The efficacy and safety of third line H. pylori eradication therapy with sitafloxacin, metronidazole and PPI

The efficacy and safety of third line H. pylori eradication therapy with sitafloxacin, metronidazole and PPI - The efficacy of third line H. pylori eradication therapy with sitafloxacin, metronidazole and PPI

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000013195

Enrollment

100

Registered

2014-02-18

Start date

2014-02-18

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 or penicillin-allergic patients

Interventions

esomeprazole 40mg,b.i.d., metronidazole 500mg b.i.d., q.i.d., sitafloxacin 200 mg, b.i.d.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: H. pylori-positve patients after the 2nd line H. pylori eradication therapy or penicillin-allergic patients

Exclusion criteria

Exclusion criteria: 1. Patients with allergy for quinolones 2. Patients with allergy for PPIs 3. Patients with severe liver injury and/or severe renal damage 4. Pregnancy or possible pregnancy 5. Patients who were recognized as inappropriate for entry

Design outcomes

Primary

Measure	Time frame
The efficacy of H. pylori eradication	—

Secondary

Measure	Time frame
adverse events MIC of STFX,MNZ, gyaA mutation	—

Countries

Japan

Contacts

Public ContactHideki Mori

Keio University School of Medicine Division of Gastroenterology and Hepatology, Department of Internal Medicine

koyamaru2002@yahoo.co.jp070-6946-1119

Outcome results

None listed

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