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.
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.
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).
Parallel
Tegoprazan
DrugTegoprazan 50 mg orally twice daily for 14 days.
Amoxicillin
DrugAmoxicillin 1 g orally three times daily for 14 days.
Vonoprazan
DrugVonoprazan 20 mg orally twice daily for 14 days.
Helicobacter pylori Eradication Rate (ITT and PP)
H. pylori eradication will be defined as a negative \^13C-urea breath test performed at the follow-up visit. Eradication rates will be assessed in both the intention-to-treat (ITT) and per-protocol (PP) populations. A participant will be considered eradicated only if the test result is negative without the use of prohibited medications.
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Number and proportion of participants experiencing at least one treatment-emergent adverse event, classified by severity and relationship to study medication.
Incidence of Serious Adverse Events (SAEs)
Number and proportion of participants experiencing at least one serious adverse event, as defined by international regulatory criteria.
Rate of Treatment Discontinuation Due to Adverse Events
Proportion of participants who permanently discontinue the study medication because of adverse events.
Change in Gastrointestinal Symptom Scores
Change from baseline in gastrointestinal symptom scores (e.g., nausea, bloating, abdominal pain), measured using a standardized symptom questionnaire.
Subgroup Analysis by CYP2C19 Metabolizer Status
If genotyping is performed, participants will be categorized into metabolizer groups (e.g., poor, intermediate, extensive, rapid metabolizers). H. pylori eradication rates will be compared across CYP2C19 phenotypes to explore potential differences in treatment response to P-CAB-based dual therapy.
Click on the lead sponsor to view all of their trials.
