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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00860873
Other study ID # CGSEMS1108
Secondary ID
Status Completed
Phase Phase 3
First received November 26, 2008
Last updated February 22, 2013
Start date October 2009
Est. completion date November 2010

Study information

Verified date February 2013
Source L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
Contact n/a
Is FDA regulated No
Health authority Brazil: National Health Surveillance Agency
Study type Interventional

Clinical Trial 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 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.


Recruitment information / eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
EMS Chondroitin Sulfate + Glucosamine Sulfate (Oral powder)
Chondroitin Sulfate 1200mg Glucosamine Sulfate 1500mg
EMS Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (hard capsules)
Chondroitin Sulfate 1200mg Glucosamine Sulfate 1500mg
Zodiac: Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (Oral powder)
Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg
Zodiac Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (hard capsules)
Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg

Locations

Country Name City State
Brazil Lal Clinica Pesquisa E Desenvolvimento Ltda Valinhos Sao Paulo

Sponsors (1)

Lead Sponsor Collaborator
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.

Country where clinical trial is conducted

Brazil, 

Outcome

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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