UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of Vonoprazan-based triple theary for eradication of helicobacter pylori
Title of the study (Brief title)	Eradication with Vonoprazan
Region	Japan

Condition
Condition	gastritis with helicobacter pylori infection
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluate Vonoprazan-based triple thearpy for helicobacter pylori compare to PPI-based triple thearpy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Success rate of the eradication therapy after one month later by urea breath test
Key secondary outcomes	Mortality and morbidity of the eradication therapy

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Vonoprazan 40mg/day 7days
Interventions/Control_2	Proton pump inhibitor
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	patients with helicobacter pylori infection
Key exclusion criteria	none
Target sample size	2000

Research contact person
Name of lead principal investigator	Ryuzo Murai
Organization	Onaka Clinic
Division name	Department of gastroenterology
Address	12-12 Asahicho Hachiouji-shi Tokyo JAPAN
TEL	042-644-1127
Email	murai@m-onaka.com

Public contact
Name of contact person	Ryuzo Murai
Organization	Onaka Clinic
Division name	Department of gastroenterology
Address	12-12 Asahicho Hachiouji-shi Tokyo JAPAN
TEL	042-644-1127
Homepage URL
Email	murai@m-onaka.com

Sponsor
Institute	Onaka Clinic
Institute
Department

Funding Source
Organization	Onaka Clinic
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 07 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 02 Month 28 Day
Anticipated trial start date	2015 Year 02 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results	The success rate of vonoprazan-based triple thearpy was 91.7% at the primary eradication compare to 80.9% with PPI. It is significant better result.
Other related information

Management information
Registered date	2016 Year 06 Month 22 Day
Last modified on	2018 Year 10 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026328