Phase 2Completed
Efficacy and Safety Study of Finafloxacin Used in Helicobacter Pylori Infected Patients (FLASH)
An Open-Label, Randomized, Multicenter, Two-Arms Efficacy and Safety Study of 14 Days Treatment With Finafloxacin 400 mg b.i.d. Plus Amoxicillin 1000 mg b.i.d.Versus Finafloxacin 400 mg b.i.d. Plus Esomeprazole 40 mg b.i.d. in Patients With Helicobacter Pylori Infection
- Sponsor
- MerLion Pharmaceuticals GmbH (Industry)
- Enrollment
- 30 planned
- Conditions
- Gram-Negative Bacterial Infections; Helicobacter Infections; Dyspepsia
- Interventions
- Finafloxacin + Amoxicillin; Finafloxacin + Esomeprazole
- Ages
- adults, older adults
- Registry
- NCT00723502
Full record on ClinicalTrials.gov
From the registry
The primary objective of this study is to compare the H. pylori eradication rates with Finafloxacin in combination with Amoxicillin or Esomeprazole. The secondary objective is to evaluate and compare the safety and tolerability of multiple oral doses of Finafloxacin plus Amoxicillin versus Finafloxacin plus Esomeprazole.
Primary outcomes
- Eradication of Helicobacter pylori
History
Last registry update
Primary completion
Started
Registered