Safety and Efficacy of Buprenorphine Transdermal Delivery System in Subjects With Moderate to Severe Low Back Pain. - Full Text View

Sponsored by:	Purdue Pharma LP
Information provided by:	Purdue Pharma LP
ClinicalTrials.gov Identifier:	NCT00313014

Purpose

The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (20mg) in comparison to the buprenorphine transdermal system (5mg) and oxycodone immediate release in subjects with moderate to severe low back pain currently treated with oral opioids. The double-blind treatment intervention duration is 12 weeks during which time supplemental analgesic medication (acetaminophen, 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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Multicenter, Randomized, Double-Blind, Active Comparator Study to Determine the Efficacy and Safety of BTDS 20 or OxyIR Versus BTDS 5 in Subjects With Moderate to Severe Low Back Pain

Further study details as provided by Purdue Pharma LP:

Primary Outcome Measures:

Average pain over the last 24 hours score at Weeks 4, 8, and 12.

Secondary Outcome Measures:

The daily number of tablets of supplemental analgesic medications
Oswestry Disability Index scores
Medical Outcome Study Sleep Scale scores.

Estimated Enrollment:	891
Study Start Date:	February 2004
Estimated Study Completion Date:	September 2005

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:

low back pain for 3 months or longer, confirmed by radiographic evidence.
receiving a stable dose of an opioid analgesic for low back pain.

Exclusion Criteria:

taking more than 80 mg per day of oral morphine sulfate or equivalent within 30 days of enrollment.
requiring frequent analgesic therapy for chronic condition(s), in addition to low back pain.

Other protocol-specific exclusion/inclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00313014

Show 85 Study Locations

Sponsors and Collaborators

Purdue Pharma LP

More Information

No publications provided

Study ID Numbers:	BUP3015
Study First Received:	April 10, 2006
Last Updated:	April 29, 2006
ClinicalTrials.gov Identifier:	NCT00313014 History of Changes
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:

Oxycodone
Narcotic Antagonists
Low Back Pain
Central Nervous System Depressants
Pain
Narcotics
Back Pain

Signs and Symptoms
Buprenorphine
Neurologic Manifestations
Analgesics
Peripheral Nervous System Agents
Analgesics, Opioid

Additional relevant MeSH terms:

Narcotic Antagonists
Nervous System Diseases
Physiological Effects of Drugs
Central Nervous System Depressants
Low Back Pain
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 May 07, 2009