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Effectiveness and Safety of Silodosin in the Treatment of Benign Prostatic Hyperplasia (SiRE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01757769
Recruitment Status : Completed
First Posted : December 31, 2012
Last Update Posted : April 29, 2014
Information provided by (Responsible Party):

Brief Summary:
The purpose of this study is to confirm in a larger population in Europe the effectiveness and safety observed with silodosin in previous clinical trials.

Condition or disease Intervention/treatment Phase
Benign Prostatic Hyperplasia Drug: Silodosin Phase 4

Detailed Description:

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.

The following aspects will be evaluated:

  • the effects on lower urinary tract symptoms (LUTS), by means of the International Prostate Symptoms Score (IPSS) questionnaire
  • the effect on the most frequent and bothersome symptoms, by means of International Continence Society (ICS)-male questionnaire
  • the effects on Quality of Life (QoL) due to urinary symptoms
  • the safety profile
  • the adherence to therapy
  • the patient satisfaction with treatment 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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1036 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2011
Actual Primary Completion Date : March 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Silodosin

Arm Intervention/treatment
Experimental: Silodosin
Silodosin capsule 8 mg daily for 24 weeks
Drug: Silodosin
8 mg daily for 24 weeks

Primary Outcome Measures :
  1. The primary objective of the study is to evaluate the effects of silodosin on LUTS in terms of IPSS response rate (decrease from baseline ≥ 25% in the IPSS total score) [ Time Frame: 6 months o treatment ]

Secondary Outcome Measures :
  1. Change from baseline in IPSS total score [ Time Frame: 4, 12, 24 weeks of treatment ]

Other Outcome Measures:
  1. Percentage of subjects improving each symptom of the ICS (International Continence Society) male questionnaire as compared to baseline; to evaluate the effect of silodosin on the most frequent and bothersome symptoms [ Time Frame: 6 months of treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Clinical diagnosis of Benign Prostatic Hyperplasia (BPH) by the urologist;
  • Male subjects aged 60 years or older;
  • IPSS total score equal or more than 12 at Visit 1 (Screening) and 2 (Baseline);
  • Able to comply with protocol procedures;
  • Written informed consent obtained before beginning any investigational procedures.

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 serrulate/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 cytochrome P450 3A4 inhibitors, such as ketoconazole, itraconazole or ritonavir (possible pharmacokinetic interaction);
  • Prostate cancer;
  • History of prostate or bladder neck surgery, including transurethral prostatectomy, 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, percutaneous transluminal coronary angioplasty, 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01757769

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Vita e Salute University, Department of Urology, Istituto Scientifico Ospedale San Raffaele
Milan, Italy, 20132
Sponsors and Collaborators
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Study Chair: Christopher R Chapple, MD Urology Department, Royal Hallamshire Hospital, University of Sheffield, Glossop Road, Sheffield, S10 2JF, UK
Armitage P., Berry G., Matthews JNS Statistical Methods In Medical Research, 4th Ed. Wiley Blackwell Science 2001
de la Rosette J, Alivizatos G, Madersbacher S, Rioja Sanz C, Nordling J, Emberton M, Gravas S, Michel MC, Oelke M. Guidelines on benign prostatic hyperplasia. European Association Urolology 2009
Michel M. The Pharmacological profile of the a1A-Adrenoceptor antagonist silodosin. Eur Urol Suppl. 9 (2010) 486 - 490

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Responsible Party: RECORDATI GROUP
ClinicalTrials.gov Identifier: NCT01757769    
Other Study ID Numbers: KMD 3213 IT-CL 0376
2011-000045-20 ( EudraCT Number )
First Posted: December 31, 2012    Key Record Dates
Last Update Posted: April 29, 2014
Last Verified: April 2014
Keywords provided by RECORDATI GROUP:
Lower urinary tract symptoms
benign prostatic hyperplasia
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents