Prospective multicenter non-randomized parallel-group comparative study to evaluate the efficacy of P-CAB/AMPC/MNZ 7 day triple therapy as first line eradication of CAM-resistant Helicobacter pylori: superiority study compared to P-CAB/AMPC/CAM, non-inferiority study compared to PPI/AMPC/MNZ, superiority study compared to PPI/AMPC/CAM

Prospective multicenter non-randomized parallel-group comparative study to evaluate the efficacy of P-CAB/AMPC/MNZ 7 day triple therapy as first line eradication of CAM-resistant Helicobacter pylori: superiority study compared to P-CAB/AMPC/CAM, non-inferiority study compared to PPI/AMPC/MNZ, superiority study compared to PPI/AMPC/CAM - P-CAB/AMPC/MNZ 7 day triple therapy as first line eradication of CAM-resistant Helicobacter pylori

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000022920

Enrollment

189

Registered

2016-06-28

Start date

2016-06-28

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 1 week Vonoprazan 20mg bid Amoxicillin 750mg bid Clarithromycin 200mg or 400mg bid 1 week Lansoprazole 30mg, Rabeprazole 10mg,

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: A patient with CAM-resistant H. pylori infection A patient who give a written informed consent

Exclusion criteria

Exclusion criteria: Past history of taking eradication therapy. Pregnancy or lactation. Past history of allergy for the drugs used in this therapy. A patient with brain and spinal cord disease. A patient with infectious mononucleosis. Severe liver dysfunction, severe renal dysfunction, severe heart dysfunction. Patients who are disqualified for the study by physicians.

Design outcomes

Primary

Measure	Time frame
Comparison of eradication rate between P-CAB/AMPC/MNZ and P-CAB/AMPC/CAM or PPI/AMPC/MNZ or PPI/AMPC/CAM. Success of eradication was assessed by urea breath test or H. pylori stool antigen test more than 6 weeks after treatment.	—

Secondary

Measure	Time frame
Safety evaluated by side effects questionnaire filled by patients during the therapy.	—

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