E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Benign prostatic hyperplasia. |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Male diseases of the urinary and reproductive systems [C12] |
MedDRA Classification |
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 |
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 in double-blind, randomised clinical trials. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
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. |
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E.4 | Principal exclusion criteria |
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 α-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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary efficacy parameter: The International Prostate Symptom Score (IPSS) is a validated questionnaire designed to quantify the symptoms encountered most frequently with BPH (incomplete emptying, frequency, intermittency, urgency, weak stream, hesitancy and nocturia) (Barry 1992), and it has become the international standard (de la Rosette et al. 2009). Questions 1-6 are graded on a 6-point scale with 0 = "not at all" and 5 = "almost always". For question 7, the descriptors are 0 = "none" to 5 = "5 or more times". The total score (questions 1 to 7) is a sum of each question's result. For question 8, evaluating the subject's quality of life due to urinary symptoms, the descriptors are 0 = "delighted" to 6 = " terrible". The primary efficacy parameter will be the percentage of treatment responders at study end (defined as subjects with a decrease ≥ 25% as compared to baseline in the IPSS total score). The IPSS questionnaire will be filled in at visit 1 and visit 2 (entry criteria and baseline value), visit 3, visit 4 and visit 5 or in case of premature discontinuation (see Appendix 15.5). Validated local translations will be used in each country. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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). |
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E.5.2 | Secondary end point(s) |
The following aspects will be evaluated:
- effects on LUTS
- effects of QoL due to urinary symptoms
- safety profile
- adherence to therapy
- patient's treatment satisfaction. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Expressed as:
- Subjects with a clinically relevant (> 3 points) decrease in IPSS total score from baseline;
- Change from baseline in IPSS total score, storage and voiding subscores;
- Percentage of subjects improving each symptom of the ICS male questionnaire as compared to baseline;
- Percentage of subjects showing an improvement in the symptoms perceived as most bothersome at baseline;
- Change from baseline in No. of voids (day/night/24 hours)
- Change from baseline in Urine volume (day/night/24 hours)
- Change from baseline in voided volume (min/max/mean).
· effects on QoL due to urinary symptoms
- Change from baseline in IPSS Question 8.
· safety profile
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Information not present in EudraCT |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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 | 100 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 100 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
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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Last visit of the last patient. |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 5 |
E.8.9.2 | In all countries concerned by the trial days | 0 |