Safety and Efficacy of Dose Conversion From Vicodin® to Buprenorphine Transdermal System in Subjects With Osteoarthritis - Tabular View

Tracking Information
First Received Date ^ICMJE	April 7, 2006
Last Updated Date	November 13, 2006
Start Date ^ICMJE	June 2003
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: April 7, 2006)	Completion of the 14-day double-blind phase.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00312572 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 29, 2006)	Proportion of days a subject had successful analgesia rate of premature discontinuation mean daily average pain over last 24 hours score WOMAC Osteoarthritis Index score Medical Outcome Study Sleep Scale score and treatment satisfaction survey
Original Secondary Outcome Measures ^ICMJE (submitted: April 7, 2006)	Proportion of days a subject had successful analgesia. Rate of premature discontinuation. Mean daily average pain over last 24 hours score. WOMAC Osteoarthritis Index score. Medical Outcome Study Sleep Scale score. Treatment satisfaction survey.

Descriptive Information
Brief Title ^ICMJE	Safety and Efficacy of Dose Conversion From Vicodin® to Buprenorphine Transdermal System in Subjects With Osteoarthritis
Official Title ^ICMJE	A Randomized, Double-Blind Study Evaluating the Dose Conversion From Vicodin® to Buprenorphine Transdermal System (BTDS) in Subjects With Osteoarthritis (OA) Pain
Brief Summary	The objective of this study is to evaluate the safety and efficacy of dose conversion from hydrocodone/ acetaminophen (Vicodin®) to the buprenorphine transdermal system in subjects with osteoarthritis pain of the hip or knee. The double-blind treatment intervention duration is 2 weeks during which time supplemental analgesic medication will be allowed.
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	Allocation: Randomized Control: Active Control Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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	Completed
Enrollment ^ICMJE	200
Completion Date	July 2004
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria: - osteoarthritis of the hip or knee taking a regularly scheduled regimen of hydrocodone/ acetaminophen for their OA pain. Exclusion Criteria: currently have condition requiring a stable regimen of APAP. a history of chronic conditions, other than OA of the hip or knee joints, requiring frequent, intermittent analgesic therapy. Other protocol-specific exclusion/inclusion criteria may apply.
Gender	Both
Ages	40 Years to 85 Years
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	NCT00312572
Responsible Party
Study ID Numbers ^ICMJE	BUP3018
Study Sponsor ^ICMJE	Purdue Pharma LP
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Purdue Pharma LP
Verification Date	November 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP