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) Male Female Patients |
| 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 |
| Notice | |
| 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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