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

NCT07242443 · tracked via the Priya Life Science China tracker

Sponsor

First People's Hospital of Hangzhou

Phase

Phase 4

Started

2025-11-20

Last updated

2025-11-21

Condition(s) studied

HELICOBACTER PYLORI INFECTIONS

Investigational drug(s) / intervention(s)

Tegoprazan 50 mg →Amoxicillin 1 g TID →Amoxicillin 1.5 g BID →

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

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

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

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: \- 1.Adults aged 18 to 70 years. 2.Confirmed Helicobacter pylori infection by ¹³C-urea breath test, stool antigen test, or gastric biopsy. 3.Able to provide written informed consent. 4.Willing and able to comply with all study procedures, including follow-up testing 4-8 weeks after treatment. Exclusion Criteria: * 1.Known allergy or hypersensitivity to tegoprazan, amoxicillin, or any β-lactam antibiotics. 2.Use of antibiotics, proton pump inhibitors (PPIs), bismuth-containing agents, or potassium-competitive acid blockers within 4 weeks before screening. 3.Severe hepatic impairment (ALT or AST \> 3 × upper limit of normal). 4.Severe renal impairment (estimated glomerular filtration rate \< 30 mL/min/1.73 m²). 5.Pregnant or breastfeeding women. 6.History of gastric surgery or conditions that may affect gastrointestinal absorption. 7.Participation in another clinical trial within the past 30 days. 8.Any condition that, in the investigator's judgment, would make the participant unsuitable for the study.

Primary outcome measure(s)

H. pylori Eradication Rate — 4 to 8 weeks after completion of therapy
Eradication of Helicobacter pylori infection confirmed by a negative ¹³C-urea breath test performed 4 to 8 weeks after the end of the 14-day treatment regimen.

Trial sites (1)

Facility	City	Region	Status
Hangzhou First People's Hospital	Hangzhou	Zhejiang

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07242443 on ClinicalTrials.gov ↗ ← All trials in China