A Phase 2/3 interventional study of Tegoprazan and Amoxicillin in Helicobacter Pylori Infection, sponsored by First People's Hospital of Hangzhou. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-11-21.
Sponsored by First People's Hospital of Hangzhou · Phase 2/3, Interventional, and Treatment
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.
This investigator-initiated, randomized, open-label, parallel-group study is designed to compare two potassium-competitive acid blocker (P-CAB)-based dual therapies for the eradication of Helicobacter pylori (H. pylori) infection. The study evaluates a 14-day regimen of tegoprazan 50 mg twice daily combined with amoxicillin 1 g three times daily versus a 14-day regimen of vonoprazan 20 mg twice daily combined with amoxicillin 1 g three times daily.
H. pylori infection is a major cause of chronic gastritis, peptic ulcer disease, and gastric cancer. Rising antimicrobial resistance and variable acid suppression with conventional proton pump inhibitors (PPIs) have highlighted the need for alternative treatment strategies. P-CABs, including tegoprazan and vonoprazan, provide rapid, potent, and sustained acid suppression and may enhance the efficacy of high-dose amoxicillin dual therapy. Despite their increasing clinical use, head-to-head comparative evidence between different P-CAB-based dual therapies is limited.
The primary objective of this study is to determine whether the tegoprazan-based dual regimen is non-inferior to the vonoprazan-based dual regimen in terms of H. pylori eradication rate, assessed by a \^13C-urea breath test performed 4 to 8 weeks after treatment completion. Secondary assessments include treatment-emergent adverse events, serious adverse events, gastrointestinal symptom changes, and medication adherence.
Eligible participants are adults with confirmed H. pylori infection who have not received recent eradication therapy or antibiotics with anti-H. pylori activity. The study drugs have established safety profiles and are administered orally. Participants will be randomized in a 1:1 ratio and followed until completion of eradication testing and safety assessments. Data will be analyzed using both intention-to-treat and per-protocol populations.
This study is conducted at Hangzhou First People's Hospital and is intended to provide direct comparative data to guide the selection of P-CAB-based dual therapy regimens in clinical practice.
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.
Participants in this arm will receive tegoprazan 50 mg taken orally twice daily and amoxicillin 1 g taken orally three times daily for 14 consecutive days. All medications are administered with water after meals. Participants will be followed for assessment of H. pylori eradication 4 to 8 weeks after completing treatment.
Drug: Tegoprazan · Drug: Amoxicillin
Participants in this arm will receive vonoprazan 20 mg taken orally twice daily and amoxicillin 1 g taken orally three times daily for 14 consecutive days. All medications are administered with water after meals. Participants will be followed for assessment of H. pylori eradication 4 to 8 weeks after completing treatment.
Drug: Amoxicillin · Drug: Vonoprazan
Tegoprazan 50 mg orally twice daily for 14 days.
Amoxicillin 1 g orally three times daily for 14 days.
Vonoprazan 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.
Time frame: 4 to 8 weeks after completion of the 14-day treatment regimen
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.
Time frame: From first dose to 2 weeks after completion of treatment (approximately 4 weeks total)
Incidence of Serious Adverse Events (SAEs)
Number and proportion of participants experiencing at least one serious adverse event, as defined by international regulatory criteria.
Time frame: From first dose to end of study follow-up (up to 10 weeks)
Rate of Treatment Discontinuation Due to Adverse Events
Proportion of participants who permanently discontinue the study medication because of adverse events.
Time frame: During the 14-day treatment period
Change in Gastrointestinal Symptom Scores
Change from baseline in gastrointestinal symptom scores (e.g., nausea, bloating, abdominal pain), measured using a standardized symptom questionnaire.
Time frame: Baseline to end of 14-day treatment
Medication Adherence Rate
Percentage of prescribed doses taken by participants, assessed using pill counts and/or patient diaries.
Time frame: During the 14-day treatment period
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.
Time frame: At the time of primary eradication assessment (4 to 8 weeks after completion of the 14-day treatment regimen)
Plan to share: No — Individual participant data (IPD) will not be shared. This study is a single-center, investigator-initiated clinical trial, and there is no plan to make de-identified IPD available to external researchers. Summary results will be published in peer-reviewed journals.
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First People's Hospital of Hangzhou