WHO ICTRP trial

A clinical study on the therapeutic efficacy and safety of Febuxostat and…

EUCTR2012-001858-25-IT · EU Clinical Trials Register · Not Recruiting

Key facts

Trial ID EUCTR2012-001858-25-IT
Public title A clinical study on the therapeutic efficacy and safety of Febuxostat and Allopurinol on serum urate concentration reduction in subjects suffering from hyperuricemia and gout
Scientific title A multicentre randomised, double-blind, parallel group study on the therapeutic efficacy and safety of Febuxostat (taken once daily) and the therapeutic efficacy and safety of Allopurinol on serum urate concentration in subjects suffering from hyperuricemia and gout - GLASS
Primary sponsor MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.
Registry EU Clinical Trials Register
Recruitment status Not Recruiting
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes
Countries Greece;Spain;Bulgaria;Italy
Conditions Subjects suffering from hyperuricemia and gout MedDRA version: 14.1 Level: PT Classification code 10018627 Term: Gout System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 14.1 Level: PT Classification code…
Interventions Trade Name: Adenuric Pharmaceutical Form: Capsule, hard INN or Proposed INN: FEBUXOSTAT CAS Number: 144060-53-7 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 80- Pharmaceutical form of the placebo…
Registration date Nov 1, 2013
Target size 640
Secondary IDs MEIN/11/FEB-GOU/001;2012-001858-25-GR
Registry page clinicaltrialsregister.eu

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