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

This study has been completed.
Sponsor:
Information provided by:
MerLion Pharmaceuticals GmbH
ClinicalTrials.gov Identifier:
NCT00723502
First received: July 25, 2008
Last updated: June 15, 2009
Last verified: October 2008
  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 2

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

Resource links provided by NLM:


Further study details as provided by MerLion Pharmaceuticals GmbH:

Primary Outcome Measures:
  • Eradication of Helicobacter pylori [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

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
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00723502

Locations
Germany
Dr. Hein
Marburg, Germany, 35037
Sponsors and Collaborators
MerLion Pharmaceuticals GmbH
Investigators
Principal Investigator: Peter Malfertheiner, MD, Director Not affiliated
  More Information

No publications provided

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

Keywords provided by MerLion Pharmaceuticals GmbH:
Helicobacter pylori
Eradication
Dyspepsia

Additional relevant MeSH terms:
Bacterial Infections
Dyspepsia
Helicobacter Infections
Gram-Negative Bacterial Infections
Signs and Symptoms, Digestive
Signs and Symptoms
Amoxicillin
Fluoroquinolones
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014