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RCT of Vonoprazan and high dose Amoxicillin eradication

Multicenter randomized trial of vonoprazan and high dose amoxicillin dual therapy versus triple therapy with clarithromycin for Helicobacter pylori

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031200128
Enrollment
120
Registered
2020-09-23
Start date
2020-11-04
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter pylori infection Helicobacter pylori

Interventions

(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)

Sponsors

Sue Soichiro
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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 tartrate/anhydrous caffeine/isopropylantipyrine, dihydroergotamine mesylate, suvorexant, daridorexant hydrochloride, vornorexant hydrate, lomitapide mesylate, tadalafil (Adcirca), ticagrelor, ibrutinib, ivabradine hydrochloride, venetoclax (during the dose titration phase), lurasidone hydrochloride, anamorelin hydrochloride, finerenone, isavuconazonium sulfate, voclosporin, or mavacamten. 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.

Design outcomes

Primary

MeasureTime frame
Eradication rate (PPS)

Secondary

MeasureTime frame
(1) Eradication rate (PPS) (2) Safety

Contacts

Public ContactSoichiro Sue

Yokohama City University Hospital

ssue@yokohama-cu.ac.jp+81-45-787-2800

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026