Clinical trial NCT00740779: Use of Silodosin to Treat Moderate to Severe Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome.
Official title: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome
Keywords: prostatitis, chronic pelvic pain
Lead sponsor: Watson Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-08-25
Enrollment: 153
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Male, at least 18 years of age
* 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 participated in a Watson study with silodosin
* 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

Primary outcomes:
measure: National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Total Score.
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Watson Investigational Site
state: California
city: Denver
country: United States
facility: Watson Investigational Site
state: Colorado
city: Columbus
country: United States
facility: Watson Investigational Site
state: Georgia
city: Roswell
country: United States
facility: Watson Investigational Site
state: Georgia
city: Jeffersonville
country: United States
facility: Watson Investigational Site
state: Indiana
city: West Des Moines
country: United States
facility: Watson Investigational Site
state: Iowa
city: Baltimore
country: United States
facility: Watson Investigational Site
state: Maryland
city: Boston
country: United States
facility: Watson Investigational Site
state: Massachusetts
city: Watertown
country: United States
facility: Watson Investigational Site
state: Massachusetts
city: Omaha
country: United States
facility: Watson Investigational Site
state: Nebraska
city: Voorhees
country: United States
facility: Watson Investigational Site
state: New Jersey
city: Albuquerque
country: United States
facility: Watson Investigational Site
state: New Mexico
city: Garden City
country: United States
facility: Watson Investigational Site
state: New York
city: Kingston
country: United States
facility: Watson Investigational Site
state: New York
city: New York
country: United States
facility: Watson Investigational Site
state: New York
city: Poughkeepsie
country: United States
facility: Watson Investigational Site
state: New York
city: Columbus
country: United States
facility: Watson Investigational Site
state: Ohio
city: Bethany
country: United States
facility: Watson Investigational Site
state: Oklahoma
city: Edmond
country: United States
facility: Watson Investigational Site
state: Oklahoma
city: State College
country: United States
facility: Watson Investigational Site
state: Pennsylvania
city: Mountlake Terrace
country: United States
facility: Watson Investigational Site
state: Washington
city: Spokane
country: United States
facility: Watson Investigational Site
state: Washington
Study officials:
affiliation: Watson Pharmaceuticals
name: Kim Caramelli, MS
role: STUDY_DIRECTOR
References:
citation: 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.