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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: NCT00224107
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : December 3, 2009
Last Update Posted : July 12, 2011
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 (BPH) 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 International 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 : 461 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 : August 2006
Actual Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Silodosin

Arm Intervention/treatment
Experimental: Silodosin
Silodosin 8 mg once daily 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
1 capsule daily for 12 weeks




Primary Outcome Measures :
  1. International Prostate Symptom Score (IPSS) [ Time Frame: 12 weeks ]
    Change from baseline In IPSS at Week 12. IPSS uses a 0 to 35 scale; 0 best, 35 worse symptoms


Secondary Outcome Measures :
  1. Maximum Urine Flow Rate (Qmax) [ Time Frame: 12 weeks ]
    Change from baseline in maximum urine flow rate (Qmax)at Week 12



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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 benign prostatic hyperplasia.

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): NCT00224107


Locations
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United States, Alabama
Huntsville, Alabama, United States
United States, Arizona
Tucson, Arizona, United States
United States, California
Anaheim, California, United States
Culver City, California, United States
Irvine, California, United States
La Jolla, California, United States
Long Beach, California, United States
Newport Beach, California, United States
San Diego, California, United States
United States, Colorado
Aurora, Colorado, United States
Wheat Ridge, Colorado, United States
United States, Connecticut
Waterbury, Connecticut, United States
United States, Florida
Aventura, Florida, United States
Clearwater, Florida, United States
Coral Gables, Florida, United States
Pensacola, Florida, United States
United States, Georgia
Marietta, Georgia, United States
United States, Illinois
Chicago, Illinois, United States
Peoria, Illinois, United States
United States, Iowa
Des Moines, Iowa, United States
United States, Michigan
St. Joseph, Michigan, United States
United States, Minnesota
Edina, Minnesota, United States
United States, Montana
Missoula, Montana, United States
United States, Nevada
Las Vegas, Nevada, United States
United States, New York
Bay Shore, New York, United States
Garden City, New York, United States
Manhasset, New York, United States
New York, New York, United States
Staten Island, New York, United States
Williamsville, New York, United States
United States, North Carolina
Charlotte, North Carolina, United States
Salisbury, North Carolina, United States
Winston-Salem, North Carolina, United States
United States, Ohio
Cincinnati, Ohio, United States
United States, Oklahoma
Bethany, Oklahoma, United States
United States, Oregon
Portland, Oregon, United States
United States, Pennsylvania
Lancaster, Pennsylvania, United States
United States, South Carolina
Greer, South Carolina, United States
United States, Texas
Dallas, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
United States, Washington
Lakewood, Washington, United States
Tacoma, Washington, United States
United States, Wisconsin
Milwaukee, Wisconsin, United States
Sponsors and Collaborators
Watson Pharmaceuticals
Investigators
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Study Director: Lawrence Hill, PharmD, RPh Watson Pharmaceuticals
Publications of Results:
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: NCT00224107    
Other Study ID Numbers: SI04009
First Posted: September 22, 2005    Key Record Dates
Results First Posted: December 3, 2009
Last Update Posted: July 12, 2011
Last Verified: July 2011
Keywords provided by Watson Pharmaceuticals:
Benign prostatic hyperplasia, BPH, 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