UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032351
Receipt number R000036883
Scientific Title A retrospective study in clinical course of Heicobacter pylori eradication therapy
Date of disclosure of the study information 2018/04/25
Last modified on 2018/10/22 11:30:56

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Basic information

Public title

A retrospective study in clinical course of Heicobacter pylori eradication therapy

Acronym

H. pylori eradication therapy

Scientific Title

A retrospective study in clinical course of Heicobacter pylori eradication therapy

Scientific Title:Acronym

H. pylori eradication therapy

Region

Japan


Condition

Condition

H.pylori infected patients

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aims are to compare success rates in H. pylori eradication therapies.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Primary outcome is non-inferiority of vonoprazan-based therapy for other regimens including PPI-based therapy.

Key secondary outcomes



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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

patients who received eradication therapy(vonoprazan, PPI)

Key exclusion criteria

patient who refused the therapy

Target sample size

427


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroki Tanabe

Organization

International University of Health and Welfare Hospital

Division name

Department of Gastroenterology

Zip code


Address

537-3 Iguchi Nasushiobara, Tochigi

TEL

+81-287393060

Email

tant@asahikawa-med.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroki Tanabe

Organization

International University of Health and Welfare Hospital

Division name

Department of Gastroenterology

Zip code


Address

537-3 Iguchi Nasushiobara, Tochigi

TEL

+81-287393060

Homepage URL


Email

tant@asahikawa-med.ac.jp


Sponsor or person

Institute

Asahikawa Medical University

Institute

Department

Personal name



Funding Source

Organization

Asahikawa Medical University

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

2018 Year 04 Month 25 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

https://doi.org/10.1186/s12941-018-0281-x

Number of participants that the trial has enrolled


Results

Vonoprazan-based triple therapy was effective as susceptibility-guided triple therapy for H. pylori eradication.

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

Main results already published

Date of protocol fixation

2017 Year 04 Month 01 Day

Date of IRB


Anticipated trial start date

2017 Year 04 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete

2018 Year 04 Month 01 Day

Date analysis concluded

2018 Year 04 Month 25 Day


Other

Other related information

observational study


Management information

Registered date

2018 Year 04 Month 23 Day

Last modified on

2018 Year 10 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036883


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name