UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The efficacy and safety of Helicobacter pylori eradication therapy using vonoprazan
Title of the study (Brief title)	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	Hattori Masashi
Organization	Medical corporation Yamashita Hospital
Division name	Gastroenterology
Address	1-3-5, Nakamachi, Ichinomiya
TEL	0586-45-4511
Email	m.hattori@yamashita.or.jp

Public contact
Name of contact person	Esaki Masaya
Organization	Medical corporation Yamashita Hospital
Division name	Gastroenterology
Address	1-3-5, Nakamachi, Ichinomiya
TEL	0586-45-4511
Homepage URL
Email	b.b.player6089@gmail.com

Sponsor
Institute	Medical corporation Yamashita Hospital
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 03 Month 29 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024908