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

December 9, 2010
April 17, 2014
July 2011
November 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01257672 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Symptomatic Treatment of Acute Gastroenteritis
Oral Ondansetron vs Domperidone for Symptomatic Treatment of Vomiting During Acute Gastroenteritis in Children: Multicentre Randomized Controlled Trial

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.

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Gastroenteritis
  • Vomiting
  • Acute Gastroenteritis
  • Drug: Ondansetron
    ondansetron syrup (0,15 mg/Kg of body weight)
    Other Name: zofran
  • Drug: Domperidone
    domperidone syrup (0,5 mg/Kg of body weight)
    Other Name: Motilium
  • Drug: placebo
    placebo
    Other Name: placebo
  • Experimental: ondansetron
    ondansetron, syrup, 0,15 mg/Kg of body weight, 1 dose
    Intervention: Drug: Ondansetron
  • Active Comparator: domperidon
    domperidone, syrup, 0,5 mg/Kg of body weight, one dose
    Intervention: Drug: Domperidone
  • Placebo Comparator: placebo
    placebo, syrup, one dose
    Intervention: Drug: placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
356
November 2013
November 2013   (final data collection date for primary outcome measure)

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.
Both
1 Year to 6 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01257672
FARM8E53XM, 2010-019787-36
Yes
Ronfani Luca, IRCCS Burlo Garofolo
IRCCS Burlo Garofolo
  • Mario Negri Institute for Pharmacological Research
  • Agenzia Italiana del Farmaco
Study Chair: Federico Marchetti, MD IRCCS Burlo Garofolo
Study Director: Maurizio Bonati, MD Mario Negri Institute for Pharmacological Research
IRCCS Burlo Garofolo
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP