Symptomatic Treatment of Acute Gastroenteritis

This study is currently recruiting participants.
Verified October 2013 by IRCCS Burlo Garofolo
Sponsor:
Collaborators:
Mario Negri Institute for Pharmacological Research
Agenzia Italiana del Farmaco
Information provided by (Responsible Party):
Ronfani Luca, IRCCS Burlo Garofolo
ClinicalTrials.gov Identifier:
NCT01257672
First received: December 9, 2010
Last updated: October 15, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Gastroenteritis
Vomiting
Acute Gastroenteritis
Drug: Ondansetron
Drug: Domperidone
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Oral Ondansetron vs Domperidone for Symptomatic Treatment of Vomiting During Acute Gastroenteritis in Children: Multicentre Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by IRCCS Burlo Garofolo:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of subjects needing hospital admission for the same illness; [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Percentage of subjects needing observation stay for more than 6 hours for the same illness [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Total emesis duration in the 3 allocation groups; [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Number of episodes of vomiting in the 3 treatment groups during the follow-up period [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Percentage of subjects presenting adverse events [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 540
Study Start Date: July 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ondansetron
ondansetron syrup (0,15 mg/Kg of body weight)
Drug: Ondansetron
ondansetron syrup (0,15 mg/Kg of body weight)
Other Name: zofran
Active Comparator: domperidon
domperidone syrup (0,5 mg/Kg of body weight)
Drug: Domperidone
domperidone syrup (0,5 mg/Kg of body weight)
Other Name: Motilium
Placebo Comparator: placebo Drug: placebo
placebo
Other Name: placebo

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

Ages Eligible for Study:   1 Year to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01257672

Contacts
Contact: Luca Ronfani, MD, PhD 0039/040/3785 ext 401 ronfani@burlo.trieste.it
Contact: Lorenzo Monasta, DSc, MSc 0039/040/3785 ext 520 monasta@burlo.trieste.it

Locations
Italy
Dipartimento di Pediatria, Ospedale Castelli Recruiting
Verbania, Novara, Italy
Principal Investigator: Andrea Guala, MD         
Dipartimento di Emergenza Pediatrica, Ospedale Giuseppe Moscati Recruiting
Avellino, Italy
Principal Investigator: Antonio Vitale, MD         
Dipartimento di Emergenza Pediatrica, P.O. Spedali Civili Recruiting
Brescia, Italy
Principal Investigator: Alberto Arrighini, MD         
Divisione di Emergenza Pediatrica, Ospedale Pediatrico A. Meyer Recruiting
Firenze, Italy
Principal Investigator: Francesco Mannelli, MD         
Sub-Investigator: Anna Pazzaglia, MD         
Unità Operativa di Pediatria, Ospedale GB Morgagni Recruiting
Forlì, Italy
Principal Investigator: Enrico Valletta, MD         
Divisione di Emergenza Pediatrica, Istituto G. Gaslini Recruiting
Genova, Italy
Principal Investigator: Pasquale Di Pietro, MD         
Sub-Investigator: Salvatore Renna, MD         
Dipartimento di Pediatrica, Ospedale di Macerata Recruiting
Macerata, Italy
Principal Investigator: Paolo Francesco Perri, MD         
Dipartimento di Pediatria, Azienda Policlinico di Modena Recruiting
Modena, Italy
Principal Investigator: Paolo Bertolani, MD         
Dipartimento di Emergenza Pediatrica, Azienda Ospedaliera - Università di Padova Recruiting
Padova, Italy
Principal Investigator: Tiziana Zangardi, MD         
Dipartimento di Pediatrica, Azienda Ospedaliera- Università di Parma Recruiting
Parma, Italy
Principal Investigator: Maria Teresa Tondelli, MD         
Dipartimento di Emergenza Pediatrica, Ospedale Pediatrico IRCCS Bambino Gesú Recruiting
Roma, Italy
Principal Investigator: Antonino Reale, MD         
Dipartimento di Emergenza Pediatrica, Ospedale Infantile Regina Margherita Recruiting
Torino, Italy
Principal Investigator: Antonio Francesco Urbino, MD         
Dipartimento di Pediatria, Ospedale di Treviso Recruiting
Treviso, Italy
Principal Investigator: Liviana Da Dalt, MD         
Dipartimento di Emergenza Pediatrica, Istituto per la l'Infanzia, IRCCS Burlo Garofolo Recruiting
Trieste, Italy
Principal Investigator: Gianni Messi, MD         
Principal Investigator: Egidio Barbi, MD         
Sub-Investigator: Lorenzo Calligaris, MD         
Unità di Terapia Intensiva Pediatrica, Ospedale Civile Maggiore Recruiting
Verona, Italy
Principal Investigator: Paolo Biban, MD         
Sponsors and Collaborators
IRCCS Burlo Garofolo
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
  More Information

Publications:
Responsible Party: Ronfani Luca, MD, IRCCS Burlo Garofolo
ClinicalTrials.gov Identifier: NCT01257672     History of Changes
Other Study ID Numbers: FARM8E53XM, 2010-019787-36
Study First Received: December 9, 2010
Last Updated: October 15, 2013
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by IRCCS Burlo Garofolo:
acute gastroenteritis
vomiting
ondansetron
domperidon
symptomatic treatment

Additional relevant MeSH terms:
Gastroenteritis
Vomiting
Gastrointestinal Diseases
Digestive System Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Domperidone
Ondansetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents

ClinicalTrials.gov processed this record on April 17, 2014