UMIN-CTR Clinical Trial

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	Completed
Date of protocol fixation	2014 Year 08 Month 27 Day
Date of IRB	2014 Year 08 Month 26 Day
Anticipated trial start date	2014 Year 12 Month 01 Day
Last follow-up date	2020 Year 03 Month 30 Day
Date of closure to data entry	2020 Year 04 Month 30 Day
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	2019 Year 11 Month 13 Day

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