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

Watson Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome

Treatments: Drug: Silodosin 4 mg; Drug: Placebo; Drug: Silodosin 8 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00740779

SI08001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 153 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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153 participants in 3 patient groups, including a placebo group

Silodosin 4 mg

Experimental group

Description:

4 mg daily

Treatment:

Drug: Silodosin 4 mg

Silodosin 8 mg

Experimental group

Description:

Silodosin 8 mg daily

Treatment:

Drug: Silodosin 8 mg

Placebo

Placebo Comparator group

Description:

1 placebo capsule daily

Treatment:

Drug: Placebo