The primary objective is to compare the efficacy of silodosin 4 and 8 mg once daily with placebo in the treatment of subjects with moderate to severe abacterial chronic prostatitis/chronic pelvic pain syndrome during a 12 week treatment period. The secondary objective is to compare the safety of silodosin 4 and 8 mg once daily with placebo.
A Multi-Center, Double-Blind, Placebo-Controlled Investigation of Silodosin in the Treatment of Subjects With Moderate to Severe Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
153
Watson Investigational Site
San Diego, California, United States
National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Total Score.
Change from baseline In NIH-CPSI at Week 12. Three separate domain scores are calculated as pain, urinary symptoms, and quality of life impact. NIH-CPSI total score uses a 0 to 43 scale; 0 best, 43 worse symptoms.
Time frame: 12 weeks
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Watson Investigational Site
Denver, Colorado, United States
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Columbus, Georgia, United States
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Roswell, Georgia, United States
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Jeffersonville, Indiana, United States
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West Des Moines, Iowa, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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Watertown, Massachusetts, United States
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Omaha, Nebraska, United States
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