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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000015643
Receipt No. R000018184
Scientific Title HP registory for junior and senior high school students
Date of disclosure of the study information 2014/11/09
Last modified on 2018/05/13

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Basic information
Public title HP registory for junior and senior high school students
Acronym HP registory for junior and senior high school students
Scientific Title HP registory for junior and senior high school students
Scientific Title:Acronym HP registory for junior and senior high school students
Region
Japan

Condition
Condition H.pylori associated chronic gastritis
Classification by specialty
Medicine in general Gastroenterology Infectious disease
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the eradication rate and side effect of H.pylori eradication therapy for junior high school and high school students in Japan
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes the rate of each regimen of H.pylori eradication,
compliance,
frequency and type of side effect,
eradication rate
Key secondary outcomes The eradication rate and side effect by the regimens of H.pylori eradication therapy,
the seriousness of adverse effects and the rate of severe side effect.
outcome of treatment for the side effect

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
12 years-old <=
Age-upper limit
18 years-old >=
Gender Male and Female
Key inclusion criteria All junior high school and high school students(age:12-18) who receive the H.pylori eradication therapy.
Key exclusion criteria Patients or/and one's parents refuse the entry to this registry.
Target sample size 3000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuichi Shimizu
Organization Hokkaido University Hospital
Division name Division of Endoscopy
Zip code
Address N14,W5,Kita-ku,Sapporo,Hokkaido
TEL 011-716-1161
Email yshimizu@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name katsuhiro Mabe
Organization National Hospital Organization Hakodate Hospital
Division name Dept og Gastroenterology
Zip code
Address 18-16, Kawahara, Hakodate city, Hokkaido
TEL 0138-51-6281
Homepage URL http://www.jshr-pylori.jp
Email katsumabe@me.com

Sponsor
Institute The Japanese society of Helicobacter Research
Institute
Department

Funding Source
Organization The Japanese society of Helicobacter Research
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
2014 Year 11 Month 09 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
2014 Year 08 Month 27 Day
Date of IRB
Anticipated trial start date
2014 Year 12 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 rate of eradication and , adverse effect of eradication therapy

Management information
Registered date
2014 Year 11 Month 09 Day
Last modified on
2018 Year 05 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018184

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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