Tegoprazan 50 mg twice daily plus amoxicillin versus vonoprazan 20 mg twice daily plus amoxicillin for H. pylori eradication
Head-to-head Comparison of Tegoprazan 50 mg BID Plus Amoxicillin 1 g TID Versus Vonoprazan 20 mg BID Plus Amoxicillin 1 g TID for Helicobacter Pylori Eradication: A Randomized, Open-label, Parallel-group Study
This trial tests whether a 14-day tegoprazan plus amoxicillin regimen works as well as a vonoprazan plus amoxicillin regimen to cure Helicobacter pylori infection in adults.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | First People's Hospital of Hangzhou Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT07242456 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18 to 70 with confirmed H. pylori infection who can provide informed consent and attend study visits are the intended participants.
Not a fit: People who recently had H. pylori eradication therapy, recently used antibiotics or acid-suppressing drugs, are allergic to amoxicillin or P-CABs, are pregnant, or have severe liver or kidney impairment are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, the tegoprazan-based regimen could provide an effective, well-tolerated 14-day dual therapy option for adults with H. pylori infection.
How similar studies have performed: Vonoprazan-plus-amoxicillin dual therapy has shown high eradication rates in previous studies, while head-to-head comparisons between different P-CABs like tegoprazan and vonoprazan remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Hangzhou, Zhejiang
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.