RecruitingPhase 2Phase 3NCT07242456

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

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

Sponsor

First People's Hospital of Hangzhou

Enrollment

240 participants

Start Date

Feb 17, 2025

Study Type

INTERVENTIONAL

Conditions

Helicobacter Pylori Infection

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria1

\. 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 Criteria3

\. 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).
\. Active gastrointestinal bleeding or suspected gastric malignancy. 8. Pregnant or breastfeeding women. 9. Participation in another interventional clinical trial within the past 30 days.
\. Any medical or psychiatric condition that, in the investigator's judgment, could interfere with study participation or pose unacceptable risk.

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Interventions

DRUGTegoprazan

Tegoprazan 50 mg orally twice daily for 14 days.

DRUGAmoxicillin

Amoxicillin 1 g orally three times daily for 14 days.

DRUGVonoprazan

Vonoprazan 20 mg orally twice daily for 14 days.

Locations(1)

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

Hangzhou, Zhejiang, China

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NCT07242456