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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

NCT01172249 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2010-07-29

No results posted yet for this study

Summary

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.

Conditions

  • Osteoarthritis, Knee

Interventions

DRUG

Glucosamine sulfate + chondroitin sulfate - MANTECORP

1 capsule three times daily before meals (glucosamine sulfate 500 mg + sodium chondroitin sulfate 400 mg).

DRUG

Glucosamine sulfate + chondroitin sulfate - CONDROFLEX

1 capsule three times daily before meals (glucosamine sulfate 500 mg + sodium chondroitin sulfate 400 mg).

Sponsors & Collaborators

  • Mantecorp Industria Quimica e Farmaceutica Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01172249 on ClinicalTrials.gov