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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000001813
Receipt No. 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

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Basic information
Public title Ramdomized phaseII trial of concurrent antiemetics with oral rehydration therapy for children with vomiting in the result of acute gastroentiritis
Acronym Ramdomized phaseII of domperidon vs. ondansetron on ORT for acute gastroenteritis in children
Scientific Title Ramdomized phaseII trial of concurrent antiemetics with oral rehydration therapy for children with vomiting in the result of acute gastroentiritis
Scientific Title:Acronym Ramdomized phaseII of domperidon vs. ondansetron on ORT for acute gastroenteritis in children
Region
Japan

Condition
Condition acute gastroenteritis
Classification by specialty
Pediatrics Emergency medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes proportion of children having vomiting episodes during ORT
Key secondary outcomes -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

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 simple oral ondansetron prior to oral rehydration therapy (ORT) by WHO method
Interventions/Control_2 simple domperidon suppository pior to ORT by WHO method
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
1 years-old <=
Age-upper limit
10 years-old >=
Gender Male and Female
Key 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
Key exclusion criteria none
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaru Miura
Organization Tokyo Metropolitan Children's Medical Center
Division name Cardiology, Clinical Research Support Center
Zip code
Address 2-8-29 Musashidai, Fuchu, Tokyo, Japan Musashidai, Fuchu, Tokyo, Japan
TEL 042-300-5111
Email masaru_miura@tmhp.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihiko Morikawa
Organization Metropolitan clinical research network for acute illness in children
Division name coodinating office
Zip code
Address 2-8-29 Musashidai, Fuchu, Tokyo, JapanMusashidai, Fuchu, Tokyo, Japan
TEL 042-300-5111
Homepage URL http://metroped-research.jp/
Email yoshihiko_morikawa@tmhp.jp

Sponsor
Institute Metropolitan clinical research network for acute illness in children
Institute
Department

Funding Source
Organization Tokyo metropolitan government
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor J-CRSU
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 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

Other administrative information
Date of disclosure of the study information
2009 Year 03 Month 30 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2009 Year 03 Month 27 Day
Date of IRB
Anticipated trial start date
2009 Year 03 Month 01 Day
Last follow-up date
2011 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 03 Month 30 Day
Last modified on
2015 Year 05 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002188

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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