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NCT00793819 Clinical Trial

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

Prostatic Hyperplasia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00793819
Other study ID # SI08005
Secondary ID
Status Completed
Phase Phase 2
First received November 17, 2008
Last updated February 7, 2012
Start date January 2009
Est. completion date October 2009

Study information
Verified date February 2012
Source Watson Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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

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

Recruitment information / eligibility
Status Completed
Enrollment 215
Est. completion date October 2009
Est. primary completion date October 2009
Accepts healthy volunteers No
Gender Male
Age group 50 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• silodosin
a1-adrenergic antagonist

Locations
Country Name City State
United States Watson Investigational Site Albuquerque New Mexico
United States Watson Investigational Site Aventura Florida
United States Watson Investigational Site Bala Cynwyd Pennsylvania
United States Watson Investigational Site Bay Shore New York
United States Watson Investigational Site Bethany Oklahoma
United States Watson Investigational Site Burien Washington
United States Watson Investigational Site Clearwater Florida
United States Watson Investigational Site Coeur d'Alene Idaho
United States Watson Investigational Site Concord North Carolina
United States Watson Investigational Site Greenbelt Maryland
United States Watson Investigational Site Huntsville Alabama
United States Watson Investigational Site Laguna Hills California
United States Watson Investigational Site Las Vegas Nevada
United States Watson Investigational Site Lawrenceville New Jersey
United States Watson Investigational Site Marietta Georgia
United States Watson Investigational Site Missoula Montana
United States Watson Investigational Site Myrtle Beach South Carolina
United States Watson Investigational Site New York New York
United States Watson Investigational Site Omaha Nebraska
United States Watson Investigational Site Orlando Florida
United States Watson Investigational Site Paducah Kentucky
United States Watson Investigational Site Salisbury North Carolina
United States Watson Investigational Site San Diego California
United States Watson Investigational Site Sandy Springs Georgia
United States Watson Investigational Site Troy Michigan
United States Watson Investigational Site West Des Moines Iowa
United States Watson Investigational Site Williamsville New York

Sponsors (1)
Lead Sponsor Collaborator
Watson Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Nocturia Episodes 12 weeks No
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