Overview

Tegoprazan Plus Amoxicillin BID vs TID Regimens for H. Pylori EradicationFrequency Adjusted Same-dose Therapy for H. Pylori

Status:
NOT_YET_RECRUITING

Trial end date:
2026-12-31

Target enrollment:

Participant gender:

Summary

This study is designed to evaluate two different tegoprazan-based dual therapy regimens for the treatment of Helicobacter pylori (H. pylori) infection. All participants will receive tegoprazan 50 mg twice daily for 14 days, combined with one of two amoxicillin dosing schedules that contain the same total daily dose of 3 grams of amoxicillin. One group will receive amoxicillin 1 gram three times daily (TID), which is the standard regimen. The other group will receive amoxicillin 1.5 grams twice daily (BID), an alternative schedule that may improve convenience and treatment adherence while maintaining the same total daily antibiotic amount. A total of 240 adults with confirmed H. pylori infection will be randomly assigned to one of the two treatment groups. The main goal of the study is to compare the H. pylori eradication rates between the two regimens. Eradication will be assessed 4 to 8 weeks after completing therapy using a C-urea breath test. Safety, tolerability, and medication adherence will also be monitored.

Phase:

PHASE4

Details

Lead Sponsor:

First People's Hospital of Hangzhou

Treatments:

Amoxicillin
BID protein, human
tegoprazan