NCT00740779

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

Completed Phase 2 Results posted Last updated 23 January 2012

What this trial tests

Phase 2 trial testing Silodosin 8 mg in Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome in 153 participants. Completed in 1 October 2009.

Timeline

1 September 2008

Primary endpoint
1 October 2009

1 October 2009

Quick facts

Lead sponsor	Watson Pharmaceuticals
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	153
Start date	1 September 2008
Primary completion	1 October 2009
Estimated completion	1 October 2009
Sites	22 locations across United States

Drugs / interventions tested

• Silodosin 8 mg — full drug profile →
• Placebo
• Silodosin 4 mg — full drug profile →

Conditions studied

• Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome — all drugs for Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome →

Sponsor

Watson Pharmaceuticals — full company profile →

Who can join

18 and older, male only, with Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Pharmacological interventions for treating chronic prostatitis/chronic pelvic pain syndrome.
   Franco JV, Turk T, Jung JH, Xiao YT, et al · · 2019 · cited 54× · PMID 31587256 · DOI 10.1002/14651858.cd012552.pub2
2. New treatments for chronic prostatitis/chronic pelvic pain syndrome.
   Strauss AC, Dimitrakov JD. · · 2010 · cited 43× · PMID 20142810 · DOI 10.1038/nrurol.2010.4