Clinical Trials Register

Summary
EudraCT Number:	2016-002601-19
Sponsor's Protocol Code Number:	OND-URG
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2017-02-10
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2016-002601-19

A.3

Full title of the trial

Effectiviness and safety of the administration of ondansetron versus placebo for the treatment of vomit in children with mild and moderate dehydration: randomized clinical trial

Eficacia y seguridad de la administración de ondansetron frente a placebo para el tratamiento de los vómitos en niños con deshidratación leve-moderada: Ensayo clínico aleatorio

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

ondansetron for dehydratation in children

ondansetron para el tratamiento de la deshidratacion en niños

A.3.2

Name or abbreviated title of the trial where available

Ondansetron en urgencias

A.4.1

Sponsor's protocol code number

OND-URG

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Basque Health Service
B.1.3.4	Country	Spain
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Basque Health Service
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Basque Health Service
B.5.2	Functional name of contact point	Lizar Aguirre
B.5.3	Address:
B.5.3.1	Street Address	c/ Jose Atxotegui s/n
B.5.3.2	Town/ city	Vitoria-Gasteiz
B.5.3.3	Post code	01009
B.5.3.4	Country	Spain
B.5.4	Telephone number	34945007248
B.5.5	Fax number	34945007248
B.5.6	E-mail	LIZAR.AGUIRREPASCASIO@osakidetza.net

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Ondansetron Normon
D.2.1.1.2	Name of the Marketing Authorisation holder	Laboratorios NORMON S.A.
D.2.1.2	Country which granted the Marketing Authorisation	Spain
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Ondansetron
D.3.9.1	CAS number	99614-02-5
D.3.9.3	Other descriptive name	ONDANSETRON HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB03517MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	4
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Ondansetron Normon
D.2.1.1.2	Name of the Marketing Authorisation holder	Laboratorios NORMON S.A.
D.2.1.2	Country which granted the Marketing Authorisation	Spain
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Ondansetron
D.3.9.1	CAS number	99614-02-5
D.3.9.3	Other descriptive name	ONDANSETRON HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB03517MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	8
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Vomiting

Vómitos

E.1.1.1

Medical condition in easily understood language

Vomiting

Vómitos

E.1.1.2

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

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.

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.

E.2.3

Trial contains a sub-study

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

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

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.

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.

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.

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.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

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

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Standard Clinical Practice

E.8.2.4

Number of treatment arms in the trial

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

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

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

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

Yes

F.1.1

Number of subjects for this age range:

220

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

Yes

F.1.1.5.1

Number of subjects for this age range:

220

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

They are children. Their parents or legal tutor must sign informed consent.

Son niños. Sus padres o su tutor legal deben firmar el consentimiento informado.

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

220

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2019-09-16

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-06-11

P. End of Trial
P.	End of Trial Status	Ongoing

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials