Symptomatic Treatment of Acute Gastroenteritis

Vomiting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01257672
• Other study ID #: FARM8E53XM
• Secondary ID: 2010-019787-36
• Status: Completed
• Phase: Phase 3
• First received: December 9, 2010
• Last updated: April 17, 2014
• Start date: July 2011
• Est. completion date: November 2013

Study information

• Verified date: April 2014
• Source: IRCCS Burlo Garofolo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 356
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 6 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Gastroenteritis
• Gastroenteritis
• Vomiting

Intervention

Drug:
• Ondansetron
ondansetron syrup (0,15 mg/Kg of body weight)
• Domperidone
domperidone syrup (0,5 mg/Kg of body weight)
• placebo
placebo

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
IRCCS Burlo Garofolo	Agenzia Italiana del Farmaco, Mario Negri Institute for Pharmacological Research

Country where clinical trial is conducted

Italy, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Percentage of subjects needing hospital admission for the same illness;		48 hours	No
Secondary	Percentage of subjects needing observation stay for more than 6 hours for the same illness		48 hours	No
Secondary	Total emesis duration in the 3 allocation groups;		48 hours	No
Secondary	Number of episodes of vomiting in the 3 treatment groups during the follow-up period		48 hours	No
Secondary	Percentage of subjects presenting adverse events		48 hours	Yes