An Open-label, Randomised, Multicentre, Multi-country Three-arm Study of the Treatment with Finafloxacin 400 mg b.i.d. plus Esomeprazole 40 mg b.i.d. for 14 days versus Finafloxacin 400 mg b.i.d. plus Esomeprazole 40 mg b.i.d. plus Amoxicillin 1000 mg b.i.d. for 10 days versus Clarithromycin 500 mg b.i.d. plus Amoxicillin 1000 mg b.i.d. plus Esomeprazole 40 mg b.i.d. for 10 Days in Patients with Helicobacter pylori infection. Finafloxacin in patients with Helicobacter: The FLASH 2 Study - FLASH 2 Study

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

• Registration Number: EUCTR2009-011865-10-LV
• Lead Sponsor: MerLion Pharmaceuticals GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08-03
• Last Update Posted: 24 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

1. Male or female subjects of 18 to 70 years old.
2. Presence of dyspepsia or dyspeptic symptoms.
3. Able to understand the nature of the study and provide written informed consent.
4. Able to communicate with study personnel.
5. Gastroscopic confirmation of H. pylori infection by Rapid Urease Tests.
6. Positive Urea Breath Test.
7. 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 and/or duodenal ulcers.
2. History of Zollinger-Ellison syndrome.
3. Gastroesophageal Reflux Disease (GERD) with Los Angeles classification grade C or D (Appendix 1).
4. Subtotal gastrectomy or vagotomy in medical history.
5. Pyloric stenosis.
6. Previous H. pylori eradication therapy.
7. Likely to require one of the following medications within two weeks prior to or during the study period:
• any other antibiotic than the study medication;
• any other proton-pump inhibitor than the study medication;
• antacids (only forbidden during the medication phase);
• H2 blockers.
8. Bismuth compounds used within four weeks prior to, or during, the study period.
9. Psychiatric, neurological or behavioural disorders that may interfere with the conduct or interpretation of the study.
10. Severe concomitant disease of the cardiovascular, pulmonary, hepatic, renal, haematological, lymphatic, metabolic or endocrine system (controlled diabetes is allowed).
11. Clinically relevant serious unstable physical illness: treated, controlled and thus stable hypertension is not considered an exclusion criterion.
12. Known uncontrolled hypertension or symptomatic hypotension.
13. Subjects who are immunocompromised.
14. Malignant disease of any kind except basalioma.
15. Clinically relevant abnormal vital signs.
16. Clinically relevant abnormal ECG findings.
17. Clinically relevant abnormal laboratory data at screening, or any abnormal laboratory value that could interfere with the assessment of safety.
18. Exposure to any investigational drug within 30 days prior Screening.
19. Known hypersensitivity or other contraindication to the use of fluoroquinolones and other study medication.
20. Prior participation in finafloxacin studies.
21. Pregnant or nursing women. Women of childbearing potential must use effective contraception 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, implanted levonorgestrel contraceptives, intrauterine devices (for at least two months prior to screening) and/or barrier methods (combination of diaphragm and spermicide, or condom and spermicide), sexual abstinence or vasectomised partner.
22. Current diagnosis or known history of substance abuse.
23. Site personnel and their immediate families; defined as their spouse, parent, child, grandparent or grandchild.
24. Reasonable likelihood for non-compliance with the protocol or any other reason that, in the investigator’s opinion, prohibits the inclusion of the subject into the study.

Study & Design

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