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

Primary Purpose

Nocturia, Prostatic Hyperplasia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
silodosin
Sponsored by
Watson Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nocturia focused on measuring nocturia, BPH, benign prostate hyperplasia, nocturia in men with benign prostate hyperplasia

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Watson Investigational Site
  • Watson Investigational Site
  • Watson Investigational Site
  • Watson Investigational Site
  • Watson Investigational Site
  • Watson Investigational Site
  • Watson Investigational Site
  • Watson Investigational Site
  • Watson Investigational Site
  • Watson Investigational Site
  • Watson Investigational Site
  • Watson Investigational Site
  • Watson Investigational Site
  • Watson Investigational Site
  • Watson Investigational Site
  • Watson Investigational Site
  • Watson Investigational Site
  • Watson Investigational Site
  • Watson Investigational Site
  • Watson Investigational Site
  • Watson Investigational Site
  • Watson Investigational Site
  • Watson Investigational Site
  • Watson Investigational Site
  • Watson Investigational Site
  • Watson Investigational Site
  • Watson Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1 Silodosin

2 Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change in Nocturia Episodes

Secondary Outcome Measures

Full Information

First Posted
November 17, 2008
Last Updated
February 7, 2012
Sponsor
Watson Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00793819
Brief Title
A Study of Silodosin 8 mg Daily for the Treatment of Nocturia in Men With Benign Prostatic Hyperplasia
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Watson Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nocturia, Prostatic Hyperplasia
Keywords
nocturia, BPH, benign prostate hyperplasia, nocturia in men with benign prostate hyperplasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
215 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 Silodosin
Arm Type
Experimental
Arm Title
2 Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
silodosin
Other Intervention Name(s)
Rapaflo
Intervention Description
α1-adrenergic antagonist
Primary Outcome Measure Information:
Title
Change in Nocturia Episodes
Time Frame
12 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim Caramelli, MS
Organizational Affiliation
Watson Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Watson Investigational Site
City
Huntsville
State/Province
Alabama
Country
United States
Facility Name
Watson Investigational Site
City
Laguna Hills
State/Province
California
Country
United States
Facility Name
Watson Investigational Site
City
San Diego
State/Province
California
Country
United States
Facility Name
Watson Investigational Site
City
Aventura
State/Province
Florida
Country
United States
Facility Name
Watson Investigational Site
City
Clearwater
State/Province
Florida
Country
United States
Facility Name
Watson Investigational Site
City
Orlando
State/Province
Florida
Country
United States
Facility Name
Watson Investigational Site
City
Marietta
State/Province
Georgia
Country
United States
Facility Name
Watson Investigational Site
City
Sandy Springs
State/Province
Georgia
Country
United States
Facility Name
Watson Investigational Site
City
Coeur d'Alene
State/Province
Idaho
Country
United States
Facility Name
Watson Investigational Site
City
West Des Moines
State/Province
Iowa
Country
United States
Facility Name
Watson Investigational Site
City
Paducah
State/Province
Kentucky
Country
United States
Facility Name
Watson Investigational Site
City
Greenbelt
State/Province
Maryland
Country
United States
Facility Name
Watson Investigational Site
City
Troy
State/Province
Michigan
Country
United States
Facility Name
Watson Investigational Site
City
Missoula
State/Province
Montana
Country
United States
Facility Name
Watson Investigational Site
City
Omaha
State/Province
Nebraska
Country
United States
Facility Name
Watson Investigational Site
City
Las Vegas
State/Province
Nevada
Country
United States
Facility Name
Watson Investigational Site
City
Lawrenceville
State/Province
New Jersey
Country
United States
Facility Name
Watson Investigational Site
City
Albuquerque
State/Province
New Mexico
Country
United States
Facility Name
Watson Investigational Site
City
Bay Shore
State/Province
New York
Country
United States
Facility Name
Watson Investigational Site
City
New York
State/Province
New York
Country
United States
Facility Name
Watson Investigational Site
City
Williamsville
State/Province
New York
Country
United States
Facility Name
Watson Investigational Site
City
Concord
State/Province
North Carolina
Country
United States
Facility Name
Watson Investigational Site
City
Salisbury
State/Province
North Carolina
Country
United States
Facility Name
Watson Investigational Site
City
Bethany
State/Province
Oklahoma
Country
United States
Facility Name
Watson Investigational Site
City
Bala Cynwyd
State/Province
Pennsylvania
Country
United States
Facility Name
Watson Investigational Site
City
Myrtle Beach
State/Province
South Carolina
Country
United States
Facility Name
Watson Investigational Site
City
Burien
State/Province
Washington
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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