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Sponsored by: |
L.A.L Clinica Pesquisa e Desenvolvimento Ltda. |
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Information provided by: | L.A.L Clinica Pesquisa e Desenvolvimento Ltda. |
ClinicalTrials.gov Identifier: | NCT00860873 |
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 |
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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. |
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 |
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Test 1: Experimental
Oral Powder EMS
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Dietary Supplement: EMS Chondroitin Sulfate + Glucosamine Sulfate (Oral powder)
Chondroitin Sulfate 1200mg Glucosamine Sulfate 1500mg
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Test 2: Experimental
Hard Capsules EMS
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Dietary Supplement: EMS Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (hard capsules)
Chondroitin Sulfate 1200mg Glucosamine Sulfate 1500mg
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Comparator 1: Active Comparator
Oral Powder Zodiac
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Dietary Supplement: Zodiac: Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (Oral powder)
Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg
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Comparator 2: Active Comparator
Hard capsules - Zodiac
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Dietary Supplement: Zodiac Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (hard capsules)
Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg
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Ages Eligible for Study: | 30 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: alexandre frederico, doctor | 55 19 3829-3822 | dr.alexandre@alclinica.com.br |
Brazil, Sao Paulo | |
Lal Clinica Pesquisa E Desenvolvimento Ltda | |
Valinhos, Sao Paulo, Brazil, 13270000 |
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 |
Musculoskeletal Diseases Osteoarthritis Arthritis Joint Diseases Rheumatic Diseases |
Musculoskeletal Diseases Osteoarthritis Arthritis Joint Diseases Rheumatic Diseases |