UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021824
Receipt number R000024908
Scientific Title The efficacy and safety of Helicobacter pylori eradication therapy using vonoprazan
Date of disclosure of the study information 2016/04/07
Last modified on 2019/02/17 16:01:08

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

The efficacy and safety of Helicobacter pylori eradication therapy using vonoprazan

Acronym

The efficacy and safety of H. pylori eradication therapy using vonoprazan

Scientific Title

The efficacy and safety of Helicobacter pylori eradication therapy using vonoprazan

Scientific Title:Acronym

The efficacy and safety of H. pylori eradication therapy using vonoprazan

Region

Japan


Condition

Condition

Helicobacter pylori infection

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of Helicobacter pylori eradication therapy using vonoprazan

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The rate of Helicobacter pylori eradication using 1st line triple therapy and 2nd line triple therapy

Key secondary outcomes

The rate of side effects


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

1st line triple therapy)
Vonoprazan 20mg bid
Amoxicillin 750mg bid
Clarithromycin 200mg bid
daily for 7 days

2nd line triple therapy)
Vonoprazan 20mg bid
Amoxicillin 750mg bid
Metronidazole 250mg bid
daily for 7 days

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

15 years-old <=

Age-upper limit

90 years-old >=

Gender

Male and Female

Key inclusion criteria

Cases with Helicobacter pylori infection.
Cases with written and oral informed consent.

Key exclusion criteria

Past history of allergy for these medications, Vonoprazan, Amoxicillin, Clarithromycin, and Metronidazole used in this therapy.

Target sample size

800


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hattori Masashi

Organization

Medical corporation Yamashita Hospital

Division name

Gastroenterology

Zip code


Address

1-3-5, Nakamachi, Ichinomiya

TEL

0586-45-4511

Email

m.hattori@yamashita.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Esaki Masaya

Organization

Medical corporation Yamashita Hospital

Division name

Gastroenterology

Zip code


Address

1-3-5, Nakamachi, Ichinomiya

TEL

0586-45-4511

Homepage URL


Email

b.b.player6089@gmail.com


Sponsor or person

Institute

Medical corporation Yamashita Hospital

Institute

Department

Personal name



Funding Source

Organization

Medical corporation Yamashita Hospital

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

2016 Year 04 Month 07 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

Completed

Date of protocol fixation

2016 Year 03 Month 29 Day

Date of IRB


Anticipated trial start date

2016 Year 03 Month 29 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 04 Month 07 Day

Last modified on

2019 Year 02 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024908


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name