Standard eradication therapies using proton pump inhibitors (PPIs) require double doses to achieve sufficient acid suppression, yet failure rates remain high due to antibiotic resistance. Tegoprazan, a P-CAB agent, inhibits gastric acid more effectively than PPIs. This study hypothesizes that Tegoprazan-based dual therapy can achieve superior or non-inferior eradication rates compared to standard quadruple therapy. The study evaluates the antibacterial effect of Tegoprazan combined with high-dose Amoxicillin in H. pylori-infected patients.
Note on Protocol Amendment and Registration Update: The study protocol was amended in November 2023 to include a randomized comparison of Tegoprazan 50 mg QD versus BID (within the TAT arm) and to adjust the Amoxicillin dosage to 1000 mg TID. Important Explanation: Although this amendment was approved by the Ethics Committee and implemented immediately, the update to the ClinicalTrials.gov registry was delayed due to an administrative oversight by the research team. The inclusion of the BID arm and the secondary randomization were pre-planned and executed strictly according to the protocol, not as a post-hoc analysis. Study Description: Helicobacter pylori infection is a major cause of gastric diseases. Currently, Bismuth Quadruple Therapy (BQT) is the recommended first-line treatment in China. However, the efficacy of BQT is increasingly challenged by antibiotic resistance (especially to clarithromycin) and complex dosing regimens, which can reduce patient compliance. Tegoprazan is a novel potassium-competitive acid blocker (P-CAB) that provides rapid, potent, and durable acid suppression, theoretically creating an ideal environment for amoxicillin to eradicate H. pylori. Unlike proton pump inhibitors (PPIs), Tegoprazan does not require activation by acid and is less influenced by CYP2C19 genetic polymorphisms. This prospective, randomized, multicenter study aims to compare the efficacy, safety, and compliance of 14-day Tegoprazan-Amoxicillin Dual Therapy (TAT) versus Esomeprazole-based Bismuth Quadruple Therapy (BQT) in treatment-naïve patients. The study hypothesizes that the TAT regimen is superior or non-inferior to the standard BQT regimen in eradicating H. pylori infection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Tegoprazan 50 mg, tablets, orally, qd given in combination with amoxicillin 1000mg capsules, orally, tid for up to 2 weeks.
esomeprazole 20 mg, tablets, orally, bid given in combination with amoxicillin 1000mg，clarithromycin 500mg bid，colloidal bismuth pectin 200mg bid for up to 2 weeks. OR esomeprazole 20 mg, tablets, orally, bis in die given in combination with amoxicillin 750mg capsules, orally, quarter die for up to 2 weeks.
Tegoprazan 50 mg, tablets, orally, bid given in combination with amoxicillin 1000mg capsules, orally, tid for up to 2 weeks.
Hangzhou first people's Hospital
Hangzhou, Zhejiang, China
Percentage of Helicobacter Pylori Positive (HP+) Participants With Successful HP Eradication at Week 4 Post- Treatment
HP infection status will be determined by \^13C Urea Breath Test (\^13C-UBT). The urea breath test is used to detect infection with HP, a bacteria associated with stomach ulcers, by testing individual breath samples in a central laboratory.
Time frame: Week 4-8 post-treatment
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Masking
NONE
Enrollment
370
amoxicillin 1000mg，clarithromycin 500mg bid，colloidal bismuth pectin 200mg bid for up to 2 weeks
amoxicillin 1000mg tid