Chronic Bacterial Prostatitis (CBP) MedDRA version: 18.0 Level: PT Classification code 10069918 Term: Bacterial prostatitis System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: UNIDROX - 600 MG COMPRESSE RIVESTITE CON FILM 10 COMPRESSE
Product Name: prulifloxacina
Product Code: 027
Pharmaceutical Form: Coated tablet
Trade Name: LEVOXACIN - 500 MG COMPRESSE RIV
Sponsors
AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO A.C.R.A.F. S.P.A.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Male between 18 and 50 years of age (limited included) with no limitation of race. 2. Patients presenting symptoms of prostatitis for at least 3 months. 3. Laboratory evidence of CBP at Visit 0 (Screening), assessed by Meares&Stamey four-glass test and defined as: a. VB3 or EPS specimen containing =100 colony-forming units/ml of pathogen/s if the VB2 specimen is sterile; or b. VB3 or EPS specimen containing =100 colony-forming units/ml of pathogen/s that is different from any present in the VB2. 4. Medications for chronic prostatitis and/or medications that may affect bladder or prostate function (including but not limited to hormone therapy, anticholinergic or alpha blocker) must be discontinued at least 7 days before study drug intake. 5. Patients legally capable to give their consent to participate the study, and available to sign and date the written informed consent. 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 148 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity or allergy to antibacterial fluoroquinolones and or to any components of the study medications. 2. Pathogen/s resistant to the study drugs at Visit 0 (Screening). 3. Suspicion for prostatic cancer, neurogenic bladder, Benign Prostatic Hypertrophy (BPH), bladder neck obstruction or urethral stricture. 4. Body Mass Index (BMI) 3 times the upper boundary of the normal ranges. 9. Value of creatinine outside the normal ranges and judged clinically relevant by Investigator. 10. History of cardiac disease, including but not limited to myocardial infarction, heart failure, cardiomyopathy, cardiac hypertrophy, cardiac arrhythmias, bradycardia, cardiac conduction abnormalities, long QT syndrome. 11. Value of electrolytes (sodium, potassium, calcium, magnesium, chloride) outside the normal ranges and judged clinically relevant by Investigator. 12. Patients under treatment with medications that may cause increase of the QT interval. 13. History of tendinopathy. 14. Patients with latent or known deficiencies for the glucose-6-phosphate dehydrogenase, or with hereditary problems of galactose intolerance or the Lapp lactase deficiency or glucose-galactose malabsorption. 15. Recent or past history of psychiatric illness or epilepsy. 16. Treatment with antibiotics or antibacterials within 2 weeks before study drug intake. 17. Treatment with experimental drugs (prulifloxacin or levofloxacin) or other fluoroquinolones within 4 weeks before study drug intake. 18. Diabetic patients in treatment with oral hypoglycemic drugs and insulin. 19. Patients under treatment with corticosteroids or Non-Steroidal Antiflammatory Drugs (NSAIDs). 20. Concomitant treatment with xanthines or anticoagulant drugs or drugs producing hypokalemia or diuretics. 21. Positive history for drugs and alcohol abuse. 22. Inability to comply with the protocol requirements, instructions or study-related restrictions (i.e. uncooperative attitude, inability to return for study-visits, improbability of completing the clinical study). 23. Vulnerable subjects (i.e. persons kept in detention). 24. Subject involved in the conduct of the study (i.e. Investigator or his/her deputy, first grade relatives, pharmacist, assistant or other personnel). 25. Participation to an interventional clinical trial within 3 months prior to Visit 0 (Screening Visit).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy and safety of prulifloxacin in comparison to levofloxacin in the treatment of patients affected by Chronic Bacterial Prostatitis (CBP).;Secondary Objective: NA;Primary end point(s): The microbiological efficacy assessed as eradication of prulifloxacin in comparison to levofloxacin.;Timepoint(s) of evaluation of this end point: Visit 3 (TOC Visit), 7 days (±2) after the end of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 1 Visit 4 (3 months after the end of treatment ±5 days). 2 Visit 5 (6 months after the end of treatment ±5 days). 3 Visit 3 (TOC Visit, 7 days (±2 days) after EOT). 4 Visit 4 (3 months after the EOT ±5 days). 5 Visit 5 (6 months after the EOT ±5 days). 6 During the study.;Secondary end point(s): 1 The microbiological efficacy assessed as eradication. 2 The microbiological efficacy assessed as eradication. 3 The clinical efficacy as assessed by NIH-CPSI reduction respect to Screening visit. 4 he clinical efficacy as assessed by NIH-CPSI reduction respect to Screening visit. 5 The clinical efficacy as assessed by NIH-CPSI reduction respect to Screening visit. 6 The safety and tolerability. | — |
Countries
Greece, Italy
Contacts
Public ContactCTA unit
AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO A.C.R.A.F. S.P.A.
Outcome results
None listed