Osteoarthrosis Clinical Trial
Official title:
Randomized Study of Two Dosage Forms (Oral Powder and Capsule) of "Chondroitin + Glucosamine Sulfate" Produced by the Laboratory EMS When Compared to the Product Condroflex (Oral Powder and Capsules) Produced by Laboratory Zodiac in the Treatment of Osteoarthrosis.
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 promoting the relief of osteoarthrosis symptoms such as pain, stiffness and functional capacity that will be periodically measured by using the "Visual Analog Scale" of pain (VAS) and the questionnaire of Lequesne.
Status | Completed |
Enrollment | 280 |
Est. completion date | November 2010 |
Est. primary completion date | November 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 30 Years to 80 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Lal Clinica Pesquisa E Desenvolvimento Ltda | Valinhos | Sao Paulo |
Lead Sponsor | Collaborator |
---|---|
L.A.L Clinica Pesquisa e Desenvolvimento Ltda. |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Decrease in pain. | V0 (Screening); V1 (Inclusion); V2 (2 weeks); V3 (4 weeks); V4 (8 weeks); V5 (12 weeks); V6 (24 weeks). | No |
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