Unique ID issued by UMIN | UMIN000001813 |
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Receipt number | R000002188 |
Scientific Title | Ramdomized phaseII trial of concurrent antiemetics with oral rehydration therapy for children with vomiting in the result of acute gastroentiritis |
Date of disclosure of the study information | 2009/03/30 |
Last modified on | 2015/05/30 22:13:23 |
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
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
Japan |
acute gastroenteritis
Pediatrics | Emergency medicine |
Others
NO
To select better medication between domperidon suppository and ondansetron syrup as antiemetic which facilitate oral rehydration in children with mild to moderate dehydration as the result of acute gastroenteritisTo select better medication between domperidon suppositorie and ondansetron syrup as antiemetic which facilitate oral rehydration in children with mild to moderate dehydration as the result of acute gastroenteritis
Efficacy
Exploratory
Pragmatic
Phase II
proportion of children having vomiting episodes during ORT
-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
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
YES
Institution is considered as adjustment factor in dynamic allocation.
NO
Central registration
2
Treatment
Medicine |
simple oral ondansetron prior to oral rehydration therapy (ORT) by WHO method
simple domperidon suppository pior to ORT by WHO method
1 | years-old | <= |
10 | years-old | >= |
Male and Female
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
none
70
1st name | |
Middle name | |
Last name | Masaru Miura |
Tokyo Metropolitan Children's Medical Center
Cardiology, Clinical Research Support Center
2-8-29 Musashidai, Fuchu, Tokyo, Japan Musashidai, Fuchu, Tokyo, Japan
042-300-5111
masaru_miura@tmhp.jp
1st name | |
Middle name | |
Last name | Yoshihiko Morikawa |
Metropolitan clinical research network for acute illness in children
coodinating office
2-8-29 Musashidai, Fuchu, Tokyo, JapanMusashidai, Fuchu, Tokyo, Japan
042-300-5111
http://metroped-research.jp/
yoshihiko_morikawa@tmhp.jp
Metropolitan clinical research network for acute illness in children
Tokyo metropolitan government
Local Government
Japan
J-CRSU
NO
都立大塚病院(東京都)
都立墨東病院(東京都)
都立小児総合医療センター
2009 | Year | 03 | Month | 30 | Day |
Unpublished
Open public recruiting
2009 | Year | 03 | Month | 27 | Day |
2009 | Year | 03 | Month | 01 | Day |
2011 | Year | 03 | Month | 01 | Day |
2009 | Year | 03 | Month | 30 | Day |
2015 | Year | 05 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002188
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