Clinical Trial: Transdermal Ketoprofen to Treat Mild to Moderate Osteoarthritis (OA) Pain of the Knee

This study is currently recruiting patients.

Sponsored by: ZARS, Inc.
Information provided by: ZARS, Inc.

Purpose

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

MedlinePlus related topics:  Osteoarthritis;   Pain

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title: 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

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

Study start: April 2005

Eligibility

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.

Location and Contact Information

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
Violet Luiszer  714-827-1899    Southbayparma@aol.com 

District of Columbia
      The Center for Rheumatology and Bone Research, Washington,  District of Columbia,  20006,  United States; Recruiting
Lalita Blue  202-293-1470  Ext. 31    lblue@arapc.com 

Florida
      Radiant Research, Daytona Beach,  Florida,  32114,  United States; Recruiting
Sharon Daly  386-257-5717  Ext. 308    sharondaly@radiantresearch.com 
Shirley Cowell  386.257.5717  Ext. 308 

      University Clinical Research, Pembroke Pines,  Florida,  33024,  United States; Recruiting
Crystal Derienzo  954-437-5988 
Susan Rook  954.437.5988 

New York
      Hospital for Special Surgery, New York City,  New York,  10021,  United States; Recruiting
Peggy O'Donohue  212-774-2271    odonohuem@hss.edu 

More Information

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


Source: ClinicalTrials.gov
Cache Date: May 4, 2005

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