UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001371
Receipt number R000001526
Scientific Title For appropriate use of antiemetics with ORT for child gastroenteritis (AEGE)
Date of disclosure of the study information 2008/09/12
Last modified on 2012/02/26 18:17:21

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Basic information

Public title

For appropriate use of antiemetics with ORT for child gastroenteritis
(AEGE)

Acronym

For appropriate use of anti-emetics with ORT

Scientific Title

For appropriate use of antiemetics with ORT for child gastroenteritis
(AEGE)

Scientific Title:Acronym

For appropriate use of anti-emetics with ORT

Region

Japan


Condition

Condition

Infectious gastroenteritis

Classification by specialty

Pediatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Examine anti-emetics in the efficacy with ORT for child gastroenteritis

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

Rate of patient who have any vomiting in this study

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine Food

Interventions/Control_1

ORT

Interventions/Control_2

ORT and prescription of antiemetics

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

6 years-old >

Gender

Male and Female

Key inclusion criteria

Patients had at least one reported
episode of nonbilious, nonbloody
vomiting within the four hours preceding triage
Patients with symptoms consistent with gastroenteritis
Written informed consent
6 month through 10 years of age

Key exclusion criteria

Under 6 month or body weight of less than 8 kg
Patients had an episode of diarrhea during 1week
Patients had an treatment for this disease on the day before
Severe dehydration
Patients had underlying disease that could affect the assessment of hydration (renal failure or hypo -albuminemia)
Hypersensitivity to domperidone
Patients with known intolerance to domperidone
Patients had an blood stools or clearly bacterial gastroenteirtis
Patients who are not received treatment at home

Target sample size

162


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Koji Kawakami

Organization

Kyoto University Graduate School of Medicine and Public Health

Division name

Department of Pharmacoepidemiology

Zip code


Address

Konoe-cho Yoshida Sakyo-ku Kyoto

TEL

075-753-9469

Email



Public contact

Name of contact person

1st name
Middle name
Last name Fumiyo Kita

Organization

Kyoto University Graduate School of Medicine and Public Health

Division name

Department of Pharmacoepidemiology

Zip code


Address


TEL

075-753-9469

Homepage URL


Email

kita-fumiyo@umin.ac.jp


Sponsor or person

Institute

Kyoto University Graduate School of Medicine and Public Health Department of Pharmacoepidemiology

Institute

Department

Personal name



Funding Source

Organization

INAMORI FOUNDATION

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor


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



Other administrative information

Date of disclosure of the study information

2008 Year 09 Month 12 Day


Related information

URL releasing protocol


Publication of results

Published


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

Completed

Date of protocol fixation

2008 Year 03 Month 31 Day

Date of IRB


Anticipated trial start date

2008 Year 09 Month 01 Day

Last follow-up date

2009 Year 06 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

2008 Year 09 Month 12 Day

Last modified on

2012 Year 02 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001526


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name