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Silodosin is compared to placebo to determine if it is safe and effective for the treatment of nighttime urination (nocturia) in men with BPH
This will be a multi-center, double-blind, placebo controlled, parallel, 12 week treatment trial in men with signs and symptoms of benign prostatic hyperplasia and nocturia. The following procedures are utilized; physical exams, electrocardiograms, clinical laboratory tests, vital signs, urinary diary, Pittsburgh Quality of Sleep Index, Nocturia Quality of Life
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 Silodosin | Experimental |
| |
| 2 Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| silodosin | Drug | α1-adrenergic antagonist |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Nocturia Episodes | 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 | Huntsville | Alabama | United States | |||
| Watson Investigational Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Silodosin 8mg | Silodosin 8mg daily |
| FG001 | Placebo | 1 placebo capsule daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Laguna Hills |
| California |
| United States |
| Watson Investigational Site | San Diego | California | United States |
| Watson Investigational Site | Aventura | Florida | United States |
| Watson Investigational Site | Clearwater | Florida | United States |
| Watson Investigational Site | Orlando | Florida | United States |
| Watson Investigational Site | Marietta | Georgia | United States |
| Watson Investigational Site | Sandy Springs | Georgia | United States |
| Watson Investigational Site | Coeur d'Alene | Idaho | United States |
| Watson Investigational Site | West Des Moines | Iowa | United States |
| Watson Investigational Site | Paducah | Kentucky | United States |
| Watson Investigational Site | Greenbelt | Maryland | United States |
| Watson Investigational Site | Troy | Michigan | United States |
| Watson Investigational Site | Missoula | Montana | United States |
| Watson Investigational Site | Omaha | Nebraska | United States |
| Watson Investigational Site | Las Vegas | Nevada | United States |
| Watson Investigational Site | Lawrenceville | New Jersey | United States |
| Watson Investigational Site | Albuquerque | New Mexico | United States |
| Watson Investigational Site | Bay Shore | New York | United States |
| Watson Investigational Site | New York | New York | United States |
| Watson Investigational Site | Williamsville | New York | United States |
| Watson Investigational Site | Concord | North Carolina | United States |
| Watson Investigational Site | Salisbury | North Carolina | United States |
| Watson Investigational Site | Bethany | Oklahoma | United States |
| Watson Investigational Site | Bala-Cynwyd | Pennsylvania | United States |
| Watson Investigational Site | Myrtle Beach | South Carolina | United States |
| Watson Investigational Site | Burien | Washington | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Silodosin 8mg | Silodosin 8mg daily |
| BG001 | Placebo | 1 placebo capsule daily |
| BG002 | 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 | Change in Nocturia Episodes | The number of participants for analysis is determined by Last Observation Carried Forward (LOCF). | Posted | Mean | Standard Deviation | episodes | 12 weeks |
|
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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 8mg | Silodosin 8mg daily | 1 | 111 | 39 | 111 | ||
| EG001 | Placebo | 1 placebo capsule daily | 1 | 98 | 21 | 98 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Multiple Bone Fracture | Musculoskeletal and connective tissue 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 |
| |
| Headache | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Urinary Track Infection | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Upper Respiratory Track Infection | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal 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 |
|---|---|
| D053158 | Nocturia |
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 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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| >=65 years |
|
| Male |
|