drugset / Trial / NCT04359966
Prospective Randomised Trial of First and Second Line Treatments of RCT of First and Second Line H Pylori Treatments in Slovenia
RandomizedParallel-groupOpen-labelTreatment
Summary
Study is prospective randomised multicentric. The primary objective of the study is to compare the efficacy of two first-line therapy regimens and two second-line therapy regimens (ie, after failure of first-line treatment) in patients with H. pylori infection. The secondary objective of the study is to determine the primary resistance of H. pylori to antibiotics in Slovenia.
Timeline
- Start
- 2020-05-10
- Primary completion
- 2023-05-31
- Completion
- 2023-09-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Amoxicillin | Other / unclassified | 500 mg | — |
| Comparator | Amoxicillin | Other / unclassified | 1000 mg | — |
| Comparator | Clarithromycin | Small molecule | 500 mg | — |
| Comparator | Esomeprazole | Small molecule | 40 mg | — |
| Subject | Levofloxacin | Small molecule | 500 mg | — |
| Comparator | Metronidazole | Small molecule | 400 mg | — |
| Comparator | bismuth subcitrate | Unknown | 120 mg | — |