Helicobacter pylori infection MedDRA version: 9.1 Level: LLT Classification code 10019377 Term: Helicobacter pylori infection
Conditions
Interventions
Product Name: Finafloxacin
Product Code: FINA
Pharmaceutical Form: Tablet
INN or Proposed INN: Finafloxacin
CAS Number: 209342-40-5
Current Sponsor code: FINA
Concentration unit: mg milligram(s)
Conce
Sponsors
MerLion Pharmaceuticals GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the eradication rates of H. pylori of the therapy with finafloxacin in combination with esomeprazole and with finafloxacin plus esomeprazole plus amoxicillin compared with standard triple therapy.;Secondary Objective: One secondary objective is to compare the safety and tolerability of multiple oral doses of finafloxacin plus esomeprazole and finafloxacin plus esomeprazole plus amoxicillin in comparison to standard triple therapy by assessing adverse events, physical examinations, standard laboratory parameters, and ECG. As an additional secondary objective, microbiological characterisation of H. pylori isolated from all patients prior to therapy and from those with a positive UBT at Day 50 ± 5 will be performed, including susceptibility profiling to finafloxacin and to antibiotics commonly used for H. pylori therapy.;Primary end point(s): The primary efficacy endpoint is the eradication of H. pylori confirmed by UBT in subjects by the day 50 ± 5 assessment. | — |
Countries
Germany, Latvia, Lithuania, Poland
Outcome results
None listed