Effectiveness of Glucosamine + Chondroitin in Osteoarthrosis

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00860873
• Other study ID #: CGSEMS1108
• 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

• Joint Diseases
• Osteoarthritis
• Osteoarthrosis

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