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

February 7, 2012 updated by: Watson Pharmaceuticals

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

215

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1 Silodosin
Drug: silodosin
α1-adrenergic antagonist
Other Names:
  • Rapaflo
Placebo Comparator: 2 Placebo
Drug: silodosin
α1-adrenergic antagonist
Other Names:
  • Rapaflo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Nocturia Episodes
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Watson Pharmaceuticals

Investigators

  • Study Director: Kim Caramelli, MS, Watson Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

November 17, 2008

First Submitted That Met QC Criteria

November 18, 2008

First Posted (Estimate)

November 19, 2008

Study Record Updates

Last Update Posted (Estimate)

March 9, 2012

Last Update Submitted That Met QC Criteria

February 7, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SI08005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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