Osteoarthritis, Knee Clinical Trial
Official title:
Non-inferiority Study of the Glucosamine Sulfate + Chondroitin Sulfate Association Capsule in Comparison to the CONDROFLEX® Product in Osteoarthrosis of the Knee
This is an open, prospective, randomized, controlled, parallel, multicenter, non-inferiority
study in 250 individuals (125 individuals per group), with 204 evaluable patients with
clinical and radiological diagnosis of osteoarthritis of the knee.
Individuals will be randomized to receive during 180 days the test drug(glucosamine sulfate
500 mg + sodium chondroitin sulfate 400 mg - Mantecorp) or the reference medication
(glucosamine sulfate 500 mg + sodium chondroitin sulfate 400 mg - Condroflex®).
Efficacy will be evaluated through the clinical picture, pain visual analog scale, swelling,
stiffness in the joint, consumption of paracetamol and quality of life.
The safety assessment will be done by monitoring the incidence of adverse events and their
relation to the treatment.
This is an open, prospective, randomized, controlled, parallel, multicenter, non-inferiority
study in 250 individuals (125 individuals per group), with 204 evaluable patients with
clinical and radiological diagnosis of osteoarthritis of the knee.
The subjects in this study are immunocompetent men and women, aged between 55 and 80 years,
diagnosed with osteoarthritis of the knee.
The inclusion will be competitive.
Individuals who qualify in the screening period will be randomized to receive during 180
days one of the following regimens below:
- Therapeutic regimen A: one capsule T.I.D. before meals (drug test - glucosamine sulfate
500 mg + sodium chondroitin sulfate 400 mg - Mantecorp)
- Therapeutic regimen B: one capsule T.I.D. before meals (reference medication -
glucosamine sulfate 500 mg + sodium chondroitin sulfate 400 mg - Condroflex®).
Efficacy will be evaluated through the clinical picture, pain visual analog scale, swelling,
stiffness in the joint, consumption of paracetamol and quality of life.
The safety assessment will be done by monitoring the incidence of adverse events and their
relation to the treatment.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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