drugset / Trial / NCT05189444
The Evaluation of Triple Therapy With Vonoprazan, Amoxicillin and Bismuth for Eradication of Helicobacter Pylori
RandomizedParallel-groupOpen-labelTreatment
Summary
The eradication rate of standard quadruple therapy has become less successful due to low compliance and high resistance to antibiotics. Therefore, it is necessary to develop new treatment strategies that increase the eradication rate and reduce adverse effects. The aim of this prospective study is to investigate the efficacy of Triple Therapy with Vonoprazan, Amoxicillin, and Bismuth for eradication of Hp, compared with standard quadruple therapy.
Timeline
- Start
- 2022-03-25
- Primary completion
- 2022-12-31
- Completion
- 2022-12-31
Publications
- Results Gunaratne AW, Hamblin H, Clancy A, Magat AJMC, Dawson MVM, Tu J, Borody TJ. Combinations of antibiotics and vonoprazan for the treatment of Helicobacter pylori infections-Exploratory study. Helicobacter. 2021 Oct;26(5):e12830. doi: 10.1111/hel.12830. Epub 2021 Jul 10.
- Results Rokkas T, Gisbert JP, Malfertheiner P, Niv Y, Gasbarrini A, Leja M, Megraud F, O'Morain C, Graham DY. Comparative Effectiveness of Multiple Different First-Line Treatment Regimens for Helicobacter pylori Infection: A Network Meta-analysis. Gastroenterology. 2021 Aug;161(2):495-507.e4. doi: 10.1053/j.gastro.2021.04.012. Epub 2021 Apr 8.
- Results Kiyotoki S, Nishikawa J, Sakaida I. Efficacy of Vonoprazan for Helicobacter pylori Eradication. Intern Med. 2020 Jan 15;59(2):153-161. doi: 10.2169/internalmedicine.2521-18. Epub 2019 Jun 27.
- Results Ang TL, Ang D. Helicobacter pylori Treatment Strategies in Singapore. Gut Liver. 2021 Jan 15;15(1):13-18. doi: 10.5009/gnl19308.
- Results Kao CY, Sheu BS, Wu JJ. Helicobacter pylori infection: An overview of bacterial virulence factors and pathogenesis. Biomed J. 2016 Feb;39(1):14-23. doi: 10.1016/j.bj.2015.06.002. Epub 2016 Apr 1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Amoxicillin | Other / unclassified | 0.75 g | — |
| Comparator | Amoxicillin | Other / unclassified | 1 g | — |
| Comparator | Clarithromycin | Small molecule | 0.5 g | — |
| Comparator | Esomeprazole | Small molecule | 20 mg | — |
| Subject | Vonoprazan | Other / unclassified | 20 mg | — |
| Background | Bismuth Potassium Citrate | Unknown | 0.22 g | — |