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Tegoprazan-Amoxicillin Dual Therapy vs. Bismuth Quadruple Therapy for H. Pylori Infection (TATH-1)

NCT05647278 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 370

Last updated 2026-01-16

No results posted yet for this study

Summary

Standard eradication therapies using proton pump inhibitors (PPIs) require double doses to achieve sufficient acid suppression, yet failure rates remain high due to antibiotic resistance. Tegoprazan, a P-CAB agent, inhibits gastric acid more effectively than PPIs. This study hypothesizes that Tegoprazan-based dual therapy can achieve superior or non-inferior eradication rates compared to standard quadruple therapy. The study evaluates the antibacterial effect of Tegoprazan combined with high-dose Amoxicillin in H. pylori-infected patients.

Conditions

  • Helicobacter Pylori Infection

Interventions

DRUG

Tegoprazan 50 mg, tablets, orally, qd

Tegoprazan 50 mg, tablets, orally, qd given in combination with amoxicillin 1000mg capsules, orally, tid for up to 2 weeks.

DRUG

Esomeprazole 20mg BID

esomeprazole 20 mg, tablets, orally, bid given in combination with amoxicillin 1000mg，clarithromycin 500mg bid，colloidal bismuth pectin 200mg bid for up to 2 weeks. OR esomeprazole 20 mg, tablets, orally, bis in die given in combination with amoxicillin 750mg capsules, orally, quarter die for up to 2 weeks.

DRUG

Tegoprazan 50 mg, tablets, orally, bid

Tegoprazan 50 mg, tablets, orally, bid given in combination with amoxicillin 1000mg capsules, orally, tid for up to 2 weeks.

DRUG

amoxicillin +clarithromycin+colloidal bismuth pectin BID

amoxicillin 1000mg，clarithromycin 500mg bid，colloidal bismuth pectin 200mg bid for up to 2 weeks

DRUG

amoxicillin 1000mg tid

amoxicillin 1000mg tid

Sponsors & Collaborators

  • Zhang Xiaofeng,MD

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-01
Primary Completion
2025-09-30
Completion
2025-10-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05647278 on ClinicalTrials.gov