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Detail of the clinical trial

Title of the trial Efficacy, safety and tolerability of a bowel cleansing preparation (Eziclen/Izinova?) in paediatric subjects undergoing colonoscopy: a Phase III, multicentre, randomised, comparative study versus Klean-Prep? (PEG-Electrolytes), administered on the day before colonoscopy, investigator-blinded, non-inferiority in adolescents of 12 to 17 years of age (inclusive) > 40 kg.
EudraCT number 2016-002265-60
Protocol number F-FR-58800-003
Sponsor IPSEN PHARMA SAS, 65 Quai Georges Gorse, 92100 Boulogne-Billancourt, France
Indications Internal medicine
Diagnosis Bowel cleanser before colonoscopy
Population in clinical trial Adolescents (12-17 years)
Year of receiving the request to Institute (SÚKL) 2017
Date of approval by Institute (SÚKL) 24.8.2017
Date of approval by EC 28.6.2017
Date of initiation CT in ČR 4.2.2017
Date of ending CT in ČR 15.5.2020
Sites Fakultní nemocnice Královské Vinohrady ,Dětské oddělení, Gastroenterologie,Šrobárova 50,Praha 10,100 34
Všeobecná fakultní nemocnice v Praze ,Klinika dětského a dorostového lékařství, Gastroenterologie,U Nemocnice 2,Praha 2,128 08

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