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

Phase 3 Completed 100 enrolled Eurofarma Laboratorios S.A.

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start: 2010-08
Primary completion: 2011-02
Completion: 2011-06

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

paper the lower limit of the 90% confidence interval (CI) between the two groups (- 8.39%) was higher than the established margin of non-inferiority of - 10.00%. PMID 30657100 ↗

Publications

Lomonte ABV, Mendonca JA, de Castro Brandao G, Castro ML. Multicenter, randomized, double-blind clinical trial to evaluate efficacy and safety of combined glucosamine sulfate and chondroitin sulfate capsules for treating knee osteoarthritis. Adv Rheumatol. 2018 Dec 5;58(1):41. doi: 10.1186/s42358-018-0041-9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Chondroitin	Unknown	400 mg	Oral
Subject	Glucosamine	Small molecule	500 mg	Oral