Tegoprazan 50 mg twice daily plus amoxicillin versus vonoprazan 20 mg twice daily plus amoxicillin for H. pylori eradication

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, open-label, parallel-group trial enrolls adults with confirmed H. pylori infection and assigns them to 14 days of either tegoprazan 50 mg twice daily plus amoxicillin 1 g three times daily or vonoprazan 20 mg twice daily plus amoxicillin 1 g three times daily. The primary endpoint is H. pylori eradication measured by a 13C-urea breath test 4 to 8 weeks after completing therapy. Secondary outcomes include treatment-emergent adverse events, tolerability, gastrointestinal symptom changes, and medication adherence. The trial is investigator-initiated and conducted at Hangzhou First People's Hospital with routine safety monitoring.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 1\. Adults aged 18 to 70 years. 2. Confirmed Helicobacter pylori infection based on at least one positive test (13C-urea breath test, rapid urease test, histology, or stool antigen test). 3. Able and willing to provide written informed consent. 4. Able to comply with study procedures and visits. 5. For females of childbearing potential: agreement to use effective contraception during the study period.

Exclusion Criteria:

* 1\. Previous Helicobacter pylori eradication therapy within the past 12 months. 2. Use of antibiotics, bismuth compounds, or other medications with anti-H. pylori activity within 4 weeks before baseline testing. 3. Use of proton pump inhibitors, P-CABs, or H2-receptor antagonists within 2 weeks before baseline testing. 4. Known allergy or intolerance to tegoprazan, vonoprazan, amoxicillin, or any beta-lactam antibiotic. 5. Known severe hepatic impairment (e.g., Child-Pugh C) or severe renal impairment (e.g., eGFR \< 30 mL/min/1.73 m²). 6. History of gastric surgery (except minor endoscopic procedures that do not affect gastric anatomy).

  7\. Active gastrointestinal bleeding or suspected gastric malignancy. 8. Pregnant or breastfeeding women. 9. Participation in another interventional clinical trial within the past 30 days.

  10\. Any medical or psychiatric condition that, in the investigator's judgment, could interfere with study participation or pose unacceptable risk.

Where it's running

• Hangzhou First People's Hospital, Department of Gastroenterology (Helicobacter pylori Standardized Diagnosis and Treatment Clinic, National Demonstration Center)
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Hongzhang Shen, PhD
• Email: shz@zcmu.edu.cn
• Phone: 0086-15067174028

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Potassium-competitive acid blocker versus proton pump inhibitor with bismuth quadruple therapy for H. pylori infection

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.