Official Title: “A Double-Blind, Double-Dummy, Prospective, Randomized Multiple-Site Study of Oral Finafloxacin 300 mg b.i.d. Versus Oral Ciprofloxacin 250 mg b.i.d. in Patients With Lower Uncomplicated UTI (uUTI) With a Treatment Duration of 3 Days”

To compare the bacteriological eradication rates of Finafloxacin and Ciprofloxacin in female patients with uUTI.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: April 2009

Patients with clinical signs and symptoms of uUTI who have a high probability of the required number of bacteria in their urine, measured by positive test for nitrite and /or leucocyte esterase by means of a dipstick will be enrolled in this study. Only these patients with bacterial count equal or more than 10e5 cfu/mL will be included in the efficacy analysis. At Baseline, patients will be randomly assigned (2:1) to receive Finafloxacin 300 mg or Ciprofloxacin 250 mg, following a double-dummy design, ie Group 1 will receive Finafloxacin tablets + Ciprofloxacin placebo capsule while Group II will receive Ciprofloxacin capsule + Finafloxacin placebo tablets. The treatment will last in total 3 days. The microbiological results will be compared with the baseline microbiology. If the concentration of initial pathogen in the urine is equal or more than 10e3 cfu/mL in the post-therapy culture compared with the baseline , this will define a bacteriological eradication. Microbiological assessment will be performed as well. Evaluation of the bacteria reinfection or relapse will be performed, based on the microbiology results. The status of clinical improvement and cure will be considered additionally.

Intervention(s) in this Clinical Trial

• Drug: Finafloxacin
  • Finafloxacin tablets, 300 mg b.i.d., oral administration; Ciprofloxacin placebo capsule, 1 capsule b.i.d.,oral administration; duration: 3 days
• Drug: Ciprofloxacin
  • Finafloxacin placebo, 6 tablets b.i.d., oral administration; Ciprofloxacin capsule, 250 mg b.i.d., oral administration; duration: 3 days

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Group I: Finafloxacin tablets + Ciprofloxacin placebo capsule
• Active Comparator: 2
  • Group II: Ciprofloxacin capsule + Finafloxacin placebo tablets

Primary Measures

• Bacteriological eradication of the initial pathogen.
  • Time Frame: 4-6 days
    Safety Issue?: Yes

Secondary Measures

• Clinical cure: Absence of signs or symptoms of uUTI.
  • Time Frame: 10-14 days
    Safety Issue?: Yes

Inclusion Criteria:

• 1. Female patients between 18 and 55 years with uUTI.
• 2. Two of the following sign and symptoms of uUTI: dysuria, frequency, urgency, miction pain, suprapubic pain, gross hematuria, turbid urine or malodorous urine.
• 3. Able to supply a mid-stream, clean catch urine sample for microbiological analysis.
• 4. The result of the dipstick should indicate a high probability of the required number of bacteria.
• 5. Be able to communicate with the study personnel.
• 6. Has given written consent to participate in the study.

Exclusion Criteria:

• 1. Female patients having signs and symptoms of upper urinary tract infection (e.g.
• fever, flank pain) indicating complicated UTI.
• 2. Male patients
• 3. History or evidence of other functional or anatomical abnormalities of the urinary tract (e.g. acute pyelonephritis), diabetes mellitus and immunosuppression.
• 4. Recurrent cystitis with more than 3 episodes in the past 12 months.
• 5. Clinical symptoms for more than 7 days before Baseline.
• 6. Psychiatric, neurological or behavior disorders.
• 7. Clinically significant serious unstable physical illness.
• 8. Known uncontrolled condition of hypertension or symptomatic hypotension, known ischemic heart disease or history of myocardial infarction (within 12 months prior study enrolment), coronary artery bypass surgery or percutaneous transluminal coronary angioplasty.
• 9. Existence of any surgical or medical condition which might interfere with the distribution, metabolism or excretion of the drug, i.e. impaired renal or hepatic function, diabetes mellitus, chronic symptoms of pronounced constipation or diarrhea or conditions associated with total or partial obstruction of the urinary tract.
• 10. Antibiotic intake 2 weeks before study enrolment.
• 11. Failed UTI therapy within 2 months before study inclusion.
• 12. Expectancy of concomitant administration of antibiotics, sucralfate or divalent and trivalent cations such as iron or antacids containing magnesium, aluminium or calcium intake during the course of the study.
• 13. Clinically abnormal vital signs, ECG findings and safety laboratory results at
• Baseline.
• 14. Known hypersensitivity or contraindication to the use of fluoroquinolones.
• 15. History of tendon lesions or ruptures during quinolone treatment.
• 16. Any malignant disease or a history of malignant neoplasm other than carcinoma in situ of the cervix or basal cell carcinoma of the skin, within the last 5 years before
• Baseline.
• 17. Current diagnosis or history of substance abuse.
• 18. Exposure to any of the investigational drugs 30 days prior to Baseline.
• 19. 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 3 months prior to Baseline) or injectable (stable doses for at least 2 months prior to Baseline) contraceptives, intrauterine devices (for at least 2 months prior Baseline), double-barrier method, contraceptive patch, female sterilization or condoms.
• 20. The patient, planned to be enrolled is an employee of any involved study investigator or any involved institution including the study sponsor.
• 21. Inability or lacking motivation to participate in the study.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: MerLion Pharmaceuticals GmbH

Overall Clinical Trial Officials and Contacts

Jasper Hein, MD Principal Investigator Unaffiliated  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00722735

Study ID Number: FINA-003

ClinicalTrials.gov Identifier: NCT00722735

Health Authority: Germany: Federal Institute for Drugs and Medical Devices