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

Primary Purpose

Gram-Negative Bacterial Infections, Helicobacter Infections, Dyspepsia

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Finafloxacin + Amoxicillin
Finafloxacin + Esomeprazole
Sponsored by
MerLion Pharmaceuticals GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gram-Negative Bacterial Infections focused on measuring Helicobacter pylori, Eradication, Dyspepsia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dr. Hein

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Eradication of Helicobacter pylori

Secondary Outcome Measures

Full Information

First Posted
July 25, 2008
Last Updated
June 15, 2009
Sponsor
MerLion Pharmaceuticals GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT00723502
Brief Title
Efficacy and Safety Study of Finafloxacin Used in Helicobacter Pylori Infected Patients
Acronym
FLASH
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 Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
MerLion Pharmaceuticals GmbH

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gram-Negative Bacterial Infections, Helicobacter Infections, Dyspepsia
Keywords
Helicobacter pylori, Eradication, Dyspepsia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Finafloxacin + Amoxicillin
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Finafloxacin + Esomeprazole
Other Intervention Name(s)
Not apllicable
Intervention Description
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
Primary Outcome Measure Information:
Title
Eradication of Helicobacter pylori
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female patients of 18 to 70 years old, with dyspepsia or dyspeptic symptoms. The patient must understand the nature of the study and must provide written informed consent. Each patient must be able to communicate with study personnel. Gastroscopic confirmation of H. pylori infection by Rapid Urease Test. Positive Urea Breath Test. Absence of blood in stools. Exclusion Criteria: Gastroscopic confirmation of gastric ulcers. History of Zollinger-Ellison syndrome. Gastroesophageal Reflux Disease (GERD). Subtotal gastrectomy or vagotomy in medical history. Pyloric stenosis. Previous H. pylori eradication therapy. 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; Patients taking antacids and/or H2-blockers during the study period. Patients taking bismuth compound within four weeks prior to and during the study period. Patients with psychiatric, neurological, or behavioral disorders that may interfere with the conduct or interpretation of the study. Patients with severe concomitant disease of the cardiovascular, pulmonic, hepatic, renal, hematological, lymphatic, metabolic, and endocrine system. Clinically significant serious unstable physical illness: treated, controlled and thus stable hypertension is not considered an exclusion criterion. Patients with known uncontrolled hypertension or symptomatic hypotension. Patients who are immunocompromised. Patients with malignant disease of any kind except Basalioma. Patients showing clinically significant abnormal vital signs. Patients with clinically significant abnormal ECG findings. Clinically significant abnormal laboratory data at Screening, or any abnormal laboratory value that could interfere with the assessment of safety. Exposure to any investigational drug within 30 days prior Screening. Known hypersensitivity or contraindication to the use of fluoroquinolones. Prior participation in Finafloxacin study. 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). Current diagnosis or known history of substance abuse. Site personnel and their immediate families, defined as their spouse, parent, child, grandparent, or grandchild. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Malfertheiner, MD, Director
Organizational Affiliation
Not affiliated
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Hein
City
Marburg
ZIP/Postal Code
35037
Country
Germany

12. IPD Sharing Statement

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

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