Double blind-randomized controlled trial for the efficacy of third line H. pylori eradication therapy between refabutin-including 10 days and 14 days regimen

Double blind-randomized controlled trial for the efficacy of third line H. pylori eradication therapy between refabutin-including 10 days and 14 days regimen - Double blind-randomized controlled trial for the efficacy of third line H. pylori eradication therapy

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000011963

Enrollment

170

Registered

2013-10-04

Start date

2013-10-04

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

H. pylori-positve patients after the 2nd line eradication failure

Interventions

esomeprazole 80mg, q.i.d., amoxicillin 2.0g, q.i.d., rifabutin 300mg, o.d. 10 days esomeprazole 80mg, q.i.d., amoxicillin 2.0g, q.i.d., rifabutin 300mg, o.d. 14 days

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: H. pylori-positve patients after the 2nd line H. pylori eradication therapy with informed consent

Exclusion criteria

Exclusion criteria: 1. Patients with allergy for rifamycins 2. Patients with past histry of tuberculosis or nontuberculous mycobacterial infection 3. Patients with allergy for PPIs 4. Patients with allergy for penicillin 5. Patients with severe liver injury and/or severe renal damage 6. Pregnancy or possible pregnancy 7. Patients who are taking voriconazole 8. Patients with uveitis 9. Patients who were recognized as inappropriate for entry

Design outcomes

Primary

Measure	Time frame
The efficacy of H. pylori eradication	—

Countries

Japan

Contacts

Public ContactHidekazu Suzuki

Keio University School of Medicine Department of Internal Medicine

masaoka@z6.keio.jp070-6946-1119

Outcome results

None listed

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