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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00723502
Other study ID # FINA-002
Secondary ID
Status Completed
Phase Phase 2
First received July 25, 2008
Last updated June 15, 2009
Start date September 2008
Est. completion date April 2009

Study information

Verified date October 2008
Source MerLion Pharmaceuticals GmbH
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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.


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Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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
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

Locations

Country Name City State
Germany Dr. Hein Marburg

Sponsors (1)

Lead Sponsor Collaborator
MerLion Pharmaceuticals GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Eradication of Helicobacter pylori 14 days Yes
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