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| Sponsor: | MerLion Pharmaceuticals GmbH |
|---|---|
| Information provided by: | MerLion Pharmaceuticals GmbH |
| ClinicalTrials.gov Identifier: | NCT00723502 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Gram-Negative Bacterial Infections Helicobacter Infections Dyspepsia |
Drug: Finafloxacin + Amoxicillin Drug: Finafloxacin + Esomeprazole |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
| Estimated Enrollment: | 30 |
| Study Start Date: | September 2008 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
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
|
| Experimental: 2 |
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
Other Name: Not apllicable
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Patients likely to need to take one of the following medication within two weeks prior to and during the study period:
Contacts and Locations
More Information
| Responsible Party: | Prof. Dr. P. Malfertheiner, Director, Hospiltal for Gastroenterology and Hepatology |
| ClinicalTrials.gov Identifier: | NCT00723502 History of Changes |
| Other Study ID Numbers: | FINA-002 |
| Study First Received: | July 25, 2008 |
| Last Updated: | June 15, 2009 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
Helicobacter pylori Eradication Dyspepsia |
|
Bacterial Infections Dyspepsia Helicobacter Infections Gram-Negative Bacterial Infections Signs and Symptoms, Digestive Signs and Symptoms Amoxicillin Fluoroquinolones Omeprazole |
Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Anti-Ulcer Agents Gastrointestinal Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Nucleic Acid Synthesis Inhibitors |