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

NCT ID: NCT00723502

Last Updated: 2009-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2009-04-30

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.

Conditions

Gram-Negative Bacterial Infections; Helicobacter Infections; Dyspepsia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

Finafloxacin + Amoxicillin

Intervention Type: DRUG

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

2

Group Type: EXPERIMENTAL

Finafloxacin + Esomeprazole

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Not apllicable

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MerLion Pharmaceuticals GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Hospiltal for Gastroenterology and Hepatology

Principal Investigators

Peter Malfertheiner, MD, Director

Role: PRINCIPAL_INVESTIGATOR

Not affiliated

Locations

Dr. Hein

Marburg, , Germany

Countries

Germany

Other Identifiers

FINA-002

Identifier Type: -

Identifier Source: org_study_id