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

Launched by EUROFARMA LABORATORIOS S.A. · Aug 7, 2009

Keywords

ClinConnect Summary

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

Gender

ALL

Eligibility criteria

• 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.