Clinical Trial: Use of Silodosin to Treat Moderate to Severe Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome.

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Pel

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 Summary: 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.
Sponsor: Watson Pharmaceuticals

Current Primary Outcome: National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Total Score. [ Time Frame: 12 weeks ]

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.


Original Primary Outcome: NIH-CPSI total score. [ Time Frame: 12 weeks ]

Current Secondary Outcome:

Original Secondary Outcome:

  • NIH-CPSI pain score [ Time Frame: 12 weeks ]
  • NIH-CPSI urinary symptoms score [ Time Frame: 12 weeks ]
  • SF-12 [ Time Frame: 12 weeks ]


Information By: Watson Pharmaceuticals

Dates:
Date Received: August 21, 2008
Date Started: September 2008
Date Completion:
Last Updated: January 23, 2012
Last Verified: January 2012