NCT00955552

Efficacy and Safety Study of Glucosamine/Chondroitin Sulfate to Patients Treatment With Osteoarthrosis of the Knee

A Multi-center, Randomized, Double Blind, Comparative of Efficacy and Safety From Association of Capsules Glucosamine and Chondroitin Sulfate (Eurofarma) Versus Cosamin DS to Treatment With Osteoarthrosis of the Knee

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Eurofarma Laboratorios S.A. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the efficacy and safety of glucosamine and chondroitin sulfate association in the treatment of patients with osteoarthrosis of the knee.

Detailed description

To assess the efficacy and safety of the association of glucosamine sulphate 500 mg/chondroitin sulphate 400 mg (Eurofarma) in the treatment of osteoarthritis, compared to Cosamin DS® (Nutramax) in same presentation and pharmaceutical form. Some eligibility criteria: Osteoarthritis of the knee confirmed by radiological examination; Visual analogue scale (VAS) \> 40 mm; Clinical diagnosis of pain and functional limitation

Conditions

• Osteoarthritis of the Knee

Interventions

Type	Name	Description
DRUG	Glucosamine sulphate and chondroitin sulphate association	glucosamine sulphate 500 mg and chondroitin sulphate 400 mg association T.I.D. before each meal
DRUG	Cosamin DS® (Nutramax)	oral capsule of glucosamine hydrochloride 500 mg + chondroitin sulphate 400 mg thrice daily before meals. Period: 127 days

Timeline

• Start date: 2010-08-01
• Primary completion: 2011-02-01
• Completion: 2011-06-01
• First posted: 2009-08-10
• Last updated: 2023-02-08
• Results posted: 2023-02-08

Locations

4 sites across 1 country: Brazil