Use of Silodosin to Treat Moderate to Severe Abacterial Chronic Prostatitis/Chronic Pelvic Pain S… (NCT00740779) | Clinical Trial Compass
CompletedPhase 2
Use of Silodosin to Treat Moderate to Severe Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome.
United States153 participantsStarted 2008-09
Plain-language 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.
Who can participate
Age range18 Years
SexMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Total Score.