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A randomized controlled trial comparing Vonoprazan, Amoxicillin, Metronidazole triple therapy and Rabeprazole, Amoxicillin, Metronidazole triple therapy as a second-line eradication of Helicobacter pylori

A randomized controlled trial comparing Vonoprazan, Amoxicillin, Metronidazole triple therapy and Rabeprazole, Amoxicillin, Metronidazole triple therapy as a second-line eradication of Helicobacter pylori - RCT comparing VAM and RAM HP eradication as second-line

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000025801
Enrollment
80
Registered
2017-01-24
Start date
2017-01-24
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 20mg bid Amoxicillin 750mg bid Metronidazole 250mg bid 7 days Rabeprazole 10mg bid Amoxicillin 750mg bid Metronidazole 250mg bid 7 days

Sponsors

Yokohama City University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: A patient who failed first-line eradication therapy with Vonoprazan, Amoxicillin and Clarithromycin. A patient who can do eradication therapy as second time(second-line) in this study. A patient who was diagnosed for Helicobacter pylori infection and failure of first-line eradication by urea breath test or Helicobacter pylori stool antigen test. A patient who can perform urea breath test after 8 weeks from treatment completion. A patient who give a written informed consent.

Exclusion criteria

Exclusion criteria: A patient who has eradication history except triple therapy with Vonoprazan, Amoxicillin and Clarithromycin. Pregnancy or lactation. Past history of allergy for the drugs used in this study. A patient with brain and spinal cord disease. A patient with infectious mononucleosis. Severe liver dysfunction, severe renal dysfunction, severe heart dysfunction. Patient who is disqualified for the study by physicians.

Design outcomes

Primary

MeasureTime frame
Eradication rate assessed by urea breath test more than 8 weeks after treatment

Secondary

MeasureTime frame
Safety evaluated by side effect questionnaire filled by patients

Countries

Japan

Contacts

Public ContactSoichiro Sue

Yokohama City University Hospital Gastroenterology

ssue@yokohama-cu.ac.jp045-261-5656

Outcome results

None listed

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