Symptomatic Treatment of Acute Gastroenteritis
Information source: IRCCS Burlo Garofolo
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gastroenteritis; Vomiting; Acute Gastroenteritis
Intervention: Ondansetron (Drug); Domperidone (Drug); placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: IRCCS Burlo Garofolo Official(s) and/or principal investigator(s): Federico Marchetti, MD, Study Chair, Affiliation: IRCCS Burlo Garofolo Maurizio Bonati, MD, Study Director, Affiliation: Mario Negri Institute for Pharmacological Research
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.
Clinical Details
Official title: Oral Ondansetron vs Domperidone for Symptomatic Treatment of Vomiting During Acute Gastroenteritis in Children: Multicentre Randomized Controlled Trial
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: 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.
Secondary outcome: Percentage of subjects needing hospital admission for the same illness;Percentage of subjects needing observation stay for more than 6 hours for the same illness Total emesis duration in the 3 allocation groups; Number of episodes of vomiting in the 3 treatment groups during the follow-up period Percentage of subjects presenting adverse events
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
Eligibility
Minimum age: 1 Year.
Maximum age: 6 Years.
Gender(s): Both.
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.
Locations and Contacts
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
Unità di Terapia Intensiva Pediatrica, Ospedale Civile Maggiore, Verona, Italy
Dipartimento di Pediatria, Ospedale Castelli, Verbania, Novara, Italy
Additional Information
Related publications: 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.
Starting date: July 2011
Last updated: April 17, 2014
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