by:	Purdue Pharma LP
ClinicalTrials.gov Identifier:	NCT00315874

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
Study 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 January 16, 2009