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NOT YET RECRUITING
NCT07242443
PHASE4

Tegoprazan Plus Amoxicillin BID vs TID Regimens for H. Pylori Eradication(Frequency Adjusted Same-dose Therapy for H. Pylori)

Sponsor: First People's Hospital of Hangzhou

View on ClinicalTrials.gov

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 ¹³C-urea breath test. Safety, tolerability, and medication adherence will also be monitored.

Official title: A Randomized Controlled Trial Comparing Tegoprazan 50 mg BID Combined With Amoxicillin 1 g TID Versus Tegoprazan 50 mg BID Combined With Amoxicillin 1.5 g BID for the Eradication of Helicobacter Pylori

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

240

Start Date

2025-11-20

Completion Date

2026-12-31

Last Updated

2025-11-21

Healthy Volunteers

No

Interventions

DRUG

Tegoprazan 50 mg

Tegoprazan 50 mg administered orally twice daily (BID) for 14 days.

DRUG

Amoxicillin 1 g TID

Amoxicillin 1 gram administered orally three times daily (TID) for 14 days.

DRUG

Amoxicillin 1.5 g BID

Amoxicillin 1.5 grams administered orally twice daily (BID) for 14 days.

Locations (1)

Hangzhou First People's Hospital

Hangzhou, Zhejiang, China