Clinical Trial: Effectiveness and Safety of Silodosin in the Treatment of Benign Prostatic Hyperplasia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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-lif

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.

Detailed Summary:

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.

Sponsor: Recordati Industria Chimica e Farmaceutica S.p.A.

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

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

Original Secondary Outcome: Same as current

Information By: Recordati Industria Chimica e Farmaceutica S.p.A.

Dates:
Date Received: December 21, 2012
Date Started: May 2011
Date Completion:
Last Updated: April 28, 2014
Last Verified: April 2014