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

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

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.