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.

Condition	Treatment or Intervention	Phase
Pain Osteoarthritis, Knee	Drug: Matrix Transdermal Ketoprofen/CHADD (Controlled Heat Assisted Drug Delivery) System	Phase II

Further Study Details: 

Primary Outcomes: 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
Secondary Outcomes: The secondary objective is to characterize the safety of transdermal ketoprofen when administered with controlled heat
Expected Total Enrollment:  120

Ages Eligible for Study:  40 Years   -   75 Years,  Genders Eligible for Study:  Both

Criteria

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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00108810

Matthew Iverson      (801) 350-0202    miverson@zars.com

California
      SouthBay Pharma Research, Buena Park,  California,  90620,  United States; Recruiting
District of Columbia
      The Center for Rheumatology and Bone Research, Washington,  District of Columbia,  20006,  United States; Recruiting
Florida
      Radiant Research, Daytona Beach,  Florida,  32114,  United States; Recruiting
      University Clinical Research, Pembroke Pines,  Florida,  33024,  United States; Recruiting
New York
      Hospital for Special Surgery, New York City,  New York,  10021,  United States; Recruiting

Study ID Numbers:  ZMK-202
Record last reviewed:  April 2005
Last Updated:  April 26, 2005
Record first received:  April 18, 2005
ClinicalTrials.gov Identifier:  NCT00108810
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-05-03