Clinical Trial

Clinical Trial to Evaluate the Efficacy of Probit-Based Triple Therapy for Helicobacter Pylori Eradication

Not Yet Recruiting Phase 4
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Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-08-04.
Trial Details
NCT Number NCT07115173
Lead Sponsor Samsung Medical Center
Conditions Helicobacter Infection
Enrollment 103 participants
Start Date 2025-12-01
Primary Completion 2027-06-01 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-08-14