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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000001434
Receipt No. R000001686
Scientific Title Clinical trial on efficacy and safety of eradication therapy for Helicobacter pylori infection to prevent gastric cancer.
Date of disclosure of the study information 2008/10/20
Last modified on 2008/10/17

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Basic information
Public title Clinical trial on efficacy and safety of eradication therapy for Helicobacter pylori infection to prevent gastric cancer.
Acronym Helicobacter eradication for gastric cancer prevention.
Scientific Title Clinical trial on efficacy and safety of eradication therapy for Helicobacter pylori infection to prevent gastric cancer.
Scientific Title:Acronym Helicobacter eradication for gastric cancer prevention.
Region
Japan

Condition
Condition atrophic gastritis with H. pylori infection
Classification by specialty
Medicine in general Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim is to investigate efficacy and safety in long term of Helicobacter eradication for prevention of gastric cancer in the pateints with atrophic gastritis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Gastirc cancer diagnosed by endoscopy
Key secondary outcomes safety

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 Prevention
Type of intervention
Medicine
Interventions/Control_1 Eradication therapy for H. pylori infection
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
50 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. positive for H. pylroi infection
2. atrophic gastritis by endoscopy
Key exclusion criteria 1. gastric malignancies or gastric adenomas
2. gastroduodenal ulcers
3. allergy for medicine used in this study
Target sample size 1600

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keiji Ogura
Organization University of Tokyo
Division name Clinical Research Center
Zip code
Address 7-3-1 Hongo, Bunkyo-ku Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization The University of Tokyo Hospital
Division name Department of Gastroenterology
Zip code
Address
TEL 03-3815-5411
Homepage URL
Email

Sponsor
Institute Department of Gastroenterology
University of Tokyo
Institute
Department

Funding Source
Organization Department of Gastroenterology
University of Tokyo
Organization
Division
Category of Funding Organization Self funding
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 10 Month 20 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
Date of protocol fixation
2008 Year 07 Month 07 Day
Date of IRB
Anticipated trial start date
2008 Year 10 Month 01 Day
Last follow-up date
2016 Year 07 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 10 Month 17 Day
Last modified on
2008 Year 10 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001686

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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