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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Recordati Industria Chimica e Farmaceutica S.p.A.
ClinicalTrials.gov Identifier:
NCT01757769
First received: December 21, 2012
Last updated: December 28, 2012
Last verified: December 2012
  Purpose

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 Intervention Phase
Benign Prostatic Hyperplasia
Drug: Silodosin
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Recordati Industria Chimica e Farmaceutica S.p.A.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in IPSS total score [ Time Frame: 4, 12, 24 weeks of treatment ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 1036
Study Start Date: May 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Silodosin
Silodosin capsule 8 mg daily for 24 weeks
Drug: Silodosin
8 mg daily for 24 weeks

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.
  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01757769

Locations
Italy
Vita e Salute University, Department of Urology, Istituto Scientifico Ospedale San Raffaele
Milan, Italy, 20132
Sponsors and Collaborators
Recordati Industria Chimica e Farmaceutica S.p.A.
Investigators
Study Chair: Christopher R Chapple, MD Urology Department, Royal Hallamshire Hospital, University of Sheffield, Glossop Road, Sheffield, S10 2JF, UK
  More Information

Publications:

Responsible Party: Recordati Industria Chimica e Farmaceutica S.p.A.
ClinicalTrials.gov Identifier: NCT01757769     History of Changes
Other Study ID Numbers: KMD 3213 IT-CL 0376, 2011-000045-20
Study First Received: December 21, 2012
Last Updated: December 28, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Ireland: Irish Medicines Board
Italy: The Italian Medicines Agency
Portugal: National Pharmacy and Medicines Institute
Romania: National Agency for Medicines and Medical Devices
Spain: Spanish Agency of Medicines
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Recordati Industria Chimica e Farmaceutica S.p.A.:
Lower urinary tract symptoms
benign prostatic hyperplasia

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014