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

• Status: Unknown status
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eurofarma Laboratorios S.A.

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.