CompletedNCT00860873Updated Feb 25, 2013

Effectiveness of Glucosamine + Chondroitin in Osteoarthrosis

A Phase 3 interventional study of EMS Chondroitin Sulfate + Glucosamine Sulfate (Oral powder) and EMS Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (hard capsules) in Osteoarthrosis, sponsored by Azidus Brasil. Completed at 1 site in Brazil. Open to participants aged 30 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-02-25.

Sponsored by Azidus Brasil · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 280
Allocation: Randomized
Ages: 30 Years to 80 Years
Sex: All

Study 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.

Conditions studied

Osteoarthrosis

Browse trials for

Osteoarthritis 4,398

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 280 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

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Lead sponsor

Azidus Brasil is the lead sponsor of 78 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 30 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 280 participants (actual)

Study arms

Experimental
Test 1
Oral Powder EMS
Dietary Supplement: EMS Chondroitin Sulfate + Glucosamine Sulfate (Oral powder)
Experimental
Test 2
Hard Capsules EMS
Dietary Supplement: EMS Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (hard capsules)
Active comparator
Comparator 1
Oral Powder Zodiac
Dietary Supplement: Zodiac: Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (Oral powder)
Active comparator
Comparator 2
Hard capsules - Zodiac
Dietary Supplement: Zodiac Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (hard capsules)

Interventions

Dietary supplementEMS Chondroitin Sulfate + Glucosamine Sulfate (Oral powder)
Chondroitin Sulfate 1200mg Glucosamine Sulfate 1500mg
Dietary supplementEMS Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (hard capsules)
Chondroitin Sulfate 1200mg Glucosamine Sulfate 1500mg
Dietary supplementZodiac: Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (Oral powder)
Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg
Dietary supplementZodiac Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (hard capsules)
Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg

What researchers measure

Primary outcomes

Decrease in pain.
Time frame: V0 (Screening); V1 (Inclusion); V2 (2 weeks); V3 (4 weeks); V4 (8 weeks); V5 (12 weeks); V6 (24 weeks).

Study locations

1 site

Lal Clinica Pesquisa E Desenvolvimento Ltda
Valinhos, Sao Paulo 13270000, Brazil

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 25, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00860873
Lead sponsor: Azidus Brasil
First posted: Mar 12, 2009
Start date: Oct 2009
Primary completion: Nov 2009
Completion: Nov 2010
Last update: Feb 25, 2013

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

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Discussion

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