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

Tracking Information
First Received Date ^ICMJE	April 17, 2006
Last Updated Date	April 29, 2006
Start Date ^ICMJE	December 1997
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: April 17, 2006)	Pain on the average and pain right now scores on days 1, 7, 21, 30, 45, 60, 75, 84, and, if applicable, at early termination.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00315445 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 17, 2006)	Discontinuation due to lack of efficacy Medical Outcomes Study health survey therapeutic response patient preference daily patient diary for average pain time to stable pain management number of post-titration dose adjustments patient satisfaction.
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	The Safety and Efficacy of the Buprenorphine Transdermal System in Subjects With Chronic Back Pain.
Official Title ^ICMJE	A Comparative Study of Buprenorphine TDS, Oxycodone/ Acetaminophen Tablets Qid and Placebo in Patients With Chronic Back Pain
Brief Summary	The objective of this study is to assess the safety 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 back pain. The double-blind treatment intervention duration is 84 days during which time supplemental analgesic medication (non-steroidal anti-inflammatory drugs) will be allowed for all subjects in addition to study drug.
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.
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Condition ^ICMJE	Back Pain
Intervention ^ICMJE	Drug: Buprenorphine transdermal delivery system
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	120
Completion Date	May 1998
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria: clinical evidence of stable, chronic (>2 months) back pain related to intervertebral disc disease, nerve root entrapment, spondylolithiasis, and osteoarthritis or other, similar nonmalignant conditions. unacceptable pain control despite currently taking a nonsteroidal anti-inflammatory drug considered at a therapeutic and/or tolerated dose or, subjects currently taking </=2 short-acting opioid doses per day, or subjects taking 3-12 short-acting opioid doses per day. Exclusion Criteria: receiving opioids at an average daily dose of >90 mg of oral morphine equivalents or receiving more than 12 tablets per day of short-acting opioid-containing products. scheduled to have surgery (including dental) involving the use of preoperative or postoperative analgesics or anesthetics during the study period. Other protocol-specific exclusion/inclusion criteria may apply.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00315445
Responsible Party
Study ID Numbers ^ICMJE	BP96-0604
Study Sponsor ^ICMJE	Purdue Pharma LP
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Purdue Pharma LP
Verification Date	April 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP