Efficacy and Safety Study in Patients Suffering From Knee Osteoarthritis

Study Overview
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Brief Summary
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The primary objective of this study is to compare a combination of hyaluronic acid and chondroitin sulfate (V0220) to Hyalgan® on pain relief in patients with symptomatic knee osteoarthritis (OA) over 24 weeks when administered in three weekly injections. Chondroitin sulfate is one of the components of cartilage. Studies have shown that chondroitin sulphate improves the quality of the hyaluronic acid produced in the joint. The benefit of V0220 combination is based on two main physicochemical properties, in line with the characteristics of osteoarthritic disease: optimising the rheological behaviour and improving the buffering effect on synovial flow (outflow buffering).

Official Title
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Comparative Study of Efficacy and Safety of Three Intra Articular Injections of V0220 Versus Hyalgan® in Patients Suffering From Symptomatic Knee Osteoarthritis. A Multinational Multicentric, Randomised, Double-blind, Parallel-group Study

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Device: Chondroitin sulfate and sodium hyaluronate
* Drug: Hyaluronan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: presenting with uni or bilateral medial and/or lateral femorotibial osteoarthritis of the knee evolving for more than 6 months patients taking analgesic medications for at least 3 months prior to randomisation and dissatisfied with their current therapy Exclusion Criteria: isolated symptomatic femoropatellar osteoarthritis target knee prothesis having undergone an articular lavage, or an arthroscopy or any surgery on the target knee in the 6 months preceding randomisation, target knee osteoarthritis with clinical joint effusion at selection and at randomization body mass index (BMI) greater than or equal to 30, patient having received any corticosteroid treatment by any administration route (other than inhalers, ocular, auricular route) in the month preceding randomisation, patient having received intra-articular steroid injection in the target knee within the month preceding randomisation or patient having received intra-articular hyaluronic acid in the target knee in the 6 months preceding randomisation

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: V0220<br> | Device: Chondroitin sulfate and sodium hyaluronate<br>* 3 weekly injections<br>|
| Active Comparator: Hyaluronan<br> | Drug: Hyaluronan<br>* 3 weekly injections<br>* Other names: Hyalgan®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain relief assessed on a global pain Visual Analogic Scale |  | change from baseline over 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional improvement (questionnaire) |  | change from baseline over 24 weeks | 
| Patient's and investigator's global assessment of the disease status (Visual Analogic Scale ) |  | change from baseline over 24 weeks | 
| Patient's health related quality of life (questionnaire) |  | over 24 weeks | 
| Consumption of analgesic medication (paracetamol and NSAIDs)(number of days and quantity) |  | over 24 weeks | 
| Medico-economic questionnaire |  | over 24 weeks | 
| Occurrence of adverse events |  | over 24 weeks |