drugset / Trial / NCT05647278
Tegoprazan-Amoxicillin Dual Therapy vs. Bismuth Quadruple Therapy for H. Pylori Infection (TATH-1)
RandomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2023-11-01
- Primary completion
- 2025-09-30
- Completion
- 2025-10-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amoxicillin | Other / unclassified | 750 mg | Oral |
| Subject | Amoxicillin | Other / unclassified | 1000 mg | Oral |
| Comparator | Clarithromycin | Small molecule | 500 mg | Oral |
| Comparator | Esomeprazole | Small molecule | 20 mg | Oral |
| Subject | Tegoprazan | Other / unclassified | 50 mg | Oral |
| Comparator | colloidal bismuth pectin | Unknown | 200 mg | Oral |