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This file contains full details on each clinical trial selectedmulti-state trials have been downloaded full information formember states/countries involved in the trial are included
SummaryEudraCT Number: 2015-005111-32Sponsor's Protocol Code Number: ABO-MELI-15National Competent Authority: Italy - Italian Medicines Agency Clinical Trial Type: EEA CTATrial Status: OngoingDate on which this record was first entered in the EudraCT database: 2016-04-04Link: https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-005111-32/IT/
A. Protocol InformationA.1 Member State Concerned: Italy - Italian Medicines AgencyA.2 EudraCT number: 2015-005111-32A.3 Full title of the trial: Multicenter, Prospective, Comparative, RandomizedControlled Clinical investigation on the performance of Promelaxin® micro-enemas versus oral administration of Macrogol 4000, in the treatment ofchronic constipation in infants aged between 6 and 24 months.A.3 Full title of the trial (it): Indagine Clinica Multicentrica, Prospettica, Comparativa, Randomizzata, Controllata sulla prestazione di Microclismi a Base di Promelaxin® versus Macrogol 4000 per Via Orale nel Trattamento della StipsiCronica Funzionale in Lattanti di Età Compresa tra i 6 e i 24 Mesi.A.3.1 Title of the trial for lay people, in easily understood, i.e. non-technical, language: Multicenter, Prospective, Comparative, Randomized ControlledClinical investigation on the performance of Promelaxin® micro-enemas versus oral administration of Macrogol 4000, in the treatment of chronic constipationin infants aged between 6 and 24 months.A.3.1 Title of the trial for lay people, in easily understood, i.e. non-technical, language (it): Indagine Clinica Multicentrica, Prospettica, Comparativa, Randomizzata, Controllata sulla prestazione di Microclismi a Base di Promelaxin® versus Macrogol 4000 per Via Orale nel Trattamento della StipsiCronica Funzionale in Lattanti di Età Compresa tra i 6 e i 24 Mesi.A.3.2 Name or abbreviated title of the trial where available: Not availableA.3.2 Name or abbreviated title of the trial where available (it): Non Disponibile