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

Tracking Information
First Received Date ^ICMJE	April 18, 2006
Last Updated Date	April 29, 2006
Start Date ^ICMJE	April 1997
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: April 18, 2006)	Pain on average and pain right now scores at days 0, 9, 15, 30, 45, 60, or if applicable, at early termination.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00315874 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 29, 2006)	Brief Pain Inventory dropouts due to lack of efficacy MOS health survey VAS pain intensity therapeutic response patient preference daily patient diary and number of oxycodone/acetaminophen or placebo tablets taken
Original Secondary Outcome Measures ^ICMJE (submitted: April 18, 2006)	brief Pain Inventory dropouts due to lack of efficacy MOS health survey VAS pain intensity therapeutic response patient preference daily patient diary number of oxycodone/acetaminophen or placebo tablets taken

Descriptive Information
Brief Title ^ICMJE	The Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Chronic Low Back Pain.
Official Title ^ICMJE	Safety and Efficacy of Buprenorphine TDS (Transdermal Delivery System) 5, 10 and 20 Applied Every 7 Days for Sixty Days Vs. 5 Mg Oxycodone/325 Mg Acetaminophen Tablets q6h Prn Vs. Placebo in Patients With Chronic Low Back Pain
Brief Summary	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 placebo transdermal system and immediate release oxycodone/acetaminophen in subjects with chronic low back pain inadequately treated with non-opioid analgesics. The double-blind treatment intervention duration is 60 days.
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	225
Completion Date	January 1998
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria: unacceptable pain control despite currently taking a nonsteroidal anti-inflammatory drug considered at a therapeutic and/or tolerated dose or currently taking </=2 short-acting opioid doses per day. taking >/=3 opioid doses per day with or without acceptable pain control. Exclusion Criteria: receiving opioids at an average daily dose of greater than 60 mg of oral morphine equivalents or subjects receiving more than 6 tablets per day of a short-acting opioid. scheduled to have surgery (including dental) involving the use of post- or preoperative 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	NCT00315874
Responsible Party
Study ID Numbers ^ICMJE	BP96-0102
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