Symptomatic Treatment of Acute Gastroenteritis

NCT ID: NCT01257672

Last Updated: 2014-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 356 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2013-11-30

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.

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

Conditions

Gastroenteritis; Vomiting; Acute Gastroenteritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

ondansetron

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

Group Type: EXPERIMENTAL

Ondansetron

Intervention Type: DRUG

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

domperidon

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

Group Type: ACTIVE_COMPARATOR

Domperidone

Intervention Type: DRUG

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

placebo

placebo, syrup, one dose

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

placebo

Interventions

Ondansetron

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

Intervention Type: DRUG

Domperidone

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

Intervention Type: DRUG

placebo

placebo

Intervention Type: DRUG

Other Intervention Names

zofran; Motilium

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mario Negri Institute for Pharmacological Research

OTHER

Sponsor Role: collaborator

Agenzia Italiana del Farmaco

OTHER_GOV

Sponsor Role: collaborator

IRCCS Burlo Garofolo

OTHER

Sponsor Role: lead

Responsible Party

Ronfani Luca

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Federico Marchetti, MD

Role: STUDY_CHAIR

IRCCS Burlo Garofolo

Maurizio Bonati, MD

Role: STUDY_DIRECTOR

Mario Negri Institute for Pharmacological Research

Locations

Dipartimento di Pediatria, Ospedale Castelli

Verbania, Novara, 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

Florence, , 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

Padua, , 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

Unità di Terapia Intensiva Pediatrica, Ospedale Civile Maggiore

Verona, , Italy

Countries

Italy

References

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.

Reference Type: BACKGROUND

PMID: 21310051 (View on PubMed)

Other Identifiers

2010-019787-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

FARM8E53XM

Identifier Type: -

Identifier Source: org_study_id