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

NCT00723502 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2009-06-16

No results posted yet for this study

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

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

Sponsors & Collaborators

  • MerLion Pharmaceuticals GmbH

    lead INDUSTRY

Principal Investigators

  • Peter Malfertheiner, MD, Director · Not affiliated

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2009-04-30
Completion
2009-04-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00723502 on ClinicalTrials.gov