UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001434
Receipt number 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 09:50:08

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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 or person

Institute

Department of Gastroenterology
University of Tokyo

Institute

Department

Personal name



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

Value
https://center6.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