Status:
COMPLETED
Effectiveness of Glucosamine + Chondroitin in Osteoarthrosis
Lead Sponsor:
Azidus Brasil
Conditions:
Osteoarthrosis
Eligibility:
All Genders
30-80 years
Phase:
PHASE3
Brief Summary
This study objective is to check the non-inferiority of the 2 formulations produced by EMS when compared with the same substances and pharmaceuticals forms of the product Condroflex (Zodiac), by promo...
Eligibility Criteria
Inclusion
- Patients who agree with all aspects of the study and sign the Informed Consent;
- Patients of both sexes;
- Age above 30 years;
- Clinical and radiological diagnosis of osteoarthritis;
- Osteoarthritis in grades 1-2;
- Patients who are conducting medical treatment and that, for trial of Investigator, is eligible for the study.
Exclusion
- Patients with a history of trauma clinically significant;
- Patients who underwent surgery on joints affected;
- Coexistence of diseases that might impede the successful conclusion of the trial (rheumatism and others);
- Pregnant patients and / or breastfeeding;
- Patients with phenylketonuria;
- Patients with clinical diagnosis of severe renal failure;
- Patients with clinical diagnosis of severe liver disease;
- Patients with clinical diagnosis of clotting disorders;
- Patients who are being treated with anti-aggregating and / or anticoagulants;
- Patients with sensitive components of the formula;
- Patients with emotional disorders that interfere with the capture of data;
- Patients who do not agree with the purposes of the study and did not sign the Informed Consent.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT00860873
Start Date
October 1 2009
End Date
November 1 2010
Last Update
February 25 2013
Active Locations (1)
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1
Lal Clinica Pesquisa E Desenvolvimento Ltda
Valinhos, São Paulo, Brazil, 13270000