Status:
COMPLETED
Efficacy and Safety Study of Glucosamine/Chondroitin Sulfate to Patients Treatment With Osteoarthrosis of the Knee
Lead Sponsor:
Eurofarma Laboratorios S.A.
Conditions:
Osteoarthritis of the Knee
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief 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.
Detailed Description
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 sa...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00955552
Start Date
August 1 2010
End Date
June 1 2011
Last Update
February 8 2023
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Instituto de Pesquisa Clínica e Assistencia Medica de Campinas
Campinas, São Paulo, Brazil, 13073-350
2
Centro Paulista de Investigacoes Clinicas Ltda
São Paulo, Brazil, 04266-010
3
Centro de Pesquisa Clínica Perdizes
São Paulo, Brazil, 05005-001
4
Instituto de Medicina Avancada
São Paulo, Brazil, 05437-000