Safety and Efficacy of Buprenorphine Transdermal Delivery System in Subjects With Chronic Non-Malignant Pain - Full Text View

Sponsors and Collaborators:	Purdue Pharma LP Napp Pharmaceuticals Limited
Information provided by:	Purdue Pharma LP
ClinicalTrials.gov Identifier:	NCT00312195

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 matching placebo transdermal system in subjects with chronic non-malignant pain syndromes currently controlled by oral opioids. The double-blind treatment intervention duration is 2 weeks during which time supplemental analgesic medication (acetaminophen) will be provided to all subjects in addition to study drug.

Condition	Intervention	Phase
Chronic Non-Malignant Pain	Drug: Buprenorphine transdermal delivery system	Phase III

Drug Information available for: Buprenorphine Buprenorphine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	An Open-Label Run-in, Followed by a Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Show the Effectiveness of Buprenorphine Transdermal System in Management of Patients With Chronic Non-Malignant Pain Syndromes

Further study details as provided by Purdue Pharma LP:

Primary Outcome Measures:

Percentage randomized subjects with ineffective treatment.

Secondary Outcome Measures:

Time to ineffective treatment
the percentage of subjects who had ineffective treatment or who discontinued due to any reasons other than ineffective treatment
and the amount of rescue medication used for pain (average daily number of acetaminophen tablets).

Estimated Enrollment:	240
Study Start Date:	March 2001
Estimated Study Completion Date:	July 2001

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:

At least 2 month's history of non-malignant pain, currently in stable pain control on opioid therapy.
Good, very good or excellent pain control on current opioid therapy.
Willing and able to use a telephone interactive voice response service.

Exclusion Criteria:

Currently receiving daily morphine or oxycodone mono-therapy.
Scheduled for surgery of the disease site (eg, major joint replacement surgery), or any other major surgery, which would fall within the study period.

Other protocol-specific exclusion/inclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00312195

Show 42 Study Locations

Sponsors and Collaborators

Purdue Pharma LP

Napp Pharmaceuticals Limited

More Information

Study ID Numbers:	BUP3201
Study First Received:	April 5, 2006
Last Updated:	April 29, 2006
ClinicalTrials.gov Identifier:	NCT00312195
Health Authority:	United States: Food and Drug Administration

Keywords provided by Purdue Pharma LP:

Chronic pain
opioid
transdermal

Study placed in the following topic categories:

Buprenorphine
Pain

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Narcotic Antagonists
Physiological Effects of Drugs
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