E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Lower uncomplicated Urinary Tract Infection |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10046571 |
E.1.2 | Term | Urinary tract infection |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To compare the bacteriological eradication rates of Finafloxacin and Ciprofloxacin in female patients with uUTI. |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
APPENDIX IV: Instructions for additional PK sampling in Singapore Study Protocol, FINA-003, Appendix IV, Final Version 1.0, 14-MAR-2008 |
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E.3 | Principal 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.
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E.4 | Principal 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 immunosuppresion. 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 behaviour 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, aluminum or calcium intake during the course of the study.. 13.Clinically abnormal vital signs and ECG findings at Baseline; clinically relevant abnormal findings from the safety laboratory collected 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
Bacteriological eradication of the initial pathogen (≤10exp.3) at Day 4-6 (Visit 3). |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 5 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 3 |