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

NCT07242456 | Recruiting Phase 2

• 2 other identifiers: TV-HP-2024-01BCF-LX-XH-20221014-26
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Helicobacter Pylori Infection

Outcome Measures

Primary Outcomes (1)

• 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.

  4 to 8 weeks after completion of the 14-day treatment regimen

Secondary Outcomes (5)

• Incidence of Treatment-Emergent Adverse Events (TEAEs)

  From first dose to 2 weeks after completion of treatment (approximately 4 weeks total)

• Incidence of Serious Adverse Events (SAEs)

  From first dose to end of study follow-up (up to 10 weeks)

• Rate of Treatment Discontinuation Due to Adverse Events

  During the 14-day treatment period

• Change in Gastrointestinal Symptom Scores

  Baseline to end of 14-day treatment

• Medication Adherence Rate

  During the 14-day treatment period

Other Outcomes (1)

• Subgroup Analysis by CYP2C19 Metabolizer Status

  At the time of primary eradication assessment (4 to 8 weeks after completion of the 14-day treatment regimen)

Study Arms (2)

Tegoprazan + Amoxicillin (14-day dual therapy)

EXPERIMENTAL

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

Vonoprazan + Amoxicillin (14-day dual therapy)

EXPERIMENTAL

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

Interventions

Tegoprazan DRUG

Tegoprazan 50 mg orally twice daily for 14 days.

Tegoprazan + Amoxicillin (14-day dual therapy)

Amoxicillin DRUG

Amoxicillin 1 g orally three times daily for 14 days.

Tegoprazan + Amoxicillin (14-day dual therapy); Vonoprazan + Amoxicillin (14-day dual therapy)

Vonoprazan DRUG

Vonoprazan 20 mg orally twice daily for 14 days.

Vonoprazan + Amoxicillin (14-day dual therapy)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• First People's Hospital of Hangzhou: lead

Study Sites (1)

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

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Interventions

tegoprazan; Amoxicillin; 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Hongzhang Shen, PhD

CONTACT

0086-15067174028; shz@zcmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Not applicable. This is an open-label study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician, Department of Gastroenterology, Hangzhou First People's Hospital

Model Details: Participants will be randomly assigned in a 1:1 ratio to one of two treatment arms and will receive the assigned regimen for 14 days. Both groups will be followed in parallel, with no crossover or sequence changes. Outcomes will be assessed at predefined follow-up visits.

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 21, 2025
• Study Start: February 17, 2025
• Primary Completion: November 15, 2025
• Study Completion: January 31, 2026
• Last Updated: November 21, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)