UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of vonoprazan-based dual therapy with amoxicillin and the triple therapy with amoxicillin and clarithromycin for H. Pylori Eradication
Title of the study (Brief title)	Comparison of Vonoprazan-based Dual and Triple Therapies for H. Pylori Eradication
Region	Japan

Condition
Condition	H. pylori infection
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the eradication rate with the dual therapy with vonoprazan 20 mg bid and amoxicillin 500 mg tid with those with the triple therapy with vonoprazan 20 mg bid, amoxicillin 750 mg bid and metronidazole 250 mg bid for 1 week.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	eradication rates of H. pylori
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Triple therapy with vonoprazan 20 mg bid, amoxicillin 750 mg bid and clarithromycin 200 mg or metronidazole 250 mg bid for 1 week.
Interventions/Control_2	The dual therapy with vonoprazan 20 mg bid and amoxicillin 500 mg tid for 1 week
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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients infected with H. pylori Patients who agree to participate to the study
Key exclusion criteria	Patients who do not agree to participate to the study Patients who had ever failed in eradication of H. pylori no less than 2 times. Patients who are allergic to any of drugs used in this study Patients who are considered inappropriate to participate to the study by the doctor
Target sample size	100

Research contact person
Name of lead principal investigator	Takahisa Furuta
Organization	Hamamatsu University School of Medicine
Division name	Center for Clinical Research
Address	1-20-1, Handayama, HigashiKu, Hamamatsu, 431-3192, Japan
TEL	053-435-2850
Email	furuta@hama-med.ac.jp

Public contact
Name of contact person	Takahisa Furuta
Organization	Hamamatsu University School of Medicine
Division name	Center for Clinical Research
Address	1-20-1, Handayama, HigashiKu, Hamamatsu, 431-3192, Japan
TEL	053-435-2850
Homepage URL
Email	furuta@hama-med.ac.jp

Sponsor
Institute	Ministry of health, labor and welfare
Institute
Department

Funding Source
Organization	Self funding
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	R15-006
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	浜松医科大学付属病院

Other administrative information
Date of disclosure of the study information	2016 Year 07 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 05 Month 01 Day
Anticipated trial start date	2016 Year 07 Month 01 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 06 Month 28 Day
Last modified on	2017 Year 12 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026415