Title
Efficacy and Safety Study of Glucosamine/Chondroitin Sulfate to Patients Treatment With Osteoarthrosis of the Knee
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
Phase
Phase 3Lead Sponsor
Eurofarma Laboratorios S.A.Study Type
InterventionalStatus
Completed Results PostedIndication/Condition
Osteoarthritis of the KneeIntervention/Treatment
chondroitin glucosamine ...Study Participants
100The 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.
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
glucosamine sulphate 500 mg and chondroitin sulphate 400 mg association T.I.D. before each meal
oral capsule of glucosamine hydrochloride 500 mg + chondroitin sulphate 400 mg thrice daily before meals. Period: 127 days
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.
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.
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.
| Event Type | Organ System | Event Term | Cosamin DS® | Glucosamine/Chondroitin Sulphate |
|---|
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.
