drugset / Trial / NCT04678492
Helicobacter Rescue Therapy With High-dose Esomeprazole and Amoxicillin Dual Therapy Versus Bismuth-containing Quadruple Therapy
RandomizedParallel-groupOpen-labelTreatment
Summary
This study aims at evaluating efficacy and safety of high-dose esomeprazole and amoxicillin dual therapy(esomeprazole and amoxicillin) versus bismuth-containing quadruple Therapy(bismuth,esomeprazole,tetracycline and furazolidone) in H. pylori rescue therapy. It is hypothesized that high-dose esomeprazole and amoxicillin dual therapy is non-inferior to bismuth-containing quadruple Therapy. Patients with confirmed failure of H. pylori eradication will be randomized to one of the treatments described above. 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
- 2020-12-20
- Primary completion
- 2021-12-20
- Completion
- 2021-12-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amoxicillin | Other / unclassified | 1000 mg | Oral |
| Comparator | Bismuth Potassium Citrate | Unknown | 220 mg | Oral |
| Comparator | Esomeprazole | Small molecule | 40 mg | Oral |
| Comparator | Furazolidone | Small molecule | 100 mg | Oral |
| Comparator | Tetracycline | Unknown | 500 mg | Oral |