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

Dyspepsia Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00723502
• Other study ID #: FINA-002
• Status: Completed
• Phase: Phase 2
• First received: July 25, 2008
• Last updated: June 15, 2009
• Start date: September 2008
• Est. completion date: April 2009

Study information

• Verified date: October 2008
• Source: MerLion Pharmaceuticals GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bacterial Infections
• Communicable Diseases
• Dyspepsia
• Gram-Negative Bacterial Infections
• Helicobacter Infections
• Infection

Intervention

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
• 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

Locations

Country	Name	City	State
Germany	Dr. Hein	Marburg

Sponsors (1)

Lead Sponsor	Collaborator
MerLion Pharmaceuticals GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eradication of Helicobacter pylori		14 days	Yes