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

Watson Pharmaceuticals215 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

215

Conditions

Nocturia Prostatic Hyperplasia

Interventions

silodosinDRUG

α1-adrenergic antagonist

Eligibility

Sex: MALEMin age: 50 Years

Medical Language ↔ Plain English

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.

Locations (27)

Outcomes

Primary Outcomes

Change in Nocturia Episodes

Time frame: 12 weeks

Data from ClinicalTrials.gov

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