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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00723502
Recruitment Status : Completed
First Posted : July 28, 2008
Last Update Posted : June 16, 2009
Information provided by:
MerLion Pharmaceuticals GmbH

Brief 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.

Condition or disease Intervention/treatment Phase
Gram-Negative Bacterial Infections Helicobacter Infections Dyspepsia Drug: Finafloxacin + Amoxicillin Drug: Finafloxacin + Esomeprazole Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : September 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Eradication of Helicobacter pylori [ Time Frame: 14 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Male or female patients of 18 to 70 years old, with dyspepsia or dyspeptic symptoms.
  2. The patient must understand the nature of the study and must provide written informed consent.
  3. Each patient must be able to communicate with study personnel.
  4. Gastroscopic confirmation of H. pylori infection by Rapid Urease Test.
  5. Positive Urea Breath Test.
  6. Absence of blood in stools.

Exclusion Criteria:

  1. Gastroscopic confirmation of gastric ulcers.
  2. History of Zollinger-Ellison syndrome.
  3. Gastroesophageal Reflux Disease (GERD).
  4. Subtotal gastrectomy or vagotomy in medical history.
  5. Pyloric stenosis.
  6. Previous H. pylori eradication therapy.
  7. Patients likely to need to take one of the following medication within two weeks prior to and during the study period:

    • any other antibiotic than the study medication;
    • any other proton-pump inhibitor than the study medication;
    • NSAIDs including aspirin and glucocorticoids;
  8. Patients taking antacids and/or H2-blockers during the study period.
  9. Patients taking bismuth compound within four weeks prior to and during the study period.
  10. Patients with psychiatric, neurological, or behavioral disorders that may interfere with the conduct or interpretation of the study.
  11. Patients with severe concomitant disease of the cardiovascular, pulmonic, hepatic, renal, hematological, lymphatic, metabolic, and endocrine system.
  12. Clinically significant serious unstable physical illness: treated, controlled and thus stable hypertension is not considered an exclusion criterion.
  13. Patients with known uncontrolled hypertension or symptomatic hypotension.
  14. Patients who are immunocompromised.
  15. Patients with malignant disease of any kind except Basalioma.
  16. Patients showing clinically significant abnormal vital signs.
  17. Patients with clinically significant abnormal ECG findings.
  18. Clinically significant abnormal laboratory data at Screening, or any abnormal laboratory value that could interfere with the assessment of safety.
  19. Exposure to any investigational drug within 30 days prior Screening.
  20. Known hypersensitivity or contraindication to the use of fluoroquinolones.
  21. Prior participation in Finafloxacin study.
  22. Pregnant or nursing woman, or woman of childbearing potential who is not using an effective contraceptive method during the study, e.g. oral (stable doses for at least three months prior to Screening) or injectable (stable doses for at least two months prior to Screening) contraceptives, implantation of levonorgestrel system and intrauterine devices (for at least two months prior Screening), barrier methods (combination of diaphragm and spermicide or condom and spermicide).
  23. Current diagnosis or known history of substance abuse.
  24. Site personnel and their immediate families, defined as their spouse, parent, child, grandparent, or grandchild.
  25. Reasonable likelihood for non-compliance with the protocol or any other reason that, in the investigator's opinion, prohibits the inclusion of the patient into the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00723502

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Dr. Hein
Marburg, Germany, 35037
Sponsors and Collaborators
MerLion Pharmaceuticals GmbH
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Principal Investigator: Peter Malfertheiner, MD, Director Not affiliated
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Responsible Party: Prof. Dr. P. Malfertheiner, Director, Hospiltal for Gastroenterology and Hepatology Identifier: NCT00723502    
Other Study ID Numbers: FINA-002
First Posted: July 28, 2008    Key Record Dates
Last Update Posted: June 16, 2009
Last Verified: October 2008
Keywords provided by MerLion Pharmaceuticals GmbH:
Helicobacter pylori
Additional relevant MeSH terms:
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Communicable Diseases
Bacterial Infections
Gram-Negative Bacterial Infections
Helicobacter Infections
Signs and Symptoms, Digestive
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Antineoplastic Agents
Nucleic Acid Synthesis Inhibitors