NCT02409381

Extract of Curcuma Longa Complexed With Phosphatidilcholine(Motore®)in the Treatment of Adults With Knee Osteoarthritis

Clinical Trial, Multicenter, Phase IV, Open, Randomized, Parallel, Controlled, Non-inferiority, to Evaluate the Efficacy and Safety of Motore® Compared to Alivium® in the Treatment of Adults With Knee Osteoarthritis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 288 (actual)
• Sponsor: Ache Laboratorios Farmaceuticos S.A. · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Prospective, multicenter, phase IV, open, randomized, parallel, controlled, in which 288 (two hundred and eighty-eight) participants of both sexes, aged between 40 and 75 years will be randomly allocated to one of two treatment groups , and treatment group 01 will be the dried extract of Curcuma longa complexed with phosphatidylcholine (Motore®), and treatment group 02 will ibuprofen (Alivium®).

Detailed description

This study evaluate the efficacy and safety of Dry Extract of Curcuma Longa complexed with phosphatidilcholine (Motore®) Compared to Ibuprofen (Alivium® ) in the treatment of adults with knee osteoarthritis. The study population will consist in participants of both sexes, aged between 40 and 80 years old with a clinical diagnosis of knee osteoarthritis (tibiofemoral joint) based on clinical and radiological criteria (Grades 2 and 3 Kellgren and Lawrence) and who had osteoarthritis symptoms in the last six (06) months preceding the start of the study. They will be randomly allocated to one of two treatment groups , and treatment group 01 will be the dried extract of Curcuma longa complexed with phosphatidylcholine (Motore®), and treatment group 02 will ibuprofen (Alivium®).

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DRUG	Motore	250 mg
DRUG	Alivium	600 mg

Timeline

• Start date: 2015-06-01
• Primary completion: 2016-05-01
• Completion: 2016-06-01
• First posted: 2015-04-06
• Last updated: 2016-08-25

Locations

1 site across 1 country: Brazil