Use of Silodosin to Treat Moderate to Severe Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome.
Completed · Phase 2 · Has a placebo group
Conditions studied: Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome
In brief
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.
Key facts
- Study ID
- NCT00740779
- Run by
- Watson Pharmaceuticals
- People needed
- 153
- Starts
- 2008-09-01
- Expected to finish
- 2009-10-01
- Last updated by the study team
- 2012-02-24
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Watson Investigational Site — San Diego, California, United States
- Watson Investigational Site — Denver, Colorado, United States
- Watson Investigational Site — Columbus, Georgia, United States
- Watson Investigational Site — Roswell, Georgia, United States
- Watson Investigational Site — Jeffersonville, Indiana, United States
- Watson Investigational Site — West Des Moines, Iowa, United States
- Watson Investigational Site — Baltimore, Maryland, United States
- Watson Investigational Site — Boston, Massachusetts, United States
- Watson Investigational Site — Watertown, Massachusetts, United States
- Watson Investigational Site — Omaha, Nebraska, United States
- Watson Investigational Site — Voorhees Township, New Jersey, United States
- Watson Investigational Site — Albuquerque, New Mexico, United States
- Watson Investigational Site — Garden City, New York, United States
- Watson Investigational Site — Kingston, New York, United States
- Watson Investigational Site — New York, New York, United States
- Watson Investigational Site — Poughkeepsie, New York, United States
- Watson Investigational Site — Columbus, Ohio, United States
- Watson Investigational Site — Bethany, Oklahoma, United States
- Watson Investigational Site — Edmond, Oklahoma, United States
- Watson Investigational Site — State College, Pennsylvania, United States
- Watson Investigational Site — Mountlake Terrace, Washington, United States
- Watson Investigational Site — Spokane, Washington, United States
Full record on ClinicalTrials.gov
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