The Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Osteoarthritis Pain.

This study has been completed.

Sponsor:

Information provided by:

Purdue Pharma LP

ClinicalTrials.gov Identifier:

NCT00315848

First received: April 18, 2006

Last updated: April 29, 2006

Last verified: April 2006

History of Changes

Tracking Information
First Received Date ^ICMJE	April 18, 2006
Last Updated Date	April 29, 2006
Start Date ^ICMJE	November 1996
Primary Completion Date	Not Provided
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 at early termination.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00315848 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
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	The Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Osteoarthritis Pain.
Official Title ^ICMJE	A Multi-Center, Randomized, Double-Blind, Parallel Group Study of the Safety and Efficacy of Buprenorphine Transdermal Delivery System Vs. Oxycodone/Acetaminophen Tablets Vs. Placebo in Patients With Chronic Pain Due to Osteoarthritis
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 osteoarthritis 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 Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized 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 Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	225
Completion Date	December 1999
Primary Completion Date	Not Provided
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 Number ^ICMJE	NCT00315848
Other Study ID Numbers ^ICMJE	BP96-0101
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Purdue Pharma LP
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
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

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