drugset / Trial / NCT06523764
Efficacy and Safety of Tegoprazan and Minocycline Dual Therapy for Helicobacter Pylori Initial Treatment
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study was to evaluate the efficacy and safety of tegoprazan and minocycline dual therapy for Helicobacter pylori initial treatment. It is hypothesized that tegoprazan and minocycline dual therapy is non-inferior to bismuth-containing quadruple therapy.Patients diagnosed with H. pylori infection will be randomly divided into one of the above treatments. At week 6 follow-up visits, a urea breath test#rapid urease test or helicobacter pylori stool antigen test will be performed to confirm eradication.
Timeline
- Start
- 2024-11-11
- Primary completion
- 2025-08-01
- Completion
- 2025-10-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Amoxicillin | Other / unclassified | 1000 mg | Oral |
| Comparator | Bismuth Potassium Citrate | Unknown | 240 mg | Oral |
| Comparator | Clarithromycin | Small molecule | 500 mg | Oral |
| Comparator | Esomeprazole | Small molecule | 40 mg | Oral |
| Subject | Minocycline | Small molecule | 100 mg | Oral |
| Subject | Tegoprazan | Other / unclassified | 50 mg | Oral |