Effectiveness of Glucosamine + Chondroitin in Osteoarthrosis
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.
1 other identifier
interventional
280
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2009
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 26, 2008
CompletedFirst Posted
Study publicly available on registry
March 12, 2009
CompletedStudy Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedFebruary 25, 2013
February 1, 2013
1 month
November 26, 2008
February 22, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Decrease in pain.
V0 (Screening); V1 (Inclusion); V2 (2 weeks); V3 (4 weeks); V4 (8 weeks); V5 (12 weeks); V6 (24 weeks).
Study Arms (4)
Test 1
EXPERIMENTALOral Powder EMS
Test 2
EXPERIMENTALHard Capsules EMS
Comparator 1
ACTIVE COMPARATOROral Powder Zodiac
Comparator 2
ACTIVE COMPARATORHard capsules - Zodiac
Interventions
Chondroitin Sulfate 1200mg Glucosamine Sulfate 1500mg
Chondroitin Sulfate 1200mg Glucosamine Sulfate 1500mg
Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg
Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Azidus Brasillead
Study Sites (1)
Lal Clinica Pesquisa E Desenvolvimento Ltda
Valinhos, São Paulo, 13270000, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 26, 2008
First Posted
March 12, 2009
Study Start
October 1, 2009
Primary Completion
November 1, 2009
Study Completion
November 1, 2010
Last Updated
February 25, 2013
Record last verified: 2013-02