Status:
COMPLETED
Symptomatic Treatment of Acute Gastroenteritis
Lead Sponsor:
IRCCS Burlo Garofolo
Collaborating Sponsors:
Mario Negri Institute for Pharmacological Research
Agenzia Italiana del Farmaco
Conditions:
Gastroenteritis
Vomiting
Eligibility:
All Genders
1-6 years
Phase:
PHASE3
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...
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...
Eligibility Criteria
Inclusion
- age from 1 to 6 years;
- presumptive clinical diagnosis of acute gastroenteritis in patients with vomiting, with or without diarrhoea;
- more than three episodes of non-bilious, non-bloody vomiting within the previous 24 hours;
Exclusion
- treatment with antiemetics or antidiarrhoic drugs in the 6 hours prior to access to ED;
- underlying chronic diseases (eg, malignancy, gastroesophageal reflux, migraine, renal failure, hypoalbuminemia, liver disease);
- severe dehydration: weight loss\>10% or standardized clinical dehydration score \>=18 for children aged 12-24 months and \>=16 for older children;
- known hypersensitivity to ondansetron or domperidone;
- previous enrolment in the study.
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
356 Patients enrolled
Trial Details
Trial ID
NCT01257672
Start Date
July 1 2011
End Date
November 1 2013
Last Update
April 21 2014
Active Locations (15)
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1
Dipartimento di Pediatria, Ospedale Castelli
Verbania, Novara, Italy
2
Dipartimento di Emergenza Pediatrica, Ospedale Giuseppe Moscati
Avellino, Italy
3
Dipartimento di Emergenza Pediatrica, P.O. Spedali Civili
Brescia, Italy
4
Divisione di Emergenza Pediatrica, Ospedale Pediatrico A. Meyer
Florence, Italy