Phase 2
Completed N=151
Use of Silodosin to Treat Moderate to Severe Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome.
Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome
Source: ClinicalTrials.gov NCT00740779 ↗
Enrolled (actual)
151
Serious AEs
1.3%
Results posted
Feb 2012
Primary outcomePrimary: National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Total Score. — 26.0; 26.8; 27.9; -12.1 Units on a 0 to 43 scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Total Score. |
26.0; 26.8; 27.9; -12.1; -10.2; -8.5 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00740779). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.