drugset / Trial / NCT01257672
Symptomatic Treatment of Acute Gastroenteritis
Phase 3
Completed
356 enrolled
IRCCS Burlo Garofolo
Agenzia Italiana del Farmaco · collabMario Negri Institute for Pharmacological Research · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2011-07
- Primary completion
- 2013-11
- Completion
- 2013-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Domperidone | Unknown | 0.5 mg/kg | Oral |
| Subject | Ondansetron | Other / unclassified | 0.15 mg/kg | Oral |