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

Phase 2

Completed

• Conditions: Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome
• Interventions: Drug: Silodosin 4 mg; Drug: Silodosin 8 mg; Drug: Placebo

• Registration Number: NCT00740779
• Lead Sponsor: Watson Pharmaceuticals

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.

Study Timeline

• Study First Submitted: 2008-08-21
• Study First Submitted QC: 2008-08-22
• Study First Posted: 2008-08-25
• Study Start: 2008-09
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Status Verified: 2012-01
• Results First Submitted: 2012-01-23
• Results First Submitted QC: 2012-01-23
• Last Update Submitted: 2012-01-23
• Results First Posted: 2012-02-24
• Last Update Posted: 2012-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 153

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Silodosin 4 mg	Silodosin 4 mg	4 mg daily
Silodosin 8 mg	Silodosin 8 mg	Silodosin 8 mg daily
Placebo	Placebo	1 placebo capsule daily

Primary Outcome Measures

Name	Time	Method
National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Total Score.	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.

Trial Locations

Locations (1)

Watson Investigational Site; 🇺🇸 Spokane, Washington, United States