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

April 28, 2014 updated by: RECORDATI GROUP

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1036

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20132
        • Vita e Salute University, Department of Urology, Istituto Scientifico Ospedale San Raffaele

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

56 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Silodosin
Silodosin capsule 8 mg daily for 24 weeks
Drug: Silodosin
8 mg daily for 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 months o treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in IPSS total score
Time Frame: 4, 12, 24 weeks of treatment
4, 12, 24 weeks of treatment

Other Outcome Measures

Outcome Measure
Time Frame
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
6 months of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RECORDATI GROUP

Investigators

  • Study Chair: Christopher R Chapple, MD, Urology Department, Royal Hallamshire Hospital, University of Sheffield, Glossop Road, Sheffield, S10 2JF, UK

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

December 21, 2012

First Submitted That Met QC Criteria

December 28, 2012

First Posted (Estimate)

December 31, 2012

Study Record Updates

Last Update Posted (Estimate)

April 29, 2014

Last Update Submitted That Met QC Criteria

April 28, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KMD 3213 IT-CL 0376
  • 2011-000045-20 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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