Evaluation of a New Formulation Useful for the Osteoarthrosis Treatment

Study Overview
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Brief Summary
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Abstract Kondrium, is a pharmaceutical composition for the treatment of osteoarthritis (OA). This study was designed to evaluate the efficacy and safety of kondrium in the treatment of OA of knee. A 3 month, randomized, double-blind, active-controlled, parallel-group study will be carried out. 117 patients with OA of the knee will be randomized to receive 1 intra-articular monthly injection of 5 mL of one of the following: 75 mg/mL of Kondrium, 82.5 mg/mL of Kondriumf or 8 mg/mL of methylprednisolone once a month during 3 months. The primary efficacy variable will be the change from baseline to final assessment in the Western Ontario and McMaster University OA index (WOMAC subscale score for pain), and Lequesne´s functional index.

Detailed Description
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The WOMAC osteoarthritis index is a validated, multidimensional, disease specific, health status measure. It probes clinically important patient relevant symptoms in the areas of pain, stiffness and physical function in patients with hip and/or knee osteoarthritis. It consists of 24 questions in three separated subscales (5 questions on pain subscale, 17 questions on physical function subscales and 2 questions on stiffness subscale), each scored in analog scale from 0 to 10 points (0 representing no pain, 10 representing extreme pain). Each subscale score was weighed 10 points, thus 30 was the maximum punctuation for WOMAC total score. The Lequesne index is a 10-question interview-style survey given to patients with osteoarthritis of the knee. It has 5 questions pertaining to pain or discomfort, 1 question dealing with maximum distance walked, and 4 questions about daily activities. The total questionnaire is scored on a 0 to 24 scale, with lower scores meaning less functional impairment.

Official Title
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Evaluation of a New Formulation Useful for the Osteoarthrosis Treatment

Conditions
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Osteoarthritis

Intervention / Treatment
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* Drug: kondrium
* Drug: kondrium f
* Drug: methyl prednisolone (corticosteroid)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age > 40 years symptomatic evidence of OA in the knee for at least 1 year radiographic evidence of Kellgren and Lawrence grade II to IV OA of the knee no intra-articular injection of corticosteroids within the last 3 months Exclusion Criteria: any history of adverse reaction to the study drugs current pregnancy status uncontrolled hypertension active infection undergone surgery/arthroscopy within three months diagnosis of radiographic OA of Kellgren and Lawrence grade I

Ages Eligible for Study
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Minimum Age: 40 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: kondrium<br>intraarticular injections once month | Drug: kondrium<br>* intraarticular injections once month<br>|
| Experimental: kondrium f<br> | Drug: kondrium f<br>* intraarticular injections once month<br>|
| Active Comparator: corticosteroid<br>intraarticular injections once month | Drug: methyl prednisolone (corticosteroid)<br>* intraarticular injections once month<br>* Other names: corticosteroid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary efficacy variable is the change from baseline to final assessment in the Western Ontario and McMastern University OA index (WOMAC), and Lequesne´s functional index. |  | 4 months | 

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