Efficacy and Safety Study of Glucosamine/Chondroitin Sulfate to Patients Treatment With Osteoarthrosis of the Knee

Study Overview
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Brief Summary
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The purpose of this study is to assess the efficacy and safety of glucosamine and chondroitin sulfate association in the treatment of patients with osteoarthrosis of the knee.

Detailed Description
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To assess the efficacy and safety of the association of glucosamine sulphate 500 mg/chondroitin sulphate 400 mg (Eurofarma) in the treatment of osteoarthritis, compared to Cosamin DS® (Nutramax) in same presentation and pharmaceutical form. Some eligibility criteria: Osteoarthritis of the knee confirmed by radiological examination; Visual analogue scale (VAS) > 40 mm; Clinical diagnosis of pain and functional limitation

Official Title
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A Multi-center, Randomized, Double Blind, Comparative of Efficacy and Safety From Association of Capsules Glucosamine and Chondroitin Sulfate (Eurofarma) Versus Cosamin DS to Treatment With Osteoarthrosis of the Knee

Conditions
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Osteoarthritis of the Knee

Intervention / Treatment
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* Drug: Glucosamine sulphate and chondroitin sulphate association
* Drug: Cosamin DS® (Nutramax)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects have to read and sign the approved the Informed Consent form prior to any participation in the study. Male or female Subjects, aged upper to 40 years. Osteoarthritis of the knee confirmed by radiological examination. Visual analogue scale (VAS) > 40 mm. Kellgren and Lawrence grade 1 to 3. Clinical diagnosis of pain and functional limitation. Exclusion Criteria: History of significant trauma or surgery in the affected joint. Pregnant women, lactating or not using appropriate contraceptive method. History or presence of active rheumatic disease that may be responsible for secondary osteoarthritis. Severe inflammation of the joint confirmed by physical examination (excluding also erythrocyte sedimentation <40mm/h and rheumatoid factor <1:40). Body mass index > 30. Hematologic abnormalities, liver, renal or metabolic functions which undermine the serious participation of the patient (at investigator's criteria). Systemic administration and/or intra-articular corticosteroids in the last 3 months. Have made use of glucosamine and/or chondroitin. Lequesne index of > 12. Arthroplasty in the affected joint. Use of narcotic analgesics. Any condition that, in the opinion of the investigator, renders the patient unable to participate in the study.

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cosamin DS®<br>glucosamine hydrochloride 500 mg and chondroitin sulfate 400 mg (Cosamin DS®, Nutramax Laboratories). The medication was supplied as capsules, with the daily dose of 3 capsules. | Drug: Cosamin DS® (Nutramax)<br>* oral capsule of glucosamine hydrochloride 500 mg + chondroitin sulphate 400 mg thrice daily before meals. Period: 127 days<br>* Other names: glucosamine hydrochloride and chondroitin sulphate;|
| Experimental: Glucosamine/ chondroitin sulphate<br>Glucosamine hydrochloride 500 mg and chondroitin sulphate 400 mg association (Eurofarma) T.I.D. before each meal The medication was supplied as capsules, with the daily dose of 3 capsules. | Drug: Glucosamine sulphate and chondroitin sulphate association<br>* glucosamine sulphate 500 mg and chondroitin sulphate 400 mg association T.I.D. before each meal<br>* Other names: Glucosamine sulphate and Chondroitin sulphate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Assess the Efficacy and Safety of the Association of Glucosamine Sulphate 500 mg/Chondroitin Sulphate 400 mg (Eurofarma) in the Treatment of Osteoarthritis, Compared to Cosamin DS® (Nutramax)in Same Presentation and Pharmaceutical Form | To assess the efficacy and safety of the association of glucosamine sulphate 500 mg/chondroitin sulphate 400 mg (Eurofarma) in the treatment of osteoarthritis, compared to Cosamin DS® (Nutramax) in same presentation and pharmaceutical form. | approximately 5 months | 

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