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.

NCT00860873 Phase 3 COMPLETED

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.

Details

Lead sponsor	Azidus Brasil
Phase	Phase 3
Status	COMPLETED
Enrolment	280
Start date	2009-10
Completion	2010-11

Conditions

• Osteoarthrosis

Interventions

• EMS Chondroitin Sulfate + Glucosamine Sulfate (Oral powder)
• EMS Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (hard capsules)
• Zodiac: Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (Oral powder)
• Zodiac Chondroitin Sulfate 1200mg + Glucosamine Sulfate 1500mg (hard capsules)

Primary outcomes

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

Countries

Brazil