drugset / Trial / NCT07122024
Efficacy and Safety of Keverprazan-amoxicillin Dual Therapy for Helicobacter Pylori First-line Treatment
RandomizedParallel-groupOpen-labelTreatment
Summary
This is an open-label, randomized controlled study. The study plans to enroll 414 subjects with Helicobacter pylori infection, who will be randomly assigned to the experimental group (Keverprazan dual therapy for 10 days or Keverprazan dual therapy for 14 days) or the control group (Rabeprazole quadruple therapy for 14 days) at a ratio of 1:1:1.
Timeline
- Start
- 2024-02-19
- Primary completion
- 2025-08-31
- Completion
- 2025-12-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Clarithromycin | Small molecule | 500 mg | — |
| Comparator | Colloidal pectin bismuth | Unknown | 200 mg | — |
| Subject | Keverprazan | Unknown | 20 mg | — |
| Comparator | Rabeprazole | Small molecule | 10 mg | — |
| Background | Amoxicillin | Other / unclassified | 1 g | — |