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Symptomatic Treatment of Acute Gastroenteritis

NCT01257672 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 356

Last updated 2014-04-21

No results posted yet for this study

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

Interventions

DRUG

Ondansetron

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

DRUG

Domperidone

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

DRUG

placebo

placebo

Sponsors & Collaborators

  • Mario Negri Institute for Pharmacological Research

    collaborator OTHER

  • Agenzia Italiana del Farmaco

    collaborator OTHER_GOV

  • IRCCS Burlo Garofolo

    lead OTHER

Principal Investigators

  • Federico Marchetti, MD · IRCCS Burlo Garofolo

  • Maurizio Bonati, MD · Mario Negri Institute for Pharmacological Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01257672 on ClinicalTrials.gov