Studiul urmareste evaluarea eficacitatii, sigurantei, tolerabilitatii administrarii de fasinumab la pacientii cu gonartroza sau coxartroza comparativ cu placebo sau naproxen. Evaluarea s-a facut atat dupa 16 saptamanii de administrare, dar si dupa 52 de saptamani.

Titlu Studiu

A Phase 3 Randomized, Double-blind, Multi-dose, Placebo and Naproxen-Controlled Study to Evaluate the Efficacy and Safety of Fasinumab in Patients With Pain Due to Osteoarthritis of the Knee or Hip

Cod protocol: FACT OA1

Numar EudraCT: 2016-005020-29

Sponsor: Regeneron Pharmaceuticals

Medicament de investigatie clinica: fasinumab

Medicament de investigatie clinica comparator: naproxen

Placebo: da

International/National: international

Faza: III

Centre România

Clinica Medicala Synexus Ltd., Bucharest, Romania, 021611

SC Policlinica CCBR SRL, Bucharest, Romania, 030463