A Study to Assess Efficacy and Safety of the Ketoprofen vs Diclofenac

Study Overview
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Brief Summary
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Primary objective: • To assess therapeutic efficacy of the Ketoprofen compared with Diclofenac based on the assessment of primary endpoint : Mean change in walking arthritis pain intensity score Secondary objectives: To assess therapeutic efficacy of the Ketoprofen compared with Diclofenac based on the assessment of secondary endpoints. To assess safety and tolerability of the Ketoprofen compared with Diclofenac based on the nature and frequency of adverse events in treatment groups

Detailed Description
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This trial is designed as an open-label, multicenter, randomized, clinical study for assessment of efficacy and safety of Ketoprofen plaster and Diclofenac plaster in patients with osteoarthritis

Official Title
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A Study to Comparing the Efficacy and Safety of the Ketoprofen and Diclofenac in Patients With Osteoarthritis

Conditions
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Osteoarthritis

Intervention / Treatment
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* Drug: Ketoprofen topical
* Drug: Diclofenac Topical


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 40-75 years Compliance to ACR diagnostic criteria of OA of the knee Patients with Kellgren-Lawrence grade 1-3 Index knee pain should be ≥40 mm on VAS (100mm) scale Exclusion Criteria: Intolerance or allergic reactions to the study therapy Usage of NSAIDs within 3 days Open skin lesions or dermatological conditions at the site of plaster application Surgery or major trauma of the index knee within the previous 12 months Pregnant or breast-feeding women Alcohol addiction, drug addiction or drug abuse in the past

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ketoprofen<br> | Drug: Ketoprofen topical<br>* Ketoprofen topical for 21days<br>|
| Active Comparator: Diclofenac<br> | Drug: Diclofenac Topical<br>* Diclofenac topical for 21days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in walking arthritis pain intensity score | Pain will be assessed by a horizontal 100 mm Visual Analogue Scale (VAS) | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in spontaneous arthritis pain intensity score | Pain will be assessed by a horizontal 100 mm Visual Analogue Scale (VAS) | 3 weeks | 
| Knee injury and Osteoarthritis Outcome Score (KOOS) | Mean change in individual parameters and the general normalized Knee injury and Osteoarthritis Outcome Score (KOOS) score (5-point scale) | 3 weeks | 
| Global Impression of Improvement (PGI-I) | Patient Global Impression of Improvement (PGI-I) assessment | 3 weeks | 
| Adverse events | frequency, severity, relationship with the study drug | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ketoprofen, diclofenac, osteoarthritis