Efficacy and safety of dual therapy containing vonopranzan and amoxicillin as first line Helicobacter pylori eradication: a randomized, non-inferiority trial

Efficacy and safety of dual therapy containing vonopranzan and amoxicillin as first line Helicobacter pylori eradication: a randomized, non-inferiority trial - Vonoprazan-based dual therapy for first line H. pylori eradication

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000034140

Enrollment

320

Registered

2018-09-14

Start date

2018-09-14

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

Interventions

vonoprazan 20 mg twice/day and amoxicillin 750 mg twice/day for 7 days. vonoprazan 20 mg twice/day, amoxicillin 750 mg twice/day, and clarithromycin 200 mg twice/day for 7 days.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients will be positive for H. pylori which confirmed through culture of biopsy specimens. 2) Aged 20-79 years 3) Performance Status (ECOG) 0, 1, or 2 4) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Allergy to vonoprazan, amoxicillin, or clarithromycin 2) A history of receiving H. pylori eradication therapy 3) A history of gastric surgery 4) Using PPI 5) Using antibiotics 6) Using steroid 7) Pregnancy 8) Breast-feeding 9) Lack of informed consent 10) Others

Design outcomes

Primary

Measure	Time frame
The primary outcome of this study is H. pylori eradication rates in the dual therapy and the standard triple therapy groups. Eradication success is evaluated at least 4 weeks after the treatment period using the urea breath test with success defined as a result of < 2.5 permil.	—

Secondary

Measure	Time frame
1. The rate of adverse events 2. The rate of treatment or intervention for adverse events 3. Number of defecation 4. Stool forms 5. Compliance of taking drugs 6. Eradication rate in patients who have H. pylori with antibiotic resistance 7. Oral and gut microbiota proliferation	—

Countries

Japan

Contacts

Public ContactSho Suzuki

Nihon University School of Medicine Division of Gastroenterology and Hepatology, Department of Medicine

s.sho.salubriter.mail@gmail.com03-3293-1711

Outcome results

None listed

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