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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001371
Receipt No. 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

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

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
URL(English) https://upload.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


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