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

Tracking Information
First Received Date ^ICMJE	April 10, 2006
Last Updated Date	April 29, 2006
Start Date ^ICMJE	February 2004
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: April 10, 2006)	Average pain over the last 24 hours score at Weeks 4, 8, and 12.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00313014 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 10, 2006)	The daily number of tablets of supplemental analgesic medications Oswestry Disability Index scores Medical Outcome Study Sleep Scale scores.
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Safety and Efficacy of Buprenorphine Transdermal Delivery System in Subjects With Moderate to Severe Low Back Pain.
Official Title ^ICMJE	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
Brief Summary	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.
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	Chronic Low 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	Terminated
Enrollment ^ICMJE	891
Completion Date	September 2005
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
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	NCT00313014
Responsible Party
Study ID Numbers ^ICMJE	BUP3015
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