Transdermal Ketoprofen to Treat Mild to Moderate Osteoarthritis (OA) Pain of the Knee - Tabular View

Tracking Information
First Received Date ^ICMJE	April 18, 2005
Last Updated Date	September 21, 2005
Start Date ^ICMJE	April 2005
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: June 23, 2005)	The primary objective is to assess the analgesic efficacy of transdermal ketoprofen when applied with controlled heat versus placebo in patients with mild to moderate osteoarthritis pain of the knee
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00108810 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 23, 2005)	The secondary objective is to characterize the safety of transdermal ketoprofen when administered with controlled heat
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Transdermal Ketoprofen to Treat Mild to Moderate Osteoarthritis (OA) Pain of the Knee
Official Title ^ICMJE	A Randomized, Double-Blind, Parallel, Placebo Controlled 4 Week Proof-of-Concept Study to Evaluate the Safety and Efficacy of Transdermal Ketoprofen When Administered With Controlled Heat in Patients With Mild to Moderate Osteoarthritis (OA) Pain of the Knee
Brief Summary	The purpose of the study is to evaluate the safety and effectiveness of the investigational ketoprofen patch with a controlled heating patch, compared to placebo (inactive substance) for the treatment of pain caused by osteoarthritis.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Pain Osteoarthritis, Knee
Intervention ^ICMJE	Drug: Matrix Transdermal Ketoprofen/CHADD (Controlled Heat Assisted Drug 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	120
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria: Patient is between forty (40) and seventy-five (75) years of age. Patient has clinically diagnosed radiographic evidence of osteoarthritis of the knee within the past year. Exclusion Criteria: Patient has known allergy to nonsteroidal anti-inflammatory drugs (NSAIDs) (including aspirin) or has a suspected hypersensitivity, allergy or other contraindication to any compound present in the study medication. Patient has a history of significant gastrointestinal disease or previous gastrointestinal upset following NSAID administration.
Gender	Both
Ages	40 Years to 75 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	NCT00108810
Responsible Party
Study ID Numbers ^ICMJE	ZMK-202
Study Sponsor ^ICMJE	ZARS Pharma Inc.
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	ZARS Pharma Inc.
Verification Date	September 2005
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP