Effectiveness of Glucosamine + Chondroitin in Osteoarthrosis

This study has been completed.
Sponsor:
Information provided by:
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier:
NCT00860873
First received: November 26, 2008
Last updated: February 22, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Osteoarthrosis
Dietary Supplement: EMS Chondroitin Sulfate + Glucosamine Sulfate (Oral powder)
Dietary Supplement: EMS Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (hard capsules)
Dietary Supplement: Zodiac: Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (Oral powder)
Dietary Supplement: Zodiac Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (hard capsules)
Phase 3

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

Resource links provided by NLM:


Further study details as provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:

Primary Outcome Measures:
  • Decrease in pain. [ Time Frame: V0 (Screening); V1 (Inclusion); V2 (2 weeks); V3 (4 weeks); V4 (8 weeks); V5 (12 weeks); V6 (24 weeks). ] [ Designated as safety issue: No ]

Enrollment: 280
Study Start Date: October 2009
Study Completion Date: November 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00860873

Locations
Brazil
Lal Clinica Pesquisa E Desenvolvimento Ltda
Valinhos, Sao Paulo, Brazil, 13270000
Sponsors and Collaborators
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
  More Information

No publications provided

Responsible Party: Alexandre Frederico, LAL Clinica
ClinicalTrials.gov Identifier: NCT00860873     History of Changes
Other Study ID Numbers: CGSEMS1108
Study First Received: November 26, 2008
Last Updated: February 22, 2013
Health Authority: Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Joint Diseases
Osteoarthritis
Musculoskeletal Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 29, 2014