Status:
COMPLETED
Transdermal Ketoprofen to Treat Mild to Moderate Osteoarthritis (OA) Pain of the Knee
Lead Sponsor:
ZARS Pharma Inc.
Conditions:
Pain
Osteoarthritis, Knee
Eligibility:
All Genders
40-75 years
Phase:
PHASE2
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...
Detailed Description
Proof-of-concept study, multicenter, randomized, double-blind, parallel-group, placebo-controlled study designed to evaluate the safety and efficacy of a transdermal ketoprofen patch with CHADD heat v...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2005
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT00108810
Start Date
April 1 2005
End Date
October 1 2005
Last Update
June 5 2012
Active Locations (5)
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1
SouthBay Pharma Research
Buena Park, California, United States, 90620
2
The Center for Rheumatology and Bone Research
Washington D.C., District of Columbia, United States, 20006
3
Radiant Research
Daytona Beach, Florida, United States, 32114
4
University Clinical Research
Pembroke Pines, Florida, United States, 33024