Use of Silodosin to Treat Moderate to Severe Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome.
CompletedPhase 2NCT00740779
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- 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
- Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome
- Interventions
- Drug: Silodosin 8 mg
- Drug: Placebo
- Drug: Silodosin 4 mg
- Sponsor
- Watson Pharmaceuticals
- Start date
- 2008-09
- Primary completion
- 2009-10
- Sex
- Male
- Age range
- from 18 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 22
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00740779