A clinical study, which evaluates the effectiveness and the safety of a new medication for prostatic hyperplasia, silodosin, when administered under normal conditions of use in a wide European population.
- Conditions
- Benign prostatic hyperplasia.MedDRA version: 14.1Level: PTClassification code 10004446Term: Benign prostatic hyperplasiaSystem Organ Class: 10038604 - Reproductive system and breast disordersTherapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
- Registration Number
- EUCTR2011-000045-20-ES
- Lead Sponsor
- RECORDATI S.p.A
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 0
- Clinical diagnosis of BPH by the urologist;
- Male subjects aged 60 years or older;
- IPSS total score ?12 at Visit 1 (Screening) and 2 (Baseline);
- Able to comply with protocol procedures;
- Written informed consent obtained before beginning any investigational procedures.
- Untreated patients or patients not adequately controlled or intolerant to current therapy for LUTS/BPH. Patients on current therapy with 5-alpha inhibitors (5-ARI) for whom, in the opinion of the investigator, a combined therapy is indicated, may be included.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 700
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 300
- Hypersensitivity to the active substance or to any of the excipients;
- Patients for whom cataract surgery is scheduled;
- History of orthostatic hypotension or syncope;
- Moderate or severe renal impairment (CLCR <50 ml/min, as estimated by the Cockcroft Gault formula);
- Severe hepatic impairment;
- Concomitant use of other ?-adrenoreceptor antagonists or natural/herbal products known to have an effect on LUTS (e.g. saw palmetto - serenoa serulata/repens) . Patients already on treatment with those drugs may be enrolled after a 4 week wash-out period before Visit 2 (baseline);
- Concomitant use with potent CYP3A4 inhibitors, such as ketoconazole, itraconazole or ritonavir (possible PK interaction);
- Prostate cancer;
- History of prostate or bladder neck surgery, including TURP, TUNA, laser or other minimally invasive therapy;
- Active urinary tract infection;
- Acute or recurrent prostatitis (more than 3 times in the last year);
- History of neurological disease that may affect bladder function;
- Unstable cardiovascular or cerebrovascular disease (including acute myocardial infarction, unstable angina pectoris, by-pass, PTCA, congestive heart failure class III-IV, stroke, transient ischemic attack and episodes of cardiac arrhythmia requiring treatment in the last 6 months);
- History or current evidence of drug or alcohol abuse within the last 12 months;
- Participation in a study involving the administration of an investigational compound within the past 30 days;
- Any other condition which, in the investigator's judgement, renders the subject unable to complete the study or increases the risk to the subject or which prevents optimal participation in achieving the objectives of the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objective of the study is to confirm in a larger and less selected population (?real life conditions?) the positive risk-benefit balance observed with silodosin 8 mg in double-blind, randomised clinical trials.;Secondary Objective: The effectiveness and safety of the drug will be investigated also in different subgroups of subjects according to age, severity of the disease, concomitant disease and medications.;Primary end point(s): The primary objective of the study is to evaluate the effect of silodocin on LUTS in terms of IPSS response rate (decrease from baseline >=25% in the IPSS total score);Timepoint(s) of evaluation of this end point: - Baseline to week +24.<br>- Baseline to week +52 (only Spanish patients)
- Secondary Outcome Measures
Name Time Method Secondary end point(s): The secondary objectives are:<br>- effects on LUTS <br>- effects on QoL due to urinary symptoms<br>- safety profile<br>- adherence to therapy<br>- patient?s treatment satisfaction;Timepoint(s) of evaluation of this end point: - Baseline to week +24, follow-up information will be collected up to 4 - weeks by a phone contact.<br>- Baseline to week +52, follow-up information will be collected up to 4 weeks by a phone contact (only Spanish patients).