Abacterial Chronic Prostatitis/Chronic Pelvic Pain Syndrome Clinical Trial
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
| Verified date | January 2012 |
| Source | Watson Pharmaceuticals |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 153 |
| Est. completion date | October 2009 |
| Est. primary completion date | October 2009 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 18 Years and older |
| Eligibility |
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 a-blocked therapy for chronic prostatitis/chronic pelvic pain syndrome or is currently receiving a-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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Watson Investigational Site | Albuquerque | New Mexico |
| United States | Watson Investigational Site | Baltimore | Maryland |
| United States | Watson Investigational Site | Bethany | Oklahoma |
| United States | Watson Investigational Site | Boston | Massachusetts |
| United States | Watson Investigational Site | Columbus | Georgia |
| United States | Watson Investigational Site | Columbus | Ohio |
| United States | Watson Investigational Site | Denver | Colorado |
| United States | Watson Investigational Site | Edmond | Oklahoma |
| United States | Watson Investigational Site | Garden City | New York |
| United States | Watson Investigational Site | Jeffersonville | Indiana |
| United States | Watson Investigational Site | Kingston | New York |
| United States | Watson Investigational Site | Mountlake Terrace | Washington |
| United States | Watson Investigational Site | New York | New York |
| United States | Watson Investigational Site | Omaha | Nebraska |
| United States | Watson Investigational Site | Poughkeepsie | New York |
| United States | Watson Investigational Site | Roswell | Georgia |
| United States | Watson Investigational Site | San Diego | California |
| United States | Watson Investigational Site | Spokane | Washington |
| United States | Watson Investigational Site | State College | Pennsylvania |
| United States | Watson Investigational Site | Voorhees | New Jersey |
| United States | Watson Investigational Site | Watertown | Massachusetts |
| United States | Watson Investigational Site | West Des Moines | Iowa |
| Lead Sponsor | Collaborator |
|---|---|
| Watson Pharmaceuticals |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Total Score. | Change from baseline In NIH-CPSI at Week 12. Three separate domain scores are calculated as pain, urinary symptoms, and quality of life impact. NIH-CPSI total score uses a 0 to 43 scale; 0 best, 43 worse symptoms. | 12 weeks | No |