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Recruitment status
Unique ID issued by UMIN UMIN000001938
Receipt No. R000002359
Scientific Title Clinical trial on efficacy of eradication therapy for Helicobacter pylori infection to improve gastric atrophy.
Date of disclosure of the study information 2009/05/02
Last modified on 2009/05/02

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Basic information
Public title Clinical trial on efficacy of eradication therapy for Helicobacter pylori infection to improve gastric atrophy.
Acronym Helicobacter eradication for gastric atrophy improvement.
Scientific Title Clinical trial on efficacy of eradication therapy for Helicobacter pylori infection to improve gastric atrophy.
Scientific Title:Acronym Helicobacter eradication for gastric atrophy improvement.
Region
Japan

Condition
Condition Patients of atrophic gastritis with H. pylori infection
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate efficacy of Helicobacter eradication for improvement of gastric atrophy in the pateints with atrophic gastritis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes pathological examination of gastric atrophy
Key secondary outcomes

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 for Helicobacter 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
20 years-old <=
Age-upper limit
75 years-old >=
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 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shin Maeda
Organization University of Tokyo
Division name Department of Gastroenterology
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
Email

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

Sponsor
Institute Department of Gastroenterology
The Tokyo University hospital
Institute
Department

Funding Source
Organization Department of Gastroenterology
The Tokyo University hospital
Organization
Division
Category of Funding Organization
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
2009 Year 05 Month 02 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
2009 Year 04 Month 09 Day
Date of IRB
Anticipated trial start date
2009 Year 05 Month 01 Day
Last follow-up date
2014 Year 06 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
2009 Year 05 Month 02 Day
Last modified on
2009 Year 05 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002359

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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