Tegoprazan Plus Amoxicillin BID vs TID Regimens for H. Pylori Eradication（Frequency Adjusted Same-dose Therapy for H. Pylori）

NCT07242443 | Not Yet Recruiting Phase 4

• 2 other identifiers: HP-TGZ-AMO-3g-FrequencyStudyBCF-LX-XH-20221014-26
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to evaluate two different tegoprazan-based dual therapy regimens for the treatment of Helicobacter pylori (H. pylori) infection. All participants will receive tegoprazan 50 mg twice daily for 14 days, combined with one of two amoxicillin dosing schedules that contain the same total daily dose of 3 grams of amoxicillin. One group will receive amoxicillin 1 gram three times daily (TID), which is the standard regimen. The other group will receive amoxicillin 1.5 grams twice daily (BID), an alternative schedule that may improve convenience and treatment adherence while maintaining the same total daily antibiotic amount. A total of 240 adults with confirmed H. pylori infection will be randomly assigned to one of the two treatment groups. The main goal of the study is to compare the H. pylori eradication rates between the two regimens. Eradication will be assessed 4 to 8 weeks after completing therapy using a ¹³C-urea breath test. Safety, tolerability, and medication adherence will also be monitored.

Conditions

HELICOBACTER PYLORI INFECTIONS

Keywords

Helicobacter pylori; H. pylori; Amoxicillin; Tegoprazan; Dual Therapy; BID Dosing; TID Dosing; Fixed-Dose Regimen; P-CAB; Frequency Comparison; Antibiotic Regimen Optimization

Outcome Measures

Primary Outcomes (1)

• H. pylori Eradication Rate

  Eradication of Helicobacter pylori infection confirmed by a negative ¹³C-urea breath test performed 4 to 8 weeks after the end of the 14-day treatment regimen.

  4 to 8 weeks after completion of therapy

Secondary Outcomes (4)

• Incidence of Adverse Events

  From Day 1 to Day 14 (treatment period)

• Incidence of Serious Adverse Events (SAEs)

  From Day 1 to study completion (approximately 8-10 weeks)

• Medication Adherence Rate

  Day 1 to Day 14

• Change in Gastrointestinal Symptom Scores

  Baseline to Day 14

Study Arms (2)

Tegoprazan 50 mg BID + Amoxicillin 1 g TID

ACTIVE COMPARATOR

Participants in this arm will receive tegoprazan 50 mg orally twice daily (BID) in combination with amoxicillin 1 gram orally three times daily (TID) for 14 days. This regimen represents the standard dual therapy dosing schedule for Helicobacter pylori eradication.

Drug: Tegoprazan 50 mg; Drug: Amoxicillin 1 g TID

Tegoprazan 50 mg BID + Amoxicillin 1.5 g BID

EXPERIMENTAL

Participants in this arm will receive tegoprazan 50 mg orally twice daily (BID) in combination with amoxicillin 1.5 grams orally twice daily (BID) for 14 days. This regimen delivers the same total daily dose of amoxicillin (3 grams) as the standard therapy but uses a reduced dosing frequency to evaluate whether a BID schedule can improve convenience, adherence, and eradication outcomes.

Drug: Tegoprazan 50 mg; Drug: Amoxicillin 1.5 g BID

Interventions

Tegoprazan 50 mg DRUG

Tegoprazan 50 mg administered orally twice daily (BID) for 14 days.

Tegoprazan 50 mg BID + Amoxicillin 1 g TID; Tegoprazan 50 mg BID + Amoxicillin 1.5 g BID

Amoxicillin 1 g TID DRUG

Amoxicillin 1 gram administered orally three times daily (TID) for 14 days.

Tegoprazan 50 mg BID + Amoxicillin 1 g TID

Amoxicillin 1.5 g BID DRUG

Amoxicillin 1.5 grams administered orally twice daily (BID) for 14 days.

Tegoprazan 50 mg BID + Amoxicillin 1.5 g BID

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 1.Adults aged 18 to 70 years. 2.Confirmed Helicobacter pylori infection by ¹³C-urea breath test, stool antigen test, or gastric biopsy.
• Able to provide written informed consent. 4.Willing and able to comply with all study procedures, including follow-up testing 4-8 weeks after treatment.

You may not qualify if:

• Known allergy or hypersensitivity to tegoprazan, amoxicillin, or any β-lactam antibiotics.
• Use of antibiotics, proton pump inhibitors (PPIs), bismuth-containing agents, or potassium-competitive acid blockers within 4 weeks before screening.
• Severe hepatic impairment (ALT or AST \> 3 × upper limit of normal). 4.Severe renal impairment (estimated glomerular filtration rate \< 30 mL/min/1.73 m²).
• Pregnant or breastfeeding women. 6.History of gastric surgery or conditions that may affect gastrointestinal absorption.
• Participation in another clinical trial within the past 30 days. 8.Any condition that, in the investigator's judgment, would make the participant unsuitable for the study.

Sponsors & Collaborators

• First People's Hospital of Hangzhou: lead

Study Sites (1)

Hangzhou First People's Hospital

Hangzhou, Zhejiang, 310006, China

Location

MeSH Terms

Interventions

tegoprazan; Amoxicillin; BID protein, human

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/MD

CONTACT

+86-150-6717-4028; shz@zcmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label trial. Masking is not feasible because the two study arms use different dosing frequencies (BID vs TID), which cannot be blinded to participants or study personnel.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized, two-arm, parallel-group study in which participants are allocated in a 1:1 ratio to receive tegoprazan plus amoxicillin 1 g TID or tegoprazan plus amoxicillin 1.5 g BID for 14 days.

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 21, 2025
• Study Start: November 20, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 21, 2025

Record last verified: 2025-11

Locations

CN (1)