NCT00723502

Efficacy and Safety Study of Finafloxacin Used in Helicobacter Pylori Infected Patients

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: MerLion Pharmaceuticals GmbH · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Gram-Negative Bacterial Infections
• Helicobacter Infections
• Dyspepsia

Interventions

Type	Name	Description
DRUG	Finafloxacin + Amoxicillin	Finafloxacin, tablets, 400 mg b.i.d. (8 X 50 mg tablets), oral administration; Amoxicillin, tablet 1000 mg b.i.d. (1 X 1000 mg tablet), oral administration
DRUG	Finafloxacin + Esomeprazole	Finafloxacin, tablets, 400 mg b.i.d. (8 X 50 mg tablets), oral administration; Esomeprazole, tablet, 40 mg b.i.d. (1 X 40 mg tablet), oral administration

Timeline

• Start date: 2008-09-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2008-07-28
• Last updated: 2009-06-16

Locations

1 site across 1 country: Germany