None listed
Conditions
Interventions
Drug : This study is single-center, open-label, non-randomized, and single-arm study. Only those who voluntarily agreed in writing are eligible for clinical trials based on the selection/exclusion cri
Sponsors
Samsung Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -confirmed H. pylori? positive result in urea breath test or urease test results -diagnosed with diseases such as chronic atrophic gastritis or peptic ulcer requiring eradication therapy -eligible for endoscopic biopsy and who consent to specimen collection and clarithromycin PCR testing through biopsy
Exclusion criteria
Exclusion criteria: -Individuals with a history of H. pylori? eradication therapy before study participation -Individuals with evidence of acute upper gastrointestinal bleeding -Individuals currently taking contraindicated medications for the study drug -Individuals with a history of P-CAB, PPI, or H2 receptor blocker use within 2 weeks prior to study drug administration date, or who require the use of P-CAB, PPI, or H2 receptor blockers other than the study drug during the trial period until study completion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| H. pylori eradication rate confirmed by urea breath test performed 4 to 8 weeks after completion of the IP;Safety assessment variables: concomitant medications, adverse events, laboratory tests, electrocardiograms, physical examinations, and vital signs. | — |
Secondary
| Measure | Time frame |
|---|---|
| Eradication rate according to the presence or absence of clarithromycin resistance in H. pylori | — |
Countries
Korea, Republic of
Contacts
Public ContactSooJung Kim
Samsung Medical Center
Outcome results
None listed