Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Mod-to-Sev Osteoarthritis Pain. - Tabular View

Tracking Information
First Received Date ^ICMJE	April 17, 2006
Last Updated Date	April 29, 2006
Start Date ^ICMJE	December 2003
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: April 17, 2006)	The time from first application of double-blind treatment to the development of inadequate analgesia at the primary OA pain site.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00315458 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 17, 2006)	Pain Right Now score
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Mod-to-Sev Osteoarthritis Pain.
Official Title ^ICMJE	Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study to Determine Efficacy and Safety of Buprenorphine Transdermal System in Subjects With Mod-to-Sev Osteoarthritis Pain Requiring Daily Treatment With Opioids
Brief Summary	The objective of this study is to assess the safety and efficacy of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system in subjects with moderate to severe osteoarthritis pain. The double-blind treatment intervention duration is 12 weeks during which time supplemental analgesic medication (immediate release oxycodone) 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, Placebo Control, Parallel Assignment, Efficacy Study
Condition ^ICMJE	Osteoarthritis
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	310
Completion Date	February 2005
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria: clinical evidence of osteoarthritis of the hip, knee, or spine joint for >/= 1 year currently adequately treated with short acting opioids. taking ≥ 30 and ≤ 80 mg oral morphine or morphine equivalents per day for ≥ 2 weeks for control of their osteoarthritis pain. Exclusion Criteria: requiring frequent analgesic therapy for chronic condition(s), other than osteoarthritis of the hip, knee, or spine. scheduled for surgery of the disease site (e.g., major joint replacement surgery), or any other major surgery that would fall within the study period. Other protocol-specific exclusion/inclusion criteria may apply.
Gender	Both
Ages	40 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	NCT00315458
Responsible Party
Study ID Numbers ^ICMJE	BUP3011
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