NCT00793819

A Study of Silodosin 8 mg Daily for the Treatment of Nocturia in Men With Benign Prostatic Hyperplasia

A Double-Blind, Placebo-Controlled Phase 2 Study of Silodosin 8 mg Daily for the Treatment of Nocturia in Men With Benign Prostatic Hyperplasia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 215 (actual)
• Sponsor: Watson Pharmaceuticals · Industry
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

Silodosin is compared to placebo to determine if it is safe and effective for the treatment of nighttime urination (nocturia) in men with BPH

Detailed description

This will be a multi-center, double-blind, placebo controlled, parallel, 12 week treatment trial in men with signs and symptoms of benign prostatic hyperplasia and nocturia. The following procedures are utilized; physical exams, electrocardiograms, clinical laboratory tests, vital signs, urinary diary, Pittsburgh Quality of Sleep Index, Nocturia Quality of Life

Conditions

• Nocturia
• Prostatic Hyperplasia

Interventions

Type	Name	Description
DRUG	silodosin	α1-adrenergic antagonist

Timeline

• Start date: 2009-01-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2008-11-19
• Last updated: 2012-03-09
• Results posted: 2012-03-09

Locations

27 sites across 1 country: United States