Transdermal Ketoprofen to Treat Mild to Moderate Osteoarthritis (OA) Pain of the Knee
Information source: ZARS Pharma Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain; Osteoarthritis, Knee
Intervention: Matrix Transdermal Ketoprofen/CHADD (Controlled Heat Assisted Drug Delivery) System (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: ZARS Pharma Inc.
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.
Clinical Details
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
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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 outcome: The secondary objective is to characterize the safety of transdermal ketoprofen when administered with controlled heat
Eligibility
Minimum age: 40 Years.
Maximum age: 75 Years.
Gender(s): 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.
Locations and Contacts
SouthBay Pharma Research, Buena Park, California 90620, United States
The Center for Rheumatology and Bone Research, Washington, District of Columbia 20006, United States
Radiant Research, Daytona Beach, Florida 32114, United States
University Clinical Research, Pembroke Pines, Florida 33024, United States
Hospital for Special Surgery, New York City, New York 10021, United States
Additional Information
Starting date: April 2005
Last updated: September 21, 2005
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