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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00793819
Recruitment Status : Completed
First Posted : November 19, 2008
Results First Posted : March 9, 2012
Last Update Posted : March 9, 2012
Sponsor:
Information provided by (Responsible Party):
Watson Pharmaceuticals

Study Description
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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

Condition or disease Intervention/treatment Phase
Nocturia Prostatic Hyperplasia Drug: silodosin Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 215 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : January 2009
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Silodosin

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 Silodosin Drug: silodosin
α1-adrenergic antagonist
Other Name: Rapaflo
Placebo Comparator: 2 Placebo Drug: silodosin
α1-adrenergic antagonist
Other Name: Rapaflo


Outcome Measures
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Primary Outcome Measures :
  1. Change in Nocturia Episodes [ Time Frame: 12 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00793819


Locations
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United States, Alabama
Watson Investigational Site
Huntsville, Alabama, United States
United States, California
Watson Investigational Site
Laguna Hills, California, United States
Watson Investigational Site
San Diego, California, United States
United States, Florida
Watson Investigational Site
Aventura, Florida, United States
Watson Investigational Site
Clearwater, Florida, United States
Watson Investigational Site
Orlando, Florida, United States
United States, Georgia
Watson Investigational Site
Marietta, Georgia, United States
Watson Investigational Site
Sandy Springs, Georgia, United States
United States, Idaho
Watson Investigational Site
Coeur d'Alene, Idaho, United States
United States, Iowa
Watson Investigational Site
West Des Moines, Iowa, United States
United States, Kentucky
Watson Investigational Site
Paducah, Kentucky, United States
United States, Maryland
Watson Investigational Site
Greenbelt, Maryland, United States
United States, Michigan
Watson Investigational Site
Troy, Michigan, United States
United States, Montana
Watson Investigational Site
Missoula, Montana, United States
United States, Nebraska
Watson Investigational Site
Omaha, Nebraska, United States
United States, Nevada
Watson Investigational Site
Las Vegas, Nevada, United States
United States, New Jersey
Watson Investigational Site
Lawrenceville, New Jersey, United States
United States, New Mexico
Watson Investigational Site
Albuquerque, New Mexico, United States
United States, New York
Watson Investigational Site
Bay Shore, New York, United States
Watson Investigational Site
New York, New York, United States
Watson Investigational Site
Williamsville, New York, United States
United States, North Carolina
Watson Investigational Site
Concord, North Carolina, United States
Watson Investigational Site
Salisbury, North Carolina, United States
United States, Oklahoma
Watson Investigational Site
Bethany, Oklahoma, United States
United States, Pennsylvania
Watson Investigational Site
Bala Cynwyd, Pennsylvania, United States
United States, South Carolina
Watson Investigational Site
Myrtle Beach, South Carolina, United States
United States, Washington
Watson Investigational Site
Burien, Washington, United States
Sponsors and Collaborators
Watson Pharmaceuticals
Investigators
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Study Director: Kim Caramelli, MS Watson Pharmaceuticals
More Information
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Responsible Party: Watson Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00793819    
Other Study ID Numbers: SI08005
First Posted: November 19, 2008    Key Record Dates
Results First Posted: March 9, 2012
Last Update Posted: March 9, 2012
Last Verified: February 2012
Keywords provided by Watson Pharmaceuticals:
nocturia
BPH
benign prostate hyperplasia
nocturia in men with benign prostate hyperplasia
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Hyperplasia
Nocturia
Pathologic Processes
Prostatic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Silodosin
 Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents