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.
None
1.Known allergy or hypersensitivity to tegoprazan, amoxicillin, or any β-lactam antibiotics.
Parallel
Tegoprazan 50 mg
DrugTegoprazan 50 mg administered orally twice daily (BID) for 14 days.
Amoxicillin 1 g TID
DrugAmoxicillin 1 gram administered orally three times daily (TID) for 14 days.
Amoxicillin 1.5 g BID
DrugAmoxicillin 1.5 grams administered orally twice daily (BID) for 14 days.
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.
Incidence of Adverse Events
The number and proportion of participants reporting any adverse events during the 14-day treatment period, assessed by patient report, clinical evaluation, and laboratory findings.
Incidence of Serious Adverse Events (SAEs)
Serious adverse events, defined according to standard regulatory criteria (life-threatening events, hospitalization, significant disability, or other medically significant events).
Medication Adherence Rate
Adherence assessed by pill count and participant self-report. Adherence will be expressed as the percentage of prescribed doses actually taken during the 14-day treatment period.
Change in Gastrointestinal Symptom Scores
Improvement in gastrointestinal symptoms (such as epigastric discomfort, bloating, nausea), assessed using a standardized symptom questionnaire. Higher scores indicate more severe symptoms.
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