E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
acute gastroenteritis in children. |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10017893 |
E.1.2 | Term | Gastroenteritis astroviral |
|
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 |
1. Evaluate on an appropriate number of patients the effectiveness of an enterovaccine (Colifagina) administered by mouth and associated to an oral/intravenous rehydration therapy based on polyelettrolitical solutions, in relation to the clinical outcome of the children suffering from acute gastroenteritis. |
|
E.2.2 | Secondary objectives of the trial |
2. Evaluate, in this area of interest, the etiologic role of the Astrovirus and of the possible co-infections with Rotavirus and faecal Adenovirus. 3. Evaluate if the treatment with Colifagina determines an increase in the production of intestinal secretory IgA and if it may be correlated to a better clinical outcome |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients aged >2 and <10 years old Intestine symptoms have been present for at least 24 hours and for less than 3 weeks: diarrhoea (al least 2 evacuations/day) and/or vomit. Fever (TC = o > 37.5C). Informed consent to study given by parents |
|
E.4 | Principal exclusion criteria |
Patients suffering from a present or past neoplastic condition, with chronic renal insufficiency and/or hepatic insufficiency or severe cardiovascular and/or neurological and/or gastrointestinal pathology. Patients with congenital deficit of IgA and/or with congenital immuno-deficiency Patients receiving immunosuppressive therapy |
|
E.5 End points |
E.5.1 | Primary end point(s) |
- Primary End-point: clinical outcome, based on the number of:  inpatient hospital stays  clinical evaluation of the symptoms expressed in VAS (general conditions, hydration status, presence/absence of vomit, presence/absence of abdominal distension, presence/absence of oral feeding, regained hydration by mouth, fever) and of the signs (decrease of the number of evacuations/day; aspect of the stools evaluated according to the Bristol stool scale) in the two treated groups |
|
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 | Yes |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
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 | Yes |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
terapia reidratatnte elettrolitica |
|
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
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 | 7 |
E.8.9.1 | In the Member State concerned days | |
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 | 7 |