A Phase 4 interventional study of This study aims to evaluate the efficacy and safety of a 14-day triple therapy regimen consisting of Zastaprazan 20 mg, clarithromycin, and amoxicillin for the eradication of Helicobacter pylori. in Helicobacter Infection, sponsored by Samsung Medical Center. Not yet recruiting. Open to participants aged 19 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-08-14.
Sponsored by Samsung Medical Center · Phase 4, Interventional, and Treatment
This is a single-center, open-label, non-randomized, single-arm clinical study. Eligible participants who provide written informed consent will undergo screening based on inclusion/exclusion criteria. Enrolled subjects will receive the investigational treatment: Zastaprazan 20 mg (twice daily), clarithromycin 500 mg (twice daily), and amoxicillin 1000 mg (three times daily) for 14 days. Four to eight weeks after completing the therapy, participants will return for a urea breath test to assess H. pylori eradication. The study will also investigate the efficacy of this therapy in clarithromycin-resistant patients to indirectly assess the potential of a dual regimen using Zastaprazan and amoxicillin.
Exclusion Criteria:
Drug: This study aims to evaluate the efficacy and safety of a 14-day triple therapy regimen consisting of Zastaprazan 20 mg, clarithromycin, and amoxicillin for the eradication of Helicobacter pylori.
This study aims to evaluate the efficacy and safety of a 14-day triple therapy regimen consisting of Zastaprazan 20 mg, clarithromycin, and amoxicillin for the eradication of Helicobacter pylori.
Eradication rate
Efficacy of H. pylori eradication therapy. confirmed by negative UBT test
Time frame: 4 to 8 weeks
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Samsung Medical Center