E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
acute gastroenteritis |
Akute Gastroenteritis |
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E.1.1.1 | Medical condition in easily understood language |
gastric flu |
Magen-Darm Grippe |
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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 | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10017784 |
E.1.2 | Term | Gastric flu |
E.1.2 | System Organ Class | 100000004862 |
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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 |
The primary objective of this clinical trial is to investigate whether Lytomed® finds greater acceptance among children of 1-13 years compared to Normolyt®. |
Primäres Ziel dieser klinischen Prüfung ist, zu untersuchen, ob Lytomed® im Vergleich zu Normolyt® eine höhere Akzeptanz bei Kindern von 1-13 Jahren findet. |
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E.2.2 | Secondary objectives of the trial |
Alterations of base excess Change of the duration of the hospitalisation Alterations of body weight Change of compliance |
Veränderungen des Base Excess Veränderungen der stationären Aufenthaltsdauer Veränderungen des Körpergewichts Veränderung der Compliance |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Hospitalisation due to acute gastroenteritis • Written informed consent of the parents of the participating child and the child's informed consent • Age: 1-13 years • necessity of receiving an oral rehydration preparation |
• Stationärer Aufenthalt aufgrund akuter Gastroenteritis • Schriftliche Einverständniserklärung der Eltern des teilnehmenden Kindes sowie Einwilligung des Kindes nach erfolgter Aufklärung • Alter: 1-13 Jahren • Notwendigkeit der Gabe eines oralen Rehydrations-Präparates
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E.4 | Principal exclusion criteria |
• Parenteral rehydration • A history of hypersensitivity to any of the active substances or ingredients used • Diabetes mellitus • kidney diseases • reduction in blood acidity • persistent vomiting • disturbances of consciousness and unconsciousness • Metabolic alkalosis • anuria • monosaccharide malabsorption • Shock •Pregnancy |
• Parenterale Rehydration • Anamnestisch bekannte Überempfindlichkeit gegenüber einem der eingesetzten Wirk- bzw. Inhaltsstoffen • Diabetes mellitus • Nierenerkrankungen • Verminderung des Blutsäuregrades • Unstillbares Erbrechen • Bewusstseinsstörungen und Bewusstlosigkeit • Metabolische Alkalose • Anurie • Monosaccharid-Malabsorption • Schock • Schwangerschaft |
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E.5 End points |
E.5.1 | Primary end point(s) |
Acceptance of the oral Rehydration solution.
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Akzeptanz der oralen Rehydrationslösung.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
0-maximum 72 hours after first admission |
0-maximal 72 Stunden nach Erstgabe
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E.5.2 | Secondary end point(s) |
base excess duration of the hospitalisation body weight compliance |
Base Excess stationäre Aufenthaltsdauer Körpergewicht Compliance |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
0-maximum 72 hours after first admission
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0-maximal 72 Stunden nach Erstgabe
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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 | No |
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 | Yes |
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 |
Elektrolytlösung mit Glucose |
Glucose-electrolytic solution |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.5 | 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 | No |
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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LVLP |
Letzte Visite des letzten Patienten |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 4 |
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 | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |