E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Infectious enteritis with vomiting |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10058839 |
E.1.2 | Term | Enteritis infectious |
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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 |
Is it possible to reduce dehydration due to vomiting in the initial phase of enteritis with vomiting with Dimenhydrinate suppositories (weight adapted dosage) in comparison to placebo in children. Better rehydration is measured by weight gain in between visit 1 and 2 (visit 2 is 18-24 hours after visit 1) |
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E.2.2 | Secondary objectives of the trial |
Can the number of vomiting episodes between visit 1 and 2 be reduced by dimenhydrinat vs. placebo? Is there a reduction in the number of necessary hospitalisations due to infectious enteritis and vomiting in the study population? Is the condition of the child estimated by their caregivers (measured in a visual scale) improved. Furthermore adverse events and adverse drug reactions will be documented. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Acute vomiting started 8-24 hours prior the inclusion due to suggested infectious enteritis with at least 2 episodes of vomiting in the last 12 hours age: 6 months - 5 years weight over 7000g outpatients informed consent of at least one caregiver |
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E.4 | Principal exclusion criteria |
Contraindications against the study drug receipts of the following medications: Treatment with medicinal products with suspected interactions with dimenhydrinat, Treatment with antiemetics or secretion inhibitors severe disease with one of the following criteria: bloody stool (with this disease) suggested requirement of i.v. rehydration Confirmed weight loss of more than 5% body weight Metabolic acidosis (i.e. pH < 7,25) and/or electrolyte disturbances (measured by blood test in the emergency clinic originated in the responsibility of the investigator) Suspected lack of cooperation and compliance by the patient or the caregiver(s) or linguistic problems of the parents Participation in other medical trials |
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E.5 End points |
E.5.1 | Primary end point(s) |
Relative weight gain from visit 1 to visit 2 (measured as quartile of the weight at visit 1 in stratified rank). Worst rank will be hospitalization. |
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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 | Yes |
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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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 | Yes |
E.8.2.3 | Other | No |
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 | 12 |
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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |