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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000014727
Receipt No. R000017121
Scientific Title Eradication therapy of the junior high student in H. pylori
Date of disclosure of the study information 2014/08/01
Last modified on 2016/08/02

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Basic information
Public title Eradication therapy of the junior high student in H. pylori
Acronym H. pylori eradication of the junior high student
Scientific Title Eradication therapy of the junior high student in H. pylori
Scientific Title:Acronym H. pylori eradication of the junior high student
Region
Japan

Condition
Condition H. pylori infection
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 H. pylori eradication
Basic objectives2 Others
Basic objectives -Others prevention of H. pylori associated diseases
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes H. pylori eradication
Key secondary outcomes Evaluation of H. pylori associated diseases

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 eradication therapy
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
12 years-old <=
Age-upper limit
14 years-old >=
Gender Male and Female
Key inclusion criteria Helicobacter pyroli infection
Key exclusion criteria Past history of Helicobacter pyroli eradication
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Tamai
Organization Osaka Medical College
Division name Dep. of Pediatrics
Zip code
Address 2-7, Daigakumachi,Takatsuki, Osaka, Japan
TEL 072-683-1221
Email ped001@osaka-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsushi Yoden
Organization Osaka Medical College
Division name Dep. of Pediatrics
Zip code
Address 2-7, Daigakumachi,Takatsuki, Osaka, Japan
TEL 072-683-1221
Homepage URL
Email ped018@osaka-med.ac.jp

Sponsor
Institute Takatsuki city health center
Institute
Department

Funding Source
Organization Takatsuki city
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor none
Name of secondary funder(s) none

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 大阪医科大学附属病院

Other administrative information
Date of disclosure of the study information
2014 Year 08 Month 01 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 Preinitiation
Date of protocol fixation
2014 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 07 Month 31 Day
Last modified on
2016 Year 08 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017121

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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