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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.
Details
| Lead sponsor | Mantecorp Industria Quimica e Farmaceutica Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | UNKNOWN |
| Enrolment | 250 |
Conditions
- Osteoarthritis, Knee
Interventions
- Glucosamine sulfate + chondroitin sulfate - MANTECORP
- Glucosamine sulfate + chondroitin sulfate - CONDROFLEX
Primary outcomes
- WOMAC Index — 180 days
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is a set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip. - Paracetamol use — 180 days
Another primary outcome measure is the frequency of use of analgesic medication (paracetamol). - Adverse events — 180 days
Adverse events related to the reference and the test drug will be recorded and used as another primary outcome measure.