臨床研究等提出・公開システム

Japanese

Date of registration	Sept. 23, 2020
Last modified on	Aug. 27, 2025
Trial ID	jRCTs031200128

Scientific Title	Multicenter randomized trial of vonoprazan and high dose amoxicillin dual therapy versus triple therapy with clarithromycin for Helicobacter pylori
Public Title	RCT of Vonoprazan and high dose Amoxicillin eradication

Contact for Scientific Queries	Name	Sue Soichiro
	Affiliation	Yokohama City University Hospital
	Address	Fukuura3-9, Kanazawa, Yokohama, Kanagawa
	Telephone	+81-45-787-2800
	E-mail	ssue@yokohama-cu.ac.jp
Contact for Public Queries	Name	Sue Soichiro
	Affiliation	Yokohama City University Hospital
	Address	Fukuura3-9, Kanazawa, Yokohama, Kanagawa
	Telephone	+81-45-787-2800
	E-mail	ssue@yokohama-cu.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Nov. 01, 2020
Actual date of first enrollment		Nov. 04, 2020
Target sample size		120
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	active control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Patients infected with Helicobacter pylori. Positive patients by Urea breath test, stool Helicobacter pylori antigen test, Helicobacter pylori culture, anti-Helicobacter pylori antibody test (blood), rapid urease test (biopsy sample), or histological diagnosis (biopsy sample) are treat with infected. Patients who give a written informed consent.
	Exclusion Criteria	Patients who have Helicobacter pylori eradication history. Pregnancy or lactation. Past history of allergy for the drugs used in this therapy. Patients with infectious mononucleosis. Patients using atazanavir, rilpivirine, pimozide, ergotamine, suvorexant, lomitapide mesylate, tadalafil, ticagrelor, ibrutinib, asuna previr, ivavradine, venetoclax, lurasidone hydrochloride, anamorelin hydrochloride, finerenone, or isavuconazonium sulfate. Patients using colchicine with liver dysfunction or renal dysfunction. Severe liver dysfunction, severe renal dysfunction, severe heart dysfunction. Patients who are disqualified for the study by phyusicians.
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Helicobacter pylori infection
Intervention(s)		(1) Dual therapy Vonoprazan (20mg) given on twice daily and Amoxicillin (500mg) given on hour times daily For 7 days (2) Triple therapy Vonoprazan (20mg), amoxicillin (500mg), and clarithromycin (400mg) given on twice daily for 7days
Health Condition(s) Keyword		Helicobacter pylori
Intervention(s) Keyword		Helicobacter pylori eradication therapy
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Eradication rate (PPS)
Secondary Outcome(s)		(1) Eradication rate (PPS) (2) Safety

Primary Sponsor

Primary Sponsor

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	Yokohama City University
Secondary Sponsor

Name of Certified Review Board	Yokohama City University Certified Institutional Review Board
Address	3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Kanagawa
Telephone	+81-45-370-7627
E-Mail	ycu_crb@yokohama-cu.ac.jp
Approval Status	Approval
Date of approval	Sept. 10, 2020

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
13	Aug. 27, 2025	(this page)	Changes
12	Oct. 11, 2024	Detail	Changes
11	April. 04, 2024	Detail	Changes
10	Oct. 11, 2023	Detail	Changes
9	July. 11, 2023	Detail	Changes
8	July. 11, 2023	Detail	Changes
7	Nov. 18, 2022	Detail	Changes
6	Nov. 18, 2022	Detail	Changes
5	June. 13, 2022	Detail	Changes
4	Oct. 12, 2021	Detail	Changes
3	Dec. 10, 2020	Detail	Changes
2	Oct. 16, 2020	Detail	Changes
1	Sept. 23, 2020	Detail

List of change history