Actively Recruiting
Head-to-head Study of Tegoprazan 50 mg BID Plus Amoxicillin 1 g TID vs. Vonoprazan 20 mg BID Plus Amoxicillin 1 g TID for H. Pylori Eradication
Led by First People's Hospital of Hangzhou · Updated on 2025-11-21
240
Participants Needed
1
Research Sites
49 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a randomized, open-label, parallel-group clinical trial designed to compare two 14-day dual therapies for the eradication of Helicobacter pylori (H. pylori) infection. Participants will be randomly assigned to receive 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 purpose of this study is to evaluate whether the tegoprazan-based regimen is non-inferior to the vonoprazan-based regimen in terms of H. pylori eradication rates. Eradication will be assessed 4 to 8 weeks after completing therapy using a \^13C-urea breath test. Secondary objectives include assessing treatment-related adverse events, tolerability, and medication adherence. This study involves adult participants with confirmed H. pylori infection. All study medications are orally administered, and both regimens use drugs with well-established safety profiles. The study is investigator-initiated and conducted at Hangzhou First People's Hospital.
CONDITIONS
Official Title
Head-to-head Study of Tegoprazan 50 mg BID Plus Amoxicillin 1 g TID vs. Vonoprazan 20 mg BID Plus Amoxicillin 1 g TID for H. Pylori Eradication
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 70 years
- Confirmed Helicobacter pylori infection by at least one positive test (13C-urea breath test, rapid urease test, histology, or stool antigen test)
- Able and willing to provide written informed consent
- Able to comply with study procedures and visits
- For females of childbearing potential, agreement to use effective contraception during the study period
You will not qualify if you...
- Previous Helicobacter pylori eradication therapy within the past 12 months
- Use of antibiotics, bismuth compounds, or other anti-H. pylori medications within 4 weeks before baseline testing
- Use of proton pump inhibitors, P-CABs, or H2-receptor antagonists within 2 weeks before baseline testing
- Known allergy or intolerance to tegoprazan, vonoprazan, amoxicillin, or any beta-lactam antibiotic
- Severe liver impairment (e.g., Child-Pugh C) or severe kidney impairment (e.g., eGFR < 30 mL/min/1.73 m²)
- History of gastric surgery except minor endoscopic procedures that don't affect stomach anatomy
- Active gastrointestinal bleeding or suspected stomach cancer
- Pregnant or breastfeeding women
- Participation in another interventional trial within the past 30 days
- Any medical or psychiatric condition that could interfere with study participation or pose unacceptable risk
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hangzhou First People's Hospital, Department of Gastroenterology (Helicobacter pylori Standardized Diagnosis and Treatment Clinic, National Demonstration Center)
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
H
Hongzhang Shen, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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