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.

Effectiveness and safety of silodosin in the treatment of LUTS in patients with benign prostatic hyperplasia: a European phase IV clinical study (the Silodosin in Real-life Evaluation study) - SIRE

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-000045-20-DE

Enrollment

1000

Registered

2011-03-30

Start date

2011-08-02

Completion date

Unknown

Last updated

2014-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign prostatic hyperplasia. MedDRA version: 13.1 Level: PT Classification code 10004446 Term: Benign prostatic hyperplasia System Organ Class: 10038604 - Reproductive system and breast disorders

Interventions

Trade Name: Urorec® Product Name: Urorec® Product Code: Silodosin Pharmaceutical Form: Capsule, hard CAS Number: 160970-54-7 Current Sponsor code: KMD-3212 Other descriptive name: SILODOSIN Concentrat

Eligibility

Sex/Gender

Male

Inclusion criteria

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. 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

Exclusion criteria

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 a-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.

Design outcomes

Primary

Measure	Time frame
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 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.	—

Measure

Time frame

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 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.

—

Secondary

Measure	Time frame
Secondary end point(s): The secondary objectives are: - effects on LUTS expressed as - effects on QoL due to urinary symptoms - safety profile - adherence to therapy - 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.	—

Countries

Germany, Hungary, Ireland, Italy, Portugal, Romania, Spain, United Kingdom

Contacts

Public ContactDr. Massimo Casi

RECORDATI S.p.A

casi.m@recordati.it3902487871

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026