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NOT YET RECRUITING
NCT07115173
PHASE4

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

Sponsor: Samsung Medical Center

View on ClinicalTrials.gov

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.

Official title: A Single-Center, Single-Arm Clinical Trial to Evaluate the Efficacy of Probit-Based Triple Therapy for Helicobacter Pylori Eradication

Key Details

Gender

All

Age Range

19 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

103

Start Date

2025-12-01

Completion Date

2027-12-31

Last Updated

2025-08-14

Healthy Volunteers

No

Interventions

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.