UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000046308
Receipt number R000049723
Scientific Title long year trend of successfully Helicobacter pylori eradicated patients by using vonoprazan: Single center cohort study
Date of disclosure of the study information 2021/12/07
Last modified on 2023/07/08 15:03:37

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Basic information

Public title

long year trend of successfully Helicobacter pylori eradicated patients by using vonoprazan: Single center cohort study

Acronym

long year trend of eradicated patients

Scientific Title

long year trend of successfully Helicobacter pylori eradicated patients by using vonoprazan: Single center cohort study

Scientific Title:Acronym

long year trend of eradicated patients

Region

Japan


Condition

Condition

Chronic gastritis

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to describe epidemiological information on post-eradication trends in patients treated with vonoprazan for H. pylori eradication.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

long term incidence of gastric cancer and mortality

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

20 years-old <=

Age-upper limit

100 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients who underwent H.p. eradication with vonoprazan between January 2015 and December 2017 in our hospital will be included.

Key exclusion criteria

Patients who are judged by the principal investigator to be unsuitable as subjects or whose consent cannot be obtained.

Target sample size

1000


Research contact person

Name of lead principal investigator

1st name Takeshi
Middle name
Last name Yasuda

Organization

Asahi University Hospital

Division name

Department of gastroenterology

Zip code

500-8523

Address

3-23, Gifu city, Hashimoto

TEL

058(253)8001

Email

t-yasuda@koto.kpu-m.ac.jp


Public contact

Name of contact person

1st name Takeshi
Middle name
Last name Yasuda

Organization

Asahi University Hospital

Division name

Department of gastroenterology

Zip code

500-8523

Address

3-23, Gifu city, Hashimoto

TEL

058(253)8001

Homepage URL


Email

t-yasuda@koto.kpu-m.ac.jp


Sponsor or person

Institute

Asahi University

Institute

Department

Personal name



Funding Source

Organization

Asahi University

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

Asahi University Hospital

Address

3-23, Gifu city, Hashimoto

Tel

058(253)8001

Email

t-yasuda@koto.kpu-m.ac.jp


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

朝日大学病院


Other administrative information

Date of disclosure of the study information

2021 Year 12 Month 07 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled

934

Results



Results date posted

2022 Year 06 Month 23 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

The average age was 57.8, Sex Male: Female=535:399, Background mucosa; closed type: open type=365: 551 (unknown,:18)).

Participant flow


Adverse events

Minor side effects (e.g. rash, diarrhea, et al) occurred in 3.0% patients.

Outcome measures

Among background factors, age, atrophic border was related to the eradication rate. 12 GCs was found after eradication and all cases were stage IA. The 3year and 5year incidence rate was 0.38%, 1.92% respectively. The GCs developed 40.5. months after eradication. 12 people died during the observed period.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2018 Year 05 Month 25 Day

Date of IRB

2018 Year 05 Month 25 Day

Anticipated trial start date

2018 Year 05 Month 25 Day

Last follow-up date

2030 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

retrospective cohort study


Management information

Registered date

2021 Year 12 Month 07 Day

Last modified on

2023 Year 07 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049723


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name