UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001813
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

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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 or person

Institute

Metropolitan clinical research network for acute illness in children

Institute

Department

Personal name



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

Value
https://center6.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