E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated | Crohn's Disease | Morbo di Crohn | |
E.1.1.1 | Medical condition in easily understood language | Crohn's Disease | Morbo di Crohn | |
E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 | E.1.2 | Level | PT | E.1.2 | Classification code | 10011401 | E.1.2 | Term | Crohn's disease | E.1.2 | System Organ Class | 10017947 - Gastrointestinal disorders | |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial | to investigate the safety of Entocort (budesonide) in a Paediatric population treated for mild to moderate Crohn's disease | Valutare la sicurezza di Entocort™ EC (budesonide) in una popolazione pediatrica trattata per il morbo di Crohn in forma lieve o moderata | |
E.2.2 | Secondary objectives of the trial | To characterize the disease activity in the trial population before and after treatment through the paediatric Crohn's Disease Activity Index (PCDAI); Patient reported outcomes: Quality of Life with Entocort EC treatment based on a subject questionnaire (IMPACT 3) | -Caratterizzare l’attività della malattia nella popolazione in studio attraverso l’indice pediatrico di attività del morbo di Crohn (PCDAI). -Valutare la qualità di vita attraverso un questionario compilato dai pazienti (IMPACT 3). | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria | 1.All male and female subjects must be aged 5 to 17, inclusive, and must not have reached their 18th birthday by the estimated final office visit 2.Subject must be diagnosed with active Crohn's disease of the ileum and/or ascending colon confirmed by endoscopic and/or radiographic evidence, and/or evidence of mucosal erosions and/or histology within the last year 3.Subjects with mild to moderate Crohn's disease 4.All subjects must have a stool analysis negative for Clostridium difficile, Yersinia enterolytica, Campylobacter jejuni, Salmonella, Shigella, within the 30 days prior to visit 1 5.Alls subjects must have had laboratory assessments within 7 days prior to visit 1 | 1Tutti i soggetti di sesso maschile e femminile devono avere età compresa o uguale tra 5 e 17 anni e non dovranno avere compiuto il loro 18 ° compleanno entro la data in cui è prevista la visita finale. 2Diagnosi del morbo di Crohn dell’ileo e/o del colon ascendente in fase attiva confermata da prove endoscopiche e / o esami radiografici, e/o evidenza di erosioni della mucosa e/o istologia effettuata nel corso dell'ultimo anno. 3Soggetti affetti dal morbo di Crohn in forma lieve o moderata, che necessiterebbero di un trattamento con Entocort ™ CE (ad esempio, in linea con l'indicazione per il trattamento della malattia di Crohn in forma lieve o moderata dell’ ileo e/o del colon ascendente negli adulti). 4Analisi negative, per Clostridium difficile, enterolytica Yersinia, Campylobacter jejuni, Salmonella, Shigella, entro i 30 giorni prima della Visita 1. 5Ottenimento delle valutazioni di laboratorio entro 7 giorni prima della Visita 1. | |
E.4 | Principal exclusion criteria | 1.Subjects who have had any previous intestinal resection proximal to and including the ascending colon 2.Subjects with evidence of severe active Crohn's Disease and/or, structuring and prestenotic dilatation, clinical evidence of obstruction, perirectal abscess, perirectal disease with active draining fistulas, perforation, or any septic complications 3.Subjects who do not have a negative stool analysis, within the 30 days prior to Visit 1 4.Subjects who have been screened/or enrolled in this study previously within the last 6 months | 1.Soggetti che hanno avuto una precedente resezione intestinale prossimale compreso il colon ascendente. 2.Soggetti con evidenza del morbo di Crohn severo attivo e / o, dilatazione stenosante e prestenotica o evidenza clinica di ostruzione, ascessi perirettali, malattia perirettale con fistole drenanti attive, perforazione, o complicanze settiche. 3.Soggetti che non presentano analisi negativa delle feci per Clostridium difficile, enterolytica Yersinia, Campylobacter jejuni, Salmonella, Shigella, entro i 30 giorni prima della Visita 1. 4.Soggetti che sono stati precedentemente screenati o arruolati in questo studio negli ultimi 6 mesi. | |
E.5 End points |
E.5.1 | Primary end point(s) | Safety measures such as adverse events, GCS-related side effects, HPAaxis measurement, laboratory test results and vital signs will be listed and summarized descriptively, with summaries including all subjects who received at least one dose of study treatment. Summaries will be produced by all patients and by dose group (6 mg or 9 mg). | Safety measures such as adverse events, GCS-related side effects, HPAaxis measurement, laboratory test results and vital signs will be listed and summarized descriptively, with summaries including all subjects who received at least one dose of study treatment. Summaries will be produced by all patients and by dose group (6 mg or 9 mg). | |
E.5.1.1 | Timepoint(s) of evaluation of this end point | end of 8 week treatment period | al termine delle 8 settimane di trattamento | |
E.5.2 | Secondary end point(s) | |
E.5.2.1 | Timepoint(s) of evaluation of this end point | |
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 | The trial involves single site in the Member State concerned | No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 13 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned | |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 | Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial | |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 22 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 26 |
E.8.9.2 | In all countries concerned by the trial days | 0 |