Use of Silodosin to Treat Moderate to Severe Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome.
NCT ID: NCT00740779
Last Updated: 2012-02-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
153 participants
INTERVENTIONAL
2008-09-30
2009-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Silodosin 4 mg
4 mg daily
Silodosin 4 mg
Silodosin 4 mg daily
Silodosin 8 mg
Silodosin 8 mg daily
Silodosin 8 mg
Silodosin 8 mg daily
Placebo
1 placebo capsule daily
Placebo
Placebo
Interventions
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Silodosin 8 mg
Silodosin 8 mg daily
Placebo
Placebo
Silodosin 4 mg
Silodosin 4 mg daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has a total NIH-CPSI total score of 15
* Has a NIH-CPSI pain score of 8
* Has had pain in the pelvic region for at least 3 months prior to screening
Exclusion Criteria
* Has previously received α-blocked therapy for chronic prostatitis/chronic pelvic pain syndrome or is currently receiving α-blocked therapy for any condition
* Has experience ≥2 urinary tract infections within the previous 12 months
* Has any medical condition that in the opinion of the investigator precludes safe participation in the study
* Has any medical condition that could confound the efficacy evaluation
* Is receiving ketoconazole, or other known potent inhibitors of cytochrome P450 3A4 or any medication in the opinion of the investigator that precludes safe participation in the study
* Is receiving any medication that in the opinion of the investigator that could confound the efficacy evaluation
* Has participated in a study involving the administration of an investigational agent within the past 30 days
18 Years
MALE
No
Sponsors
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Watson Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Kim Caramelli, MS
Role: STUDY_DIRECTOR
Watson Pharmaceuticals
Locations
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Watson Investigational Site
San Diego, California, United States
Watson Investigational Site
Denver, Colorado, United States
Watson Investigational Site
Columbus, Georgia, United States
Watson Investigational Site
Roswell, Georgia, United States
Watson Investigational Site
Jeffersonville, Indiana, United States
Watson Investigational Site
West Des Moines, Iowa, United States
Watson Investigational Site
Baltimore, Maryland, United States
Watson Investigational Site
Boston, Massachusetts, United States
Watson Investigational Site
Watertown, Massachusetts, United States
Watson Investigational Site
Omaha, Nebraska, United States
Watson Investigational Site
Voorhees Township, New Jersey, United States
Watson Investigational Site
Albuquerque, New Mexico, United States
Watson Investigational Site
Garden City, New York, United States
Watson Investigational Site
Kingston, New York, United States
Watson Investigational Site
New York, New York, United States
Watson Investigational Site
Poughkeepsie, New York, United States
Watson Investigational Site
Columbus, Ohio, United States
Watson Investigational Site
Bethany, Oklahoma, United States
Watson Investigational Site
Edmond, Oklahoma, United States
Watson Investigational Site
State College, Pennsylvania, United States
Watson Investigational Site
Mountlake Terrace, Washington, United States
Watson Investigational Site
Spokane, Washington, United States
Countries
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References
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Nickel JC, O'Leary MP, Lepor H, Caramelli KE, Thomas H, Hill LA, Hoel GE. Silodosin for men with chronic prostatitis/chronic pelvic pain syndrome: results of a phase II multicenter, double-blind, placebo controlled study. J Urol. 2011 Jul;186(1):125-31. doi: 10.1016/j.juro.2011.03.028. Epub 2011 May 14.
Other Identifiers
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SI08001
Identifier Type: -
Identifier Source: org_study_id
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