An open-label, randomized, multicenter, two-arm efficacy and safety study of 14 daystreatment 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 withHelicobacter pylori infectionFinafloxacin in patients with Helicobacter: FLASH study - FLASH

• Conditions: Helicobacter pylori infection; MedDRA version: 9.1Level: LLTClassification code 10019377Term: Helicobacter pylori infection

• Registration Number: EUCTR2007-007749-11-DE
• Lead Sponsor: MerLion Pharmaceuticals GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08-05
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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, hematologic, 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 & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the H. pylori eradication rates with Finafloxacin in combination with Amoxicillin or Esomeprazole.;Secondary Objective: To evaluate and compare the safety and tolerability of multiple oral doses of Finafloxacin plus Amoxicillin versus Finafloxacin plus Esomeprazole. ;Primary end point(s): The primary efficacy endpoint is the H. pylori eradication rate during the course of the<br>study in the Finafloxacin plus Amoxicillin and Finafloxacin plus Esomeprazole arms.