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Ramdomized phaseII trial of concurrent antiemetics with oral rehydration therapy for children with vomiting in the result of acute gastroentiritis

Ramdomized phaseII trial of concurrent antiemetics with oral rehydration therapy for children with vomiting in the result of acute gastroentiritis - Ramdomized phaseII of domperidon vs. ondansetron on ORT for acute gastroenteritis in children

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000001813
Enrollment
70
Registered
2009-03-30
Start date
2009-03-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute gastroenteritis

Interventions

simple oral ondansetron prior to oral rehydration therapy (ORT) by WHO method simple domperidon suppository pior to ORT by WHO method

Sponsors

Metropolitan clinical research network for acute illness in children
Lead Sponsor
J-CRSU
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. having vomitting episode within 4 hours 2. bloody, biliary vomiting within 24 hours. 3. no nausea or vomiting episodes before 24 hours to one week 4. at least one moderate symptom and less than two severe symptom in Stephan B Freedman's dehydration score. in case over 24 months old, 'tears' symptom is not assessible one. 5. no following symptoms. decreased contious level, irritable, decreased acitivity 6. 6 months old to 10 years old 7. 8kg body weight or more 8. having chronic diseases 9. no history of abdominal open surgery 10. no use of steroid within a week 11. no use of antiemetics within 24 hours 12. no cough episodes which is possible to induce vomiting 13. written informed conscent

Exclusion criteria

Exclusion criteria: none

Design outcomes

Primary

MeasureTime frame
proportion of children having vomiting episodes during ORT

Secondary

MeasureTime frame
-Proportion of children excervated on dehydration status -Number of vomiting episode -Volume of oral rehydration salt -Proportion of need for intravenous fluid / administration -Adverse events -(Revisit rates) -problems of ORT education at outpatients section

Countries

Japan

Contacts

Public ContactYoshihiko Morikawa

Metropolitan clinical research network for acute illness in children coodinating office

yoshihiko_morikawa@tmhp.jp042-300-5111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026