drugset / Trial / NCT03592069
Concomitant Versus Hybrid Regimen for H. Pylori Eradication
Phase 4
Completed
345 enrolled
Alexandra Hospital, Athens, Greece
Hellenic Society of Gastroenterology · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
10 day concomitant versus 14 day hybrid regimen as first line H. pylori eradication treatment in a high clarithromycin resistance area. A multicenter, randomized, equivalence trial.
Timeline
- Start
- 2018-02-21
- Primary completion
- 2020-10-21
- Completion
- 2021-01-31
Publications
- Background Sugano K, Tack J, Kuipers EJ, Graham DY, El-Omar EM, Miura S, Haruma K, Asaka M, Uemura N, Malfertheiner P; faculty members of Kyoto Global Consensus Conference. Kyoto global consensus report on Helicobacter pylori gastritis. Gut. 2015 Sep;64(9):1353-67. doi: 10.1136/gutjnl-2015-309252. Epub 2015 Jul 17.
- Background Megraud F, Coenen S, Versporten A, Kist M, Lopez-Brea M, Hirschl AM, Andersen LP, Goossens H, Glupczynski Y; Study Group participants. Helicobacter pylori resistance to antibiotics in Europe and its relationship to antibiotic consumption. Gut. 2013 Jan;62(1):34-42. doi: 10.1136/gutjnl-2012-302254. Epub 2012 May 12.
- Background Georgopoulos SD, Xirouchakis E, Martinez-Gonzales B, Zampeli E, Grivas E, Spiliadi C, Sotiropoulou M, Petraki K, Zografos K, Laoudi F, Sgouras D, Mentis A, Kasapidis P, Michopoulos S. Randomized clinical trial comparing ten day concomitant and sequential therapies for Helicobacter pylori eradication in a high clarithromycin resistance area. Eur J Intern Med. 2016 Jul;32:84-90. doi: 10.1016/j.ejim.2016.04.011. Epub 2016 Apr 28.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Amoxicillin | Other / unclassified | 1 g | — |
| Comparator | Clarithromycin | Small molecule | 500 mg | — |
| Comparator | Esomeprazole | Small molecule | 40 mg | — |
| Comparator | Metronidazole | Small molecule | 500 mg | — |