Evaluation of the Efficacy and Safety of Silodosin in the Treatment of the Signs and Symptoms of BPH

Phase 3

Completed

• Conditions: Benign Prostatic Hyperplasia
• Interventions: Drug: Placebo; Drug: Tamsulosin; Drug: Silodosin

• Registration Number: NCT00359905
• Lead Sponsor: RECORDATI GROUP

Brief Summary

A new drug for the treatment of benign prostatic hyperplasia is compared with placebo and tamsulosin (a drug belonging to the same therapeutic class) for to determine if it is safe and effective (the first phase of the study lasts approximately 18 weeks) and then is used for another 9 months to determine its long-term safety.

Detailed Description

This is a multi-centre, double-blind, placebo and active controlled, parallel 12 week treatment trial in men with signs and symptoms of benign prostatic hyperplasia, followed by a 9 month open-label phase. The following procedures are used: physical exams, electrocardiograms, clinical laboratory tests, vital signs, the International Prostate Symptom Score, maximum urine flow rate, adverse events, concomitant medications, quality of life and compliance. 93 centres in 11 European countries (Finland, France, Germany, Italy, Netherlands, Poland, Romania, Russia, Spain, Ukraine, UK) will be involved

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-08-02
• Study First Submitted QC: 2006-08-02
• Study First Posted: 2006-08-03
• Primary Completion: 2007-05
• Study Completion: 2008-01
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-18
• Last Update Posted: 2009-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 1228

Inclusion Criteria

• Males in good general health and at least 50 years of age, with symptoms of moderate to severe Benign Prostatic Hyperplasia

Exclusion Criteria

• Medical conditions that would confound the efficacy evaluation
• Medical conditions in which it would be unsafe to use an alpha-blocker
• Use of concomitant drugs that would confound the efficacy evaluation
• Use of concomitant drugs that would be unsafe with this alpha-blocker

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Tamsulosin	Tamsulosin	-
Silodosin	Silodosin	-

Primary Outcome Measures

Name	Time	Method
Change in baseline total score on the International Prostate Symptom Score	12 weeks

Secondary Outcome Measures

Name	Time	Method
Change in baseline obstructive subscore of the International Prostate Symptom Score;	12 weeks
change in baseline irritative subscore of the International Prostate Symptom Score;	12 weeks
change in baseline maximum urine flow rate;	12 weeks
safety	52 weeks

Trial Locations

Locations (1)

Sheffield Teaching Hospitals NHS Foundation Trust, Royal Hallamshire Hospital; 🇬🇧 Sheffield, United Kingdom