drugset / Trial / NCT07115173

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

NCT07115173

Phase 4 Not yet recruiting 103 enrolled Samsung Medical Center
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2025-12-01
Primary completion
2027-06-01
Completion
2027-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Amoxicillin Other / unclassified 1000 mg
Subject Clarithromycin Small molecule 500 mg
Subject Zastaprazan Unknown 20 mg