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

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Watson Pharmaceuticals
• Treatments: Silodosin

Criteria

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