Symptomatic Treatment of Acute Gastroenteritis

April 17, 2014 updated by: Ronfani Luca, IRCCS Burlo Garofolo

Oral Ondansetron vs Domperidone for Symptomatic Treatment of Vomiting During Acute Gastroenteritis in Children: Multicentre Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Vomiting in children with acute gastroenteritis (AG) is not only a direct cause of fluid loss but it is also a major factor of failure of oral rehydration therapy (ORT). Physicians who provide care to paediatric patients in the emergency department (ED) usually prescribe intravenous fluid therapy (IVT) for mild or moderate dehydration when vomiting is the major symptom. Thus, effective symptomatic treatment of vomiting would lead to an important reduction in the use of IVT and, consequently, of the duration of hospital stay and of frequency of hospital admission. 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 conducted in paediatric Emergency Departments is to compare the efficacy of ondansetron and domperidone for the symptomatic treatment of vomiting in children with AG who have failed Oral Rehydration Therapy.

The trial results would provide evidence on the efficacy of domperidone, which is largely used in clinical practice despite the lack of proper evaluation and a controversial safety profile, as compared to ondansetron, which is not yet authorized in Italy despite evidence supporting its efficacy in treating vomiting. The trial results would contribute to a reduction in the use of IVT and, consequently, in hospital admissions in children with AG. The design of this RCT, which closely reflect current clinical practice in EDs, will allow immediate transferability of results

Study Type

Interventional

Enrollment (Actual)

356

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Avellino, Italy
        • Dipartimento di Emergenza Pediatrica, Ospedale Giuseppe Moscati
      • Brescia, Italy
        • Dipartimento di Emergenza Pediatrica, P.O. Spedali Civili
      • Firenze, Italy
        • Divisione di Emergenza Pediatrica, Ospedale Pediatrico A. Meyer
      • Forlì, Italy
        • Unità Operativa di Pediatria, Ospedale GB Morgagni
      • Genova, Italy
        • Divisione di Emergenza Pediatrica, Istituto G. Gaslini
      • Macerata, Italy
        • Dipartimento di Pediatrica, Ospedale di Macerata
      • Modena, Italy
        • Dipartimento di Pediatria, Azienda Policlinico di Modena
      • Padova, Italy
        • Dipartimento di Emergenza Pediatrica, Azienda Ospedaliera - Università di Padova
      • Parma, Italy
        • Dipartimento di Pediatrica, Azienda Ospedaliera- Università di Parma
      • Roma, Italy
        • Dipartimento di Emergenza Pediatrica, Ospedale Pediatrico IRCCS Bambino Gesú
      • Torino, Italy
        • Dipartimento di Emergenza Pediatrica, Ospedale Infantile Regina Margherita
      • Treviso, Italy
        • Dipartimento di Pediatria, Ospedale di Treviso
      • Trieste, Italy
        • Dipartimento di Emergenza Pediatrica, Istituto per la l'Infanzia, IRCCS Burlo Garofolo
      • Verona, Italy
        • Unità di Terapia Intensiva Pediatrica, Ospedale Civile Maggiore
    • Novara
      • Verbania, Novara, Italy
        • Dipartimento di Pediatria, Ospedale Castelli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 months to 4 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ondansetron
ondansetron, syrup, 0,15 mg/Kg of body weight, 1 dose
Drug: Ondansetron
ondansetron syrup (0,15 mg/Kg of body weight)
Other Names:
  • zofran
Active Comparator: domperidon
domperidone, syrup, 0,5 mg/Kg of body weight, one dose
Drug: Domperidone
domperidone syrup (0,5 mg/Kg of body weight)
Other Names:
  • Motilium
Placebo Comparator: placebo
placebo, syrup, one dose
Drug: placebo
placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 6 hours
6 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of subjects needing hospital admission for the same illness;
Time Frame: 48 hours
48 hours
Percentage of subjects needing observation stay for more than 6 hours for the same illness
Time Frame: 48 hours
48 hours
Total emesis duration in the 3 allocation groups;
Time Frame: 48 hours
48 hours
Number of episodes of vomiting in the 3 treatment groups during the follow-up period
Time Frame: 48 hours
48 hours
Percentage of subjects presenting adverse events
Time Frame: 48 hours
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Burlo Garofolo

Collaborators

Mario Negri Institute for Pharmacological Research
Agenzia Italiana del Farmaco

Investigators

  • Study Chair: Federico Marchetti, MD, IRCCS Burlo Garofolo
  • Study Director: Maurizio Bonati, MD, Mario Negri Institute for Pharmacological Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

December 9, 2010

First Submitted That Met QC Criteria

December 9, 2010

First Posted (Estimate)

December 10, 2010

Study Record Updates

Last Update Posted (Estimate)

April 21, 2014

Last Update Submitted That Met QC Criteria

April 17, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FARM8E53XM
  • 2010-019787-36 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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