UMIN-CTR Clinical Trial

Basic information
Public title	First-line Helicobacter pylori Eradication with Vonoprazan, Amoxicillin, and Metronidazole for university students
Acronym	First-line HP eradication with VAM regimen for university students
Scientific Title	First-line Helicobacter pylori Eradication with Vonoprazan, Amoxicillin, and Metronidazole for university students
Scientific Title:Acronym	First-line HP eradication with VAM regimen for university students
Region	Japan

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

Objectives
Narrative objectives1	To assess the efficacy and safety of first-line Helicobacter pylori eradication with Vonoprazan, Amoxicillin, and Metronidazole for university students.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Eradication rate assessed by stool antigen test of Helicobacter pylori more than 8 weeks after treatment
Key secondary outcomes	Adverse event evaluated by side effect questionnaire filled by patients

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Vonoprazan 20mg bid Amoxicillin 750mg bid Metronidazole 250mg bid 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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) Yokohama City University student or Yokohama National University student (2) Urine Helicobacter pylori enzyme-linked immunosorbent assay (u-HpELISA) positive patient which was performed as clinical study: Urine Helicobacter pylori enzyme-linked immunosorbent assay for university student at the health examination and questionnaire based survey(UMIN000032115). (3) A patient who can perform stool antigen test of Helicobacter pylori after 8 weeks from treatment completion. (4)Within 5 months after result notification of u-HpELISA. (5)A patient who give a written informed consent.
Key exclusion criteria	(1) A patient with history of Helicobacter pylori eradication. (2) Patients allergic to penicillin. (3) Past history of allergy for the drugs used in this study. (4) Pregnancy. (5) Lactation. (6) A patient with brain and spinal cord disease. (7) A patient with infectious mononucleosis. (8) Severe liver dysfunction, severe renal dysfunction, severe heart dysfunction. (9) Patient who is disqualified for the study by physicians.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Shin Middle name Last name Maeda
Organization	Yokohama City University Hospital
Division name	Gastroenterology
Zip code	236-0004
Address	Fukuura3-9, Kanazawa, Yokohama, Kanagawa, Japan
TEL	045-787-2326
Email	smaeda@med.yokohama-cu.ac.jp

Public contact
Name of contact person	1st name Soichiro Middle name Last name Sue
Organization	Yokohama City University Hospital
Division name	Gastroenterology
Zip code	236-0004
Address	Fukuura3-9, Kanazawa, Yokohama, Kanagawa, Japan
TEL	045-787-2326
Homepage URL
Email	ssue@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University Hospital
Institute
Department

Funding Source
Organization	Kanagawa prefecture and Yokohama City University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Yokohama National University, Yokohama Hodogaya Central Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Yokohama City University Ethics committee
Address	Fukuura 3-9, Kanazawa, Yokohama, Kanagawa, Japan
Tel	045-370-7627
Email	rinri@yokohama-cu.ac.jp

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	2018 Year 04 Month 05 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	2018 Year 02 Month 14 Day
Date of IRB	2018 Year 03 Month 05 Day
Anticipated trial start date	2018 Year 04 Month 19 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 04 Month 04 Day
Last modified on	2020 Year 02 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036621