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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012115
Receipt No. R000014146
Scientific Title Elucidation of pathogenesis and surveillance of rotavirus infection associated encephalopathy, sudden unexpected death, gastrointestinal bleeding and urinary tract stone cases in Aichi Prefecture
Date of disclosure of the study information 2013/10/25
Last modified on 2018/10/29

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Basic information
Public title Elucidation of pathogenesis and surveillance of rotavirus infection associated encephalopathy, sudden unexpected death, gastrointestinal bleeding and urinary tract stone cases in Aichi Prefecture
Acronym Elucidation of pathogenesis and surveillance of rotavirus infection severe cases in Aichi Prefecture
Scientific Title Elucidation of pathogenesis and surveillance of rotavirus infection associated encephalopathy, sudden unexpected death, gastrointestinal bleeding and urinary tract stone cases in Aichi Prefecture
Scientific Title:Acronym Elucidation of pathogenesis and surveillance of rotavirus infection severe cases in Aichi Prefecture
Region
Japan

Condition
Condition Rotavirus infection
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Elucidation of frequency and pathogenesis of severe complications caused by
rotavirus infection such as encephalopathy, sudden unexpected death,
gastrointestinal bleeding, and urinary tract stone.
Basic objectives2 Others
Basic objectives -Others Epidemiology and pathogenesis
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. The incidence of severe complications caused by rotavirus infection such
as encephalopathy, sudden unexpected death, gastrointestinal bleeding, and
urinary tract stone.
2. Trends in frequency of rotavirus infection associated severe complication
after introduction of rotavirus vaccine.
3. Elucidation of pathogenesis of severe complication caused by rotavirus
infection.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
15 years-old >=
Gender Male and Female
Key inclusion criteria Cases with severe complications caused by
rotavirus infection such as encephalopathy, sudden unexpected death,
gastrointestinal bleeding, and urinary tract stone in Aichi prefecture, Japan.
Key exclusion criteria Children in the exception of Aichi.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiki Kawamura
Organization Fujita Health University School of Medicine
Division name Pediatrics
Zip code
Address 1-98 Dengakugakubo Kutsukake-cho Toyoake city Aichi 470-1192 Japan
TEL 0562-93-9251
Email kyoshiki3@hotmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiki Kawamura
Organization Fujita Health University School of Medicine
Division name Pediatrics
Zip code
Address 1-98 Dengakugakubo Kutsukake-cho Toyoake city Aichi 470-1192 Japan
TEL 0562-93-9251
Homepage URL
Email kyoshiki3@hotmail.com

Sponsor
Institute Fujita Health University School of Medicine
Institute
Department

Funding Source
Organization Nothing
Organization
Division
Category of Funding Organization Other
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
2013 Year 10 Month 25 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
2013 Year 10 Month 24 Day
Date of IRB
Anticipated trial start date
2014 Year 01 Month 01 Day
Last follow-up date
2018 Year 10 Month 29 Day
Date of closure to data entry
2018 Year 10 Month 29 Day
Date trial data considered complete
2018 Year 10 Month 29 Day
Date analysis concluded
2018 Year 10 Month 29 Day

Other
Other related information There is no information for the preinitiation.

Management information
Registered date
2013 Year 10 Month 24 Day
Last modified on
2018 Year 10 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014146

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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