drugset / Trial / NCT02175901
Amoxicillin/Metronidazole Based Quadruple Therapy for Helicobacter Pylori Eradication
RandomizedParallel-groupOpen-labelTreatment
Summary
No trial has examined the the efficacy of amoxicillin and metronidazole based quadruple therapy for Helicobacter pylori treatment. The study aims to compare the effectiveness and safety of 14-day amoxicillin-/metronidazole-based quadruple regiment and classical quadruple regiment for Helicobacter pylori eradication.
Timeline
- Start
- 2014-07
- Primary completion
- 2015-01
- Completion
- 2015-01
Publications
- Background Malfertheiner P, Megraud F, O'Morain CA, Atherton J, Axon AT, Bazzoli F, Gensini GF, Gisbert JP, Graham DY, Rokkas T, El-Omar EM, Kuipers EJ; European Helicobacter Study Group. Management of Helicobacter pylori infection--the Maastricht IV/ Florence Consensus Report. Gut. 2012 May;61(5):646-64. doi: 10.1136/gutjnl-2012-302084.
- Background Sun Q, Liang X, Zheng Q, Liu W, Xiao S, Gu W, Lu H. High efficacy of 14-day triple therapy-based, bismuth-containing quadruple therapy for initial Helicobacter pylori eradication. Helicobacter. 2010 Jun;15(3):233-8. doi: 10.1111/j.1523-5378.2010.00758.x.
- Background Lu H, Zhang W, Graham DY. Bismuth-containing quadruple therapy for Helicobacter pylori: lessons from China. Eur J Gastroenterol Hepatol. 2013 Oct;25(10):1134-40. doi: 10.1097/MEG.0b013e3283633b57.
- Zhang W, Chen Q, Liang X, Liu W, Xiao S, Graham DY, Lu H. Bismuth, lansoprazole, amoxicillin and metronidazole or clarithromycin as first-line Helicobacter pylori therapy. Gut. 2015 Nov;64(11):1715-20. doi: 10.1136/gutjnl-2015-309900. Epub 2015 Sep 2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Clarithromycin | Small molecule | 500 mg | — |
| Subject | Metronidazole | Small molecule | 400 mg | — |
| Background | Amoxicillin | Other / unclassified | 1000 mg | — |
| Background | Bismuth Potassium Citrate | Unknown | 220 mg | — |
| Background | Lansoprazole | Other / unclassified | 30 mg | — |