E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
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 compare the percentage of the children who revisit the physician during the same episode of vomiting. |
Comparar el porcentaje de niños participantes que re-acuden al médico/pediatra por el mismo episodio. |
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E.2.2 | Secondary objectives of the trial |
1. To compare the percentage of children who vomit during 8, 24 and 48 hours after the first dose of ondansetron has been taken. 2. To compare the number of vomits provided by the parents after the first dose of ondansetron has been taken. 3. To compare the duration of the vomits in each group. 4. To compare the percentage of the children who exhibit diarrhea in each group. 5. To compare the percentage of children who present adverse effects in each group. 6. To compare the results of the children who visit a physician in the Primary Care Center due to the same episode. 7. To compare the results of the children who visit a physician in the Hospital Emergency Area due to the same episode. 8. To compare the percentage of children who need intravenous rehydration. 9. To compare the percentage of children who need hospitalization during the same period. 10. To compare satisfaction of the parents during the treatment. |
1. Comparar el porcentaje de niños que presentan vómitos a las 8, 24 y 48 horas tras la administración de la primera dosis.
2. Comparar el número de vómitos referidos por los padres tras la administración de la primera dosis.
3. Comparar la duración de los vómitos en cada grupo.
4.Comparar el porcentaje de pacientes que presentan diarrea en cada grupo.
5. Comparar el porcentaje de niños que presentan efectos adversos en cada grupo.
6. Comparar el porcentaje de niños participantes que acuden a consulta médica/pediátrica de atención primaria por el mismo episodio.
7. Comparar el porcentaje de niños participantes que acuden a urgencias pediátricas por el mismo episodio.
8. Comparar el porcentaje de niños que requieren rehidratación intravenosa.
9. Comparar el porcentaje de niños que requieren ingreso debido a ese episodio.
10. Comparar el grado de satisfacción de los padres con el tratamiento. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Presence of two vomits during the last 4 h - Failed oral rehydration tolerance - Informed consent signature by the parents or legal guardian - Vomits or acute gastroenteritis with vomits diagnosis -Pacients with weight higher or equal to 15 Kg |
- Presencia de al menos 2 vómitos en las últimas 4 horas - Prueba de tolerancia negativa - Firma del consentimiento informado por parte de los padres o tutores legales. - Diagnóstico de vómitos o diagnóstico de gastroenteritis agudo con vómitos - Pcientes de peso mayor o igual a 15 Kg |
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E.4 | Principal exclusion criteria |
- Consciousness alteration. - Acute abdomen suspicion (appendicitis…). - Obstruction symptoms suspicion. - Previous known digestive illnesses (Chron disease…) - Food poisoning suspicion. - Previous known pharmacy allergy. - Severe grade of dehydration. - Bilious vomiting. - Previous abdominal surgery. - Previous illness who will affect the patient hydration. - Hospitalization or intravenous rehydration is need. |
- Alteración de la conciencia - Sospecha de abdomen agudo (apendicitis, invaginaciones…) - Sospecha o presencia de cuadros obstructivos - Enfermedad digestiva grave conocida (Enfermedad de Crohn, colitis ulcerosa,…) - Sospecha de intoxicación alimentaria - Alergia a cualquiera de los fármacos utilizados en el estudio - Deshidratación severa (ver tabla clasificación deshidratación) - Vómitos biliosos - Cirugía abdominal previa - Patología que pueda afectar a grado de hidratación del paciente (fallo renal, hipoalbuminemia…) - Requerimiento de ingreso o rehidratación intravenosa por cualquier motivo |
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E.5 End points |
E.5.1 | Primary end point(s) |
Re-visits the physician during the same episode of vomiting. |
Repetición de visitas al médico/pediatra por el mismo episodio. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Within 24, 48 hours and 7 days after de emrgency visit. |
24, 48 horas y 7 días tras el alta de urgencias. |
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E.5.2 | Secondary end point(s) |
Vomiting. Sickneess/nausea. Visits anda hospitalization. Intravenous rehydration. Adverse effects. parents satisfaction with the treatment. |
Vómitos. Nauseas. Consultas e ingresos. Rehidratación intravenosa. Efectos adversos. Satisfacción de los padres con el tratamiento. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Within 8, 24 , 48 hours anda 7 days after de emrgency visit. |
8, 24, 48 horas y 7 días tras el alta de urgencias. |
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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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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 |
Standard Clinical Practice |
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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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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 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |