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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome

Intervention / Treatment
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* Drug: Silodosin 8 mg
* Drug: Placebo
* Drug: Silodosin 4 mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Silodosin 4 mg<br>4 mg daily | Drug: Silodosin 4 mg<br>* Silodosin 4 mg daily<br>* Other names: Rapaflo;|
| Experimental: Silodosin 8 mg<br>Silodosin 8 mg daily | Drug: Silodosin 8 mg<br>* Silodosin 8 mg daily<br>* Other names: Rapaflo;|
| Placebo Comparator: Placebo<br>1 placebo capsule daily | Drug: Placebo<br>* Placebo<br>* Other names: Placebo control.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Total Score. | 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. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostatitis, chronic pelvic pain