Symptomatic Treatment of Acute Gastroenteritis

NCT01257672 | Completed Phase 3 DMC

• 2 other identifiers: FARM8E53XM2010-019787-36
• Study Type: interventional
• Target: 356
• Locations: 1 country
• Sites: 15

Brief Summary

Vomiting in children with acute gastroenteritis is a major factor of failure of oral rehydration therapy. Effective symptomatic treatment of vomiting would lead to an important reduction in the use of Intravenous Fluid Therapy. Available evidence on symptomatic treatment of vomiting shows the efficacy of the most recently registered molecule (ondansetron) but a proper evaluation of antiemetics drugs largely used in clinical practice, such as domperidone, is lacking. The aim of this multicentre, double-blind randomized controlled trial is to compare the efficacy of ondansetron and domperidone for the symptomatic treatment of vomiting in children with acute gastroenteritis who have failed Oral Rehydration Therapy.

Conditions

Gastroenteritis; Vomiting; Acute Gastroenteritis

Keywords

acute gastroenteritis; vomiting; ondansetron; domperidon; symptomatic treatment

Outcome Measures

Primary Outcomes (1)

• Percentage of patients needing nasogastric or intravenous rehydration after symptomatic oral treatment failure, defined as vomiting or fluid refusal after the second attempt of ORT.

  6 hours

Secondary Outcomes (5)

• Percentage of subjects needing hospital admission for the same illness;

  48 hours

• Percentage of subjects needing observation stay for more than 6 hours for the same illness

  48 hours

• Total emesis duration in the 3 allocation groups;

  48 hours

• Number of episodes of vomiting in the 3 treatment groups during the follow-up period

  48 hours

• Percentage of subjects presenting adverse events

  48 hours

Study Arms (3)

ondansetron

EXPERIMENTAL

ondansetron, syrup, 0,15 mg/Kg of body weight, 1 dose

Drug: Ondansetron

domperidon

ACTIVE COMPARATOR

domperidone, syrup, 0,5 mg/Kg of body weight, one dose

Drug: Domperidone

placebo

PLACEBO COMPARATOR

placebo, syrup, one dose

Drug: placebo

Interventions

Ondansetron DRUG

ondansetron syrup (0,15 mg/Kg of body weight)

Also known as: zofran

ondansetron

Domperidone DRUG

domperidone syrup (0,5 mg/Kg of body weight)

Also known as: Motilium

domperidon

placebo DRUG

placebo

placebo

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• age from 1 to 6 years;
• presumptive clinical diagnosis of acute gastroenteritis in patients with vomiting, with or without diarrhoea;
• more than three episodes of non-bilious, non-bloody vomiting within the previous 24 hours;

You may not qualify if:

• treatment with antiemetics or antidiarrhoic drugs in the 6 hours prior to access to ED;
• underlying chronic diseases (eg, malignancy, gastroesophageal reflux, migraine, renal failure, hypoalbuminemia, liver disease);
• severe dehydration: weight loss\>10% or standardized clinical dehydration score \>=18 for children aged 12-24 months and \>=16 for older children;
• known hypersensitivity to ondansetron or domperidone;
• previous enrolment in the study.

Sponsors & Collaborators

• IRCCS Burlo Garofolo: lead
• Mario Negri Institute for Pharmacological Research: collaborator
• Agenzia Italiana del Farmaco: collaborator

Study Sites (15)

Dipartimento di Pediatria, Ospedale Castelli

Verbania, Novara, Italy

Location

Dipartimento di Emergenza Pediatrica, Ospedale Giuseppe Moscati

Avellino, Italy

Location

Dipartimento di Emergenza Pediatrica, P.O. Spedali Civili

Brescia, Italy

Location

Divisione di Emergenza Pediatrica, Ospedale Pediatrico A. Meyer

Florence, Italy

Location

Unità Operativa di Pediatria, Ospedale GB Morgagni

Forlì, Italy

Location

Divisione di Emergenza Pediatrica, Istituto G. Gaslini

Genova, Italy

Location

Dipartimento di Pediatrica, Ospedale di Macerata

Macerata, Italy

Location

Dipartimento di Pediatria, Azienda Policlinico di Modena

Modena, Italy

Location

Dipartimento di Emergenza Pediatrica, Azienda Ospedaliera - Università di Padova

Padua, Italy

Location

Dipartimento di Pediatrica, Azienda Ospedaliera- Università di Parma

Parma, Italy

Location

Dipartimento di Emergenza Pediatrica, Ospedale Pediatrico IRCCS Bambino Gesú

Roma, Italy

Location

Dipartimento di Emergenza Pediatrica, Ospedale Infantile Regina Margherita

Torino, Italy

Location

Dipartimento di Pediatria, Ospedale di Treviso

Treviso, Italy

Location

Dipartimento di Emergenza Pediatrica, Istituto per la l'Infanzia, IRCCS Burlo Garofolo

Trieste, Italy

Location

Unità di Terapia Intensiva Pediatrica, Ospedale Civile Maggiore

Verona, Italy

Location

Related Publications (1)

• Marchetti F, Maestro A, Rovere F, Zanon D, Arrighini A, Bertolani P, Biban P, Da Dalt L, Di Pietro P, Renna S, Guala A, Mannelli F, Pazzaglia A, Messi G, Perri F, Reale A, Urbino AF, Valletta E, Vitale A, Zangardi T, Tondelli MT, Clavenna A, Bonati M, Ronfani L. Oral ondansetron versus domperidone for symptomatic treatment of vomiting during acute gastroenteritis in children: multicentre randomized controlled trial. BMC Pediatr. 2011 Feb 10;11:15. doi: 10.1186/1471-2431-11-15.

  PMID: 21310051 BACKGROUND

MeSH Terms

Conditions

Gastroenteritis; Vomiting

Interventions

Ondansetron; Domperidone

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Piperidines; Benzimidazoles

Study Officials

• Federico Marchetti, MD

  IRCCS Burlo Garofolo

  STUDY CHAIR

• Maurizio Bonati, MD

  Mario Negri Institute for Pharmacological Research

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 9, 2010
• First Posted: December 10, 2010
• Study Start: July 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: April 21, 2014

Record last verified: 2014-04

Locations

IT (15)