Tegoprazan Plus Amoxicillin BID vs TID Regimens for H. Pylori Eradication（Frequency Adjusted Same-dose Therapy for H. Pylori）
NCT ID: NCT07242443
Last Updated: 2025-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
240 participants
INTERVENTIONAL
2025-11-20
2026-12-31
Brief Summary
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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.
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Detailed Description
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Tegoprazan is a potassium-competitive acid blocker (P-CAB) that provides rapid, potent, and sustained gastric acid inhibition, which may enhance the effectiveness of amoxicillin-based dual therapy. Amoxicillin resistance remains low in many regions, and its efficacy is closely related to maintaining intragastric pH levels that support bacterial replication.
The standard tegoprazan dual therapy uses amoxicillin 1 gram three times daily (TID). However, TID dosing may affect patient adherence, which can influence eradication outcomes. This study explores an alternative regimen: amoxicillin 1.5 grams twice daily (BID). The two regimens deliver the same total daily dose of 3 grams of amoxicillin, but the BID schedule may improve convenience and medication compliance while maintaining appropriate pharmacodynamic exposure.
This randomized, controlled clinical trial is designed to compare the eradication efficacy, safety, and tolerability of these two dosing strategies in adults with confirmed H. pylori infection. By evaluating whether a simplified BID regimen can achieve non-inferior or superior eradication rates compared with the standard TID regimen, the study aims to provide evidence that may support more convenient dual therapy options for H. pylori management.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Tegoprazan 50 mg BID + Amoxicillin 1 g TID
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.
Tegoprazan 50 mg
Tegoprazan 50 mg administered orally twice daily (BID) for 14 days.
Amoxicillin 1 g TID
Amoxicillin 1 gram administered orally three times daily (TID) for 14 days.
Tegoprazan 50 mg BID + Amoxicillin 1.5 g BID
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.
Tegoprazan 50 mg
Tegoprazan 50 mg administered orally twice daily (BID) for 14 days.
Amoxicillin 1.5 g BID
Amoxicillin 1.5 grams administered orally twice daily (BID) for 14 days.
Interventions
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Tegoprazan 50 mg
Tegoprazan 50 mg administered orally twice daily (BID) for 14 days.
Amoxicillin 1 g TID
Amoxicillin 1 gram administered orally three times daily (TID) for 14 days.
Amoxicillin 1.5 g BID
Amoxicillin 1.5 grams administered orally twice daily (BID) for 14 days.
Eligibility Criteria
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Inclusion Criteria
3.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.
Exclusion Criteria
2.Use of antibiotics, proton pump inhibitors (PPIs), bismuth-containing agents, or potassium-competitive acid blockers within 4 weeks before screening.
3.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).
5.Pregnant or breastfeeding women. 6.History of gastric surgery or conditions that may affect gastrointestinal absorption.
7.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.
18 Years
75 Years
ALL
No
Sponsors
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First People's Hospital of Hangzhou
OTHER
Responsible Party
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Locations
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Hangzhou First People's Hospital
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BCF-LX-XH-20221014-26
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
HP-TGZ-AMO-3g-FrequencyStudy
Identifier Type: -
Identifier Source: org_study_id
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