Symptomatic Treatment of Acute Gastroenteritis

This study has been completed.
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: April 17, 2014
Last verified: April 2014
  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 ]

Enrollment: 356
Study Start Date: July 2011
Study Completion Date: November 2013
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, 1 dose
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, one dose
Drug: Domperidone
domperidone syrup (0,5 mg/Kg of body weight)
Other Name: Motilium
Placebo Comparator: placebo
placebo, syrup, one dose
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01257672

Locations
Italy
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
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
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: April 17, 2014
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
Digestive System Diseases
Gastrointestinal Diseases
Signs and Symptoms
Signs and Symptoms, Digestive
Domperidone
Ondansetron
Anti-Anxiety Agents
Antiemetics
Antipruritics
Antipsychotic Agents
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dermatologic Agents
Dopamine Agents
Dopamine Antagonists
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 22, 2014