drugset / Trial / NCT02422706

Study of Nitazoxanide (NTZ) Based New Therapeutic Regimens for Helicobacter Pylori

NCT02422706

Phase 3 Unknown 120 enrolled Tanta University Tanta University · collab
RandomizedParallel-groupDouble-blindTreatment

Summary

Current Helicobacter Pylori infection preferred treatment involves; proton pump inhibitor (PPI)-based triple or qudrable regimens. Omeprazole, Amoxicillin, and Clarithromycin is one of a global standard care for confirmed H.pylori infection . Metronidazole (MTZ) is used instead of Amoxicillin or Clarithromycin in cases of allergy or resistance . However, a recent study based on the Maastricht III guidelines, indicated that treatment with a PPI-based triple regimen as first-line therapy will fail in \~30% of patients on an intention-to-treat (ITT) basis, and will fail in \~ 50 % of patients who treated with PPI-based triple regimen with Metronidazole. This treatment resistance is also an issue warranting the investigation of other agents. Helicobacter pylori infection has become increasingly resistant to traditional first-line treatment regimens because of emerging antibiotic resistance coupled with poor patient compliance with completing the treatment course that decrease H. pylori eradication rates. So there is a considerable interest in evaluating new antibiotic combinations and regimens .

Timeline

Start
2015-01
Primary completion
2018-12
Completion
2018-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Clarithromycin Small molecule 500 mg
Subject Doxicycline Unknown 100 mg
Subject Levofloxacin Small molecule 250 mg
Comparator Metronidazole Small molecule 500 mg
Subject Nitazoxanide Other / unclassified 500 mg
Subject Omeprazole Other / unclassified 20 mg
Subject Omeprazole Other / unclassified 40 mg

Indications