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

Sponsored by:	Purdue Pharma LP
Information provided by:	Purdue Pharma LP
ClinicalTrials.gov Identifier:	NCT00315887

Purpose

The objective of this study is to assess the safety and efficacy of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system and hydrocodone/acetaminophen in subjects with chronic back pain. The double-blind treatment intervention duration is 56 days during which time supplemental analgesic medication (ibuprofen) will be provided to all subjects in addition to study drug.

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

MedlinePlus related topics: Back Pain

Drug Information available for: Buprenorphine Buprenorphine hydrochloride Acetaminophen Hydrocodone Hydrocodone bitartrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Double-Blind Comparative Study of Buprenorphine Transdermal System (BTDS) and Hydrocodone/Acetaminophen Tablets in Patients With Chronic Back Pain

Further study details as provided by Purdue Pharma LP:

Primary Outcome Measures:

Patient Satisfaction With Medication for Pain and Average Pain Intensity scores on days 0, 7, 14, 21, 28, 35, 42, 49, 56 and, if applicable, at early termination.

Secondary Outcome Measures:

Average Pain Intensity and Patient Satisfaction With Medication for Pain scores (Patient Global Efficacy Rating)
incidence of and time to early discontinuation due to lack of efficacy
investigator’s assessment of therapeutic response
dose level at the end of titration

Estimated Enrollment:	250
Study Start Date:	April 1999
Estimated Study Completion Date:	October 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:

clinical evidence of chronic back pain related to intervertebral disc disease, nerve root entrapment, spondylolithesis, osteoarthritis, or other, similar nonmalignant conditions.
back pain treated with an opioid-containing analgesic at a dose equal to or less than the equivalent of 90 mg of oral morphine per day or 12 or fewer capsules or tablets of an opioid combination analgesic per day.

Exclusion Criteria:

receiving opioids at an average daily dose of greater than 90 mg of oral morphine equivalents or patients receiving more than 12 tablets per day of short-acting opioid-containing products.
scheduled to have surgery (including dental) during the study period that involved the use of pre- and/or postoperative analgesics or anesthetics.

Other protocol-specific exclusion/inclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00315887

Show 22 Study Locations

Sponsors and Collaborators

Purdue Pharma LP

More Information

Study ID Numbers:	BP98-1201
Study First Received:	April 18, 2006
Last Updated:	May 1, 2006
ClinicalTrials.gov Identifier:	NCT00315887
Health Authority:	United States: Food and Drug Administration

Keywords provided by Purdue Pharma LP:

low back pain
opioid
transdermal

Study placed in the following topic categories:

Signs and Symptoms
Buprenorphine
Hydrocodone
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