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

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

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.

Study Overview

• Status: Completed
• Conditions: Dyspepsia; Gram-Negative Bacterial Infections; Helicobacter Infections
• Intervention / Treatment: Drug: Finafloxacin + Amoxicillin; Drug: Finafloxacin + Esomeprazole

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Marburg, Germany, 35037
    • Dr. Hein

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Not apllicable

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Eradication of Helicobacter pylori	14 days

Collaborators and Investigators

• Sponsor: MerLion Pharmaceuticals GmbH
• Investigators: Principal Investigator: Peter Malfertheiner, MD, Director, Not Affiliated

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): April 1, 2009
• Study Completion (Actual): April 1, 2009

Study Registration Dates

• First Submitted: July 25, 2008
• First Submitted That Met QC Criteria: July 25, 2008
• First Posted (Estimate): July 28, 2008

Study Record Updates

• Last Update Posted (Estimate): June 16, 2009
• Last Update Submitted That Met QC Criteria: June 15, 2009
• Last Verified: October 1, 2008

More Information

Terms related to this study

• Keywords: Helicobacter pylori; Eradication; Dyspepsia
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Signs and Symptoms, Digestive; Bacterial Infections and Mycoses; Dyspepsia; Infections; Communicable Diseases; Helicobacter Infections; Bacterial Infections; Gram-Negative Bacterial Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Gastrointestinal Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Anti-Infective Agents, Urinary; Renal Agents; Amoxicillin; Fluoroquinolones; Esomeprazole; Finafloxacin
• Other Study ID Numbers: FINA-002