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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Silodosin 4 mg | Experimental | 4 mg daily |
|
| Silodosin 8 mg | Experimental | Silodosin 8 mg daily |
|
| Placebo | Placebo Comparator | 1 placebo capsule daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Silodosin 8 mg | Drug | Silodosin 8 mg daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kim Caramelli, MS | Watson Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Watson Investigational Site | San Diego | California | United States | |||
| Watson Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21571345 | Derived | Nickel JC, O'Leary MP, Lepor H, Caramelli KE, Thomas H, Hill LA, Hoel GE. Silodosin for men with chronic prostatitis/chronic pelvic pain syndrome: results of a phase II multicenter, double-blind, placebo controlled study. J Urol. 2011 Jul;186(1):125-31. doi: 10.1016/j.juro.2011.03.028. Epub 2011 May 14. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Silodosin 4 mg | Silodosin 4 mg daily |
| FG001 | Silodosin 8 mg | Silodosin 8 mg daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | Placebo |
|
|
| Silodosin 4 mg | Drug | Silodosin 4 mg daily |
|
|
| 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 |
| FG002 |
| Placebo |
1 placebo capsule daily |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Silodosin 4 mg | Silodosin 4 mg daily |
| BG001 | Silodosin 8 mg | Silodosin 8 mg daily |
| BG002 | Placebo | 1 placebo capsule daily |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The number of participants for analysis is determined by Last Observation Carried Forward (LOCF). | Posted | Nov 2010 | Mean | Standard Deviation | Units on a 0 to 43 scale | 12 weeks |
|
|
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Silodosin 4 mg | Silodosin 4 mg daily | 2 | 52 | 22 | 52 | ||
| EG001 | Silodosin 8 mg | Silodosin 8 mg daily | 0 | 45 | 25 | 45 | ||
| EG002 | Placebo | 1 placebo capsule daily | 0 | 54 | 12 | 54 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urosepsis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Retrograde Ejaculation | Reproductive system and breast disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Libido Decreased | Reproductive system and breast disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Neurogenic Bladder | Renal and urinary disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gary Hoel, RPh, PhD, Vice President, Global Brand Clinical Research | Watson Pharmaceuticals | 801-588-6641 | gary.hoel@watson.com |
| ID | Term |
|---|---|
| D011472 | Prostatitis |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C095285 | silodosin |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
|