Double blind-randomized controlled trial for the efficacy of third line H. pylori eradication therapy between sitafloxacin-including regimen and sitafloxacin and metronidazole-including regimen

Double blind-randomized controlled trial for the efficacy of third line H. pylori eradication therapy between sitafloxacin-including regimen and sitafloxacin and metronidazole-including 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-UMIN000006483

Enrollment

200

Registered

2012-11-01

Start date

2011-11-01

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 40mg, q.i.d., amoxicillin 2.0g, q.i.d., sitafloxacin 200 mg, b.i.d. esomeprazole 40mg, q.i.d., metronidazole 500mg, 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 with informed consent

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
MIC of STFX, FIC index of the interaction between STFX and MNZ, gyaA mutation	—

Countries

Japan

Contacts

Public ContactHidekazu Suzuki

Keio University School of Medicine Department of Internal Medicine

hsuzuki@a6.keio.jp070-6946-1119

Outcome results

None listed

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