UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effective of the triple therapy for clarithromycin-resistant Helicobacter pylori using Vonoprazan,AMPC,MNZ.
Title of the study (Brief title)	Eradication therapy for CAM-resistant Helicobacter pylori.
Region	Japan

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

Objectives
Narrative objectives1	Varify the effecacy of first line triple therapy for the clarithromycin-resistant Helicobacter pylori using vonoprazan, amoxicillin and metronidazole.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	eradication rate
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Helicobacter pylori infected patient
Key exclusion criteria	Penicillin allergy
Target sample size	200

Research contact person
Name of lead principal investigator	Hisatsugu Noda
Organization	Aichi medical university
Division name	gastroenterology
Address	1-1 yazakokarimata Nagakute city Aichi
TEL	0561-62-3311
Email	bisaipan@aichi-med-u.ac.jp

Public contact
Name of contact person	Hisatsugu Noda
Organization	Aichi medical university
Division name	gastroenterology
Address	1-1 yazakokarimata Nagakute city Aichi
TEL	0561-62-3311
Homepage URL
Email	bisaipan@aichi-med-u.ac.jp

Sponsor
Institute	Aichi medical university
Institute
Department

Funding Source
Organization	Aichi medical university
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 03 Month 10 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 03 Month 08 Day
Anticipated trial start date	2016 Year 03 Month 10 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	Cohort study All the members who were equal to criteria for selection in the patients who consulted our institution in March, 2019 from April, 2016

Management information
Registered date	2016 Year 03 Month 10 Day
Last modified on	2017 Year 02 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024674