Effectiveness of Glucosamine + Chondroitin in Osteoarthrosis - Full Text View

Sponsored by:	L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
Information provided by:	L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier:	NCT00860873

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Dietary Supplements Diets Osteoarthritis

Drug Information available for: Glucosamine hydrochloride Translagen Glucosamine sulfate Glucosamine Chondroitin Chondroitin sulfates

U.S. FDA Resources

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 ]

Estimated Enrollment:	280
Study Start Date:	May 2009
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

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

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

Contacts

Contact: alexandre frederico, doctor

55 19 3829-3822

dr.alexandre@alclinica.com.br

Locations

Brazil, Sao Paulo
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:	LAL Clinica ( Alexandre Frederico )
Study ID Numbers:	CGSEMS1108
Study First Received:	November 26, 2008
Last Updated:	March 11, 2009
ClinicalTrials.gov Identifier:	NCT00860873 History of Changes
Health Authority:	Brazil: National Health Surveillance Agency

Study placed in the following topic categories:

Chondroitin
Musculoskeletal Diseases
Osteoarthritis
Glucosamine

Arthritis
Joint Diseases
Rheumatic Diseases

Additional relevant MeSH terms:

Musculoskeletal Diseases
Osteoarthritis
Arthritis
Joint Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 10, 2009