196
Participants
Start Date
August 17, 2015
Primary Completion Date
May 10, 2017
Study Completion Date
May 10, 2017
Febuxostat 80/120mg/day
Starting dose and dose regimen of Febuxostat : the initial daily dose is 80 mg. In case the patient has the serum urate concentration \> 6 mg/dl after 2 weeks of treatment the dose will be escalated to 120 mg and if tolerated will be maintained for the duration of the study.
Allopurinol 100 up to 600mg/day
Starting dose and dose regimen of allopurinol : the initial daily allopurinol dose is 100 mg, to be increased by 100 mg every 2 weeks in patients with serum urate concentration \>6 mg/dl. The maximum daily dose of allopurinol achievable in the study will depend on kidney function and tolerability, but will not exceed 600 mg.
Colchicine
Colchicine 0.5 mg tablets.To prevent flares in the initial stages of treatment, patients will be treated for at least 6 months with colchicine 0.5 - 1 mg QD
Naproxen
Naproxen sodium 550 mg film coated tablets. In case of colchicine intolerance patients will be treated for at least 6 months with Naproxen 550 mg BID and Omeprazole (20-40 mg once daily), if indicated to be used.
Omeprazole
Omeprazole 20 mg capsules, co-administered to patients for gastric protection.
Reade Clinic, Amsterdam
Azienda Ospedaliero-Universitaria Policlinico Sant'Orsola-Malpighi, Bologna
"Ospedale Policlinico SS. Annunziata Università degli Studi G. d'Annunzio. Dipartimento di Medicina e Scienze dell'Invecchiamento.", Chieti
Presidio Ospedaliero San Filippo e Nicola Università degli Studi dell'Aquila U.O.C Geriatria e Lungodegenza Geriatrica, Avezzano
Ospedale San Salvatore U.O.C. Medicina Interna e Nefrologia Dipartimento MeSVA Università degli Studi dell'Aquila, Coppito
"Medizinische Klinik und Poliklinik III/Rheumatologie Universitätsklinikum Carl Gustav Carus Der Technischen Universität", Dresden
Gdańskie Centrum Zdrowia Sp.z o.o., Gdansk
Specjalistyczna Praktyka Lekarska Piotr Kubalski, Grudziądz
Centrum Medyczne Pratia Katowice, Katowice
Centrum Medyczne Plejady, Krakow
Krakowski Szpital Specjalistyczny im. Jana Pawła II w Krakowie, Krakow
Specjalistyczny Gabinet Dermatologiczno-Kosmetyczny, Krakow
Oddział Kardiologiczny, WSS im. W. Biegańskiego w Łodzi, Lodz
Polimedica, Lodz
Pratia S,A, Warsaw
Reumatika- Centrum Reumatologii, Warsaw
S.C. Centrul Medical Sana S.R.L., Bucharest
S.C. Cardiomed S.R.L., Craiova
Cabinet Medical Medicina Interna, Timișoara
Institutul de Boli Cardiovasculare Clinica de Cardiologie si Recuperare Cardiovasculara, Timișoara
Institut za kardiovaskularne bolesti Dedinje, Belgrade
Institut za reumatologiju, Belgrade
"Kliničko-bolnički centar Bežanijska kosa Klinika za imunologiju i alergologiju", Belgrade
Vojnomedicinska akademija Klinika za reumatologiju, Belgrade
Clinica Medicală Data Plus SRL, Bucharest
Institutul Clinic Fundeni, Bucharest
Menarini International Operations Luxembourg SA
INDUSTRY