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

Phase 2

Completed

• Conditions: Nocturia; Prostatic Hyperplasia
• Interventions: Drug: silodosin

• Registration Number: NCT00793819
• Lead Sponsor: Watson Pharmaceuticals

Brief 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

Study Timeline

• Study First Submitted: 2008-11-17
• Study First Submitted QC: 2008-11-18
• Study First Posted: 2008-11-19
• Study Start: 2009-01
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Status Verified: 2012-02
• Results First Submitted: 2012-02-07
• Results First Submitted QC: 2012-02-07
• Last Update Submitted: 2012-02-07
• Results First Posted: 2012-03-09
• Last Update Posted: 2012-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 215

Inclusion Criteria

• Males in good general health and at least 50 years of age, with symptoms of moderate to severe BPH and nocturia (>=2 episodes per night)

Exclusion Criteria

• Medical conditions that would confound the efficacy evaluation.
• Medical conditions in which it would be unsafe to use an alpha-blocker.
• The use of concomitant drugs that would confound the efficacy evaluation.
• The 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
1 Silodosin	silodosin	-
2 Placebo	silodosin	-

Primary Outcome Measures

Name	Time	Method
Change in Nocturia Episodes	12 weeks

Trial Locations

Locations (1)

Watson Investigational Site; 🇺🇸 Burien, Washington, United States