Status:
COMPLETED
Use of Silodosin to Treat Moderate to Severe Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome.
Lead Sponsor:
Watson Pharmaceuticals
Conditions:
Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome
Eligibility:
MALE
18+ years
Phase:
PHASE2
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...
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
- 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
- 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
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT00740779
Start Date
September 1 2008
End Date
October 1 2009
Last Update
February 24 2012
Active Locations (22)
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1
Watson Investigational Site
San Diego, California, United States
2
Watson Investigational Site
Denver, Colorado, United States
3
Watson Investigational Site
Columbus, Georgia, United States
4
Watson Investigational Site
Roswell, Georgia, United States