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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 versus a placebo patch with dummy heat in patients with mild to moderate pain associated with osteoarthritis of the knee. After screening, patients discontinue all analgesic medication (except ≤325 mg aspirin daily for cardioprotective purposes). Patients selected a target knee (right or left), and all efficacy evaluations were completed with respect to this target knee. After discontinuing analgesics for at least 48 hours, and when the average pain intensity over the previous 24 hours for the target knee was ≥40 mm using a 100 mm visual analog scale (VAS), patients were randomized in a 1:1 fashion to receive treatment with either the transdermal ketoprofen patch with CHADD heat or the placebo patch with dummy heat. Patients treated the target knee each night for 12 hours (± 1 hour) for 4 weeks. Patients returned to the study site every 7 days (± 1 day) for study evaluations. Throughout the study, patients were allowed to take up to 2000 mg acetaminophen per day as rescue medication; however, rescue medication was not allowed within the 48 hours prior to efficacy evaluations.

Official Title
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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 OA Pain of the Knee

Conditions
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Pain, Osteoarthritis, Knee

Intervention / Treatment
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* Drug: Transdermal Ketoprofen Patch with CHADD
* Drug: Placebo transdermal patch


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transdermal Ketoprofen Patch with CHADD<br> | Drug: Transdermal Ketoprofen Patch with CHADD<br>* 12 hours patch application for 28 days<br>* Other names: Matrix Transdermal Ketoprofen/CHADD Sytem;|
| Placebo Comparator: Placebo patch and a dummy heating unit<br> | Drug: Placebo transdermal patch<br>* 12 hours application for 28 days<br>* Other names: Placebo patch with dummy heating unit;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the WOMAC pain subscale score |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants wih adverse events |  | 28 days | 
| Patient Global Satisfaction score | Patient global satisfaction score at Study Visit 5 | 28 days | 
| Mean change from baseline for average pain over the last 24 hours VAS scores |  | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Osteoarthritis, OA, Mild to Moderate Osteoarthritis (OA) Pain of the Knee