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A New Drug for Benign Prostatic Hyperplasia (BPH) Compared With Placebo

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: NCT00224120
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : December 3, 2009
Last Update Posted : December 15, 2009
Sponsor:
Information provided by:
Watson Pharmaceuticals

Brief Summary:
A new drug for benign prostatic hyperplasia is compared to placebo for to determine if it is safe and effective. The study lasts approximately 20 weeks.

Condition or disease Intervention/treatment Phase
Benign Prostatic Hyperplasia Drug: Silodosin Other: Placebo Phase 3

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. the following procedures are utilized: physical exams, electrocardiograms, clinical laboratory tests, vital signs, the Internation Prostate Symptom Score, maximum urine flow rate, pharmacokinetics, adverse events, concomitant medications, quality of life, and compliance.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 462 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-Center, Randomized, Double-Blind, Placebo Controlled, Parallel Evaluation of the Efficacy and Safety of a New Drug in the Treatment of the Signs and Symptoms of Benign Prostatic Hyperplasia
Study Start Date : May 2005
Actual Primary Completion Date : May 2006
Actual Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Silodosin

Arm Intervention/treatment
Experimental: Silodosin
Silodosin 8 mg/Day with food
Drug: Silodosin
8 mg daily for 12 weeks
Other Name: Rapaflo

Placebo Comparator: Placebo
Matching placebo capsule once daily with food
Other: Placebo
One capsule daily for 12 weeks




Primary Outcome Measures :
  1. Measuring Change From Baseline in International Prostate Symptom Score (IPSS) at 12 Weeks [ Time Frame: Baseline and 12 weeks ]
    International prostate symptom score: Measuring prostate signs and symptoms asociated with benign prostatic hyperplasia on a 0 to 35 scale; 0 best, 35 worst symptoms


Secondary Outcome Measures :
  1. Change From Baseline in Maximum Urine Flow Rate (Qmax) at 12 Weeks [ Time Frame: Baseline and 12 weeks ]


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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.

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.

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): NCT00224120


Locations
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United States, Alabama
Birmingham, Alabama, United States
United States, California
Carmichael, California, United States
Fresno, California, United States
Laguna Woods, California, United States
San Bernardino, California, United States
Tarzana, California, United States
Torrance, California, United States
United States, Florida
New Port Richey, Florida, United States
Ocala, Florida, United States
Orlando, Florida, United States
Plantation, Florida, United States
Tampa, Florida, United States
West Palm Beach, Florida, United States
United States, Illinois
Chicago, Illinois, United States
Melrose Park, Illinois, United States
United States, Indiana
Evansville, Indiana, United States
Fort Wayne, Indiana, United States
United States, Kansas
Overland Park, Kansas, United States
United States, Maryland
Greenbelt, Maryland, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, Mississippi
Jackson, Mississippi, United States
United States, Missouri
Kansas City, Missouri, United States
United States, New Jersey
Lawrenceville, New Jersey, United States
Voorhees, New Jersey, United States
United States, New Mexico
Albuquerque, New Mexico, United States
United States, New York
Albany, New York, United States
Garden City, New York, United States
Kingston, New York, United States
Poughkeepsie, New York, United States
United States, North Carolina
Concord, North Carolina, United States
United States, Ohio
Cincinnati, Ohio, United States
United States, Oregon
Portland, Oregon, United States
United States, Rhode Island
Providence, Rhode Island, United States
United States, South Carolina
Mt. Pleasant, South Carolina, United States
Myrtle Beach, South Carolina, United States
United States, Texas
Austin, Texas, United States
Dallas, Texas, United States
San Antonio, Texas, United States
United States, Virginia
Norfolk, Virginia, United States
United States, Washington
Seattle, Washington, United States
Tacoma, Washington, United States
United States, Wisconsin
Madison, Wisconsin, United States
Sponsors and Collaborators
Watson Pharmaceuticals
Investigators
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Study Director: Lawrence Hill, PharmD, RPh Watson Pharmaceuticals
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gary Hoel, RPh, PhD, Executive Director of Clinical Research, Watson Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00224120    
Other Study ID Numbers: SI04010
First Posted: September 22, 2005    Key Record Dates
Results First Posted: December 3, 2009
Last Update Posted: December 15, 2009
Last Verified: December 2009
Keywords provided by Watson Pharmaceuticals:
Benign prostatic hyperplasia, alpha blocker
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Hyperplasia
Pathologic Processes
Prostatic Diseases
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