Effectiveness of Glucosamine + Chondroitin in Osteoarthrosis

February 22, 2013 updated by: Azidus Brasil

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

280

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Sao Paulo
      • Valinhos, Sao Paulo, Brazil, 13270000
        • LAL Clínica Pesquisa e Desenvolvimento Ltda

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Test 1
Oral Powder EMS
Dietary supplement: EMS Chondroitin Sulfate + Glucosamine Sulfate (Oral powder)
Chondroitin Sulfate 1200mg Glucosamine Sulfate 1500mg
EXPERIMENTAL: Test 2
Hard Capsules EMS
Dietary supplement: EMS Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (hard capsules)
Chondroitin Sulfate 1200mg Glucosamine Sulfate 1500mg
ACTIVE_COMPARATOR: Comparator 1
Oral Powder Zodiac
Dietary supplement: Zodiac: Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (Oral powder)
Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg
ACTIVE_COMPARATOR: Comparator 2
Hard capsules - Zodiac
Dietary supplement: Zodiac Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (hard capsules)
Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azidus Brasil

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (ACTUAL)

November 1, 2009

Study Completion (ACTUAL)

November 1, 2010

Study Registration Dates

First Submitted

November 26, 2008

First Submitted That Met QC Criteria

March 11, 2009

First Posted (ESTIMATE)

March 12, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

February 25, 2013

Last Update Submitted That Met QC Criteria

February 22, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CGSEMS1108

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Osteoarthrosis

Clinical Trials on EMS Chondroitin Sulfate + Glucosamine Sulfate (Oral powder)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kosovo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe