Transdermal Ketoprofen to Treat Mild to Moderate Osteoarthritis (OA) Pain of the Knee - Article Degenerative Joint Disease; Osteoarthritis arthritis
Clinical Trial: Transdermal Ketoprofen to Treat Mild to Moderate Osteoarthritis (OA) Pain of the Knee
This study is currently recruiting patients.
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|
| 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
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
Ages Eligible for Study: 40 Years - 75 Years, Genders Eligible for Study: Both
- 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.
- 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
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
Radiant Research, Daytona Beach, Florida, 32114, United States; Recruiting
Shirley Cowell 386.257.5717 Ext. 308
University Clinical Research, Pembroke Pines, Florida, 33024, United States; Recruiting
Susan Rook 954.437.5988
Hospital for Special Surgery, New York City, New York, 10021, United States; Recruiting
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
Cache Date: May 4, 2005