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A new drug for benign prostatic hyperplasia is compared to placebo for to determine if it is safe and effective. The study lasts approximately 20 weeks.
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. The following procedures are utilized: physical exams, electrocardiograms, clinical laboratory tests, vital signs, the International Prostate Symptom Score, maximum urine flow rate, pharmacokinetics, adverse events, concomitant medications, quality of life, and compliance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Silodosin | Experimental | Silodosin 8 mg once daily with food |
|
| placebo | Placebo Comparator | Matching Placebo capsule once daily with food |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Silodosin | Drug | 8 mg daily for 12 weeks |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| International Prostate Symptom Score (IPSS) | Change from baseline In IPSS at Week 12. IPSS uses a 0 to 35 scale; 0 best, 35 worse symptoms | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Urine Flow Rate (Qmax) | Change from baseline in maximum urine flow rate (Qmax)at Week 12 | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lawrence Hill, PharmD, RPh | Watson Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntsville | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19371887 | Result | Marks LS, Gittelman MC, Hill LA, Volinn W, Hoel G. Rapid efficacy of the highly selective alpha1A-adrenoceptor antagonist silodosin in men with signs and symptoms of benign prostatic hyperplasia: pooled results of 2 phase 3 studies. J Urol. 2009 Jun;181(6):2634-40. doi: 10.1016/j.juro.2009.02.034. Epub 2009 Apr 16. | |
| 23234617 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | Silodosin | Silodosin 8 mg once daily with food |
| FG001 | Placebo | Matching placebo capsule once daily with food |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Other | 1 capsule daily for 12 weeks |
|
| Tucson |
| Arizona |
| United States |
| Anaheim | California | United States |
| Culver City | California | United States |
| Irvine | California | United States |
| La Jolla | California | United States |
| Long Beach | California | United States |
| Newport Beach | California | United States |
| San Diego | California | United States |
| Aurora | Colorado | United States |
| Wheat Ridge | Colorado | United States |
| Waterbury | Connecticut | United States |
| Aventura | Florida | United States |
| Clearwater | Florida | United States |
| Coral Gables | Florida | United States |
| Pensacola | Florida | United States |
| Marietta | Georgia | United States |
| Chicago | Illinois | United States |
| Peoria | Illinois | United States |
| Des Moines | Iowa | United States |
| Saint Joseph | Michigan | United States |
| Edina | Minnesota | United States |
| Missoula | Montana | United States |
| Las Vegas | Nevada | United States |
| Bay Shore | New York | United States |
| Garden City | New York | United States |
| Manhasset | New York | United States |
| New York | New York | United States |
| Staten Island | New York | United States |
| Williamsville | New York | United States |
| Charlotte | North Carolina | United States |
| Salisbury | North Carolina | United States |
| Winston-Salem | North Carolina | United States |
| Cincinnati | Ohio | United States |
| Bethany | Oklahoma | United States |
| Portland | Oregon | United States |
| Lancaster | Pennsylvania | United States |
| Greer | South Carolina | United States |
| Dallas | Texas | United States |
| Salt Lake City | Utah | United States |
| Lakewood | Washington | United States |
| Tacoma | Washington | United States |
| Milwaukee | Wisconsin | United States |
| Marks LS, Gittelman MC, Hill LA, Volinn W, Hoel G. Rapid efficacy of the highly selective alpha(1A)-adrenoceptor antagonist silodosin in men with signs and symptoms of benign prostatic hyperplasia: pooled results of 2 phase 3 studies. J Urol. 2013 Jan;189(1 Suppl):S122-8. doi: 10.1016/j.juro.2012.11.020. |
| 21135869 | Derived | Roehrborn CG, Kaplan SA, Lepor H, Volinn W. Symptomatic and urodynamic responses in patients with reduced or no seminal emission during silodosin treatment for LUTS and BPH. Prostate Cancer Prostatic Dis. 2011 Jun;14(2):143-8. doi: 10.1038/pcan.2010.46. Epub 2010 Dec 7. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Silodosin | Silodosin 8 mg once daily with food |
| BG001 | Placebo | Matching placebo capsule once daily with food |
| 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 | International Prostate Symptom Score (IPSS) | Change from baseline In IPSS at Week 12. IPSS uses a 0 to 35 scale; 0 best, 35 worse symptoms | The number of participants for analysis is determined by Last Observation Carried Forward (LOCF). | Posted | Sep 2009 | Mean | Standard Deviation | Units on a 0 to 35 scale | 12 weeks |
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| Secondary | Maximum Urine Flow Rate (Qmax) | Change from baseline in maximum urine flow rate (Qmax)at Week 12 | The number of participants for analysis is determined by Last Observation Carried Forward (LOCF). | Posted | Mean | Standard Deviation | mL/sec | 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 | Silodosin 8 mg once daily with food | 3 | 233 | 116 | 233 | ||
| EG001 | Placebo | Matching placebo capsule once daily with food | 3 | 228 | 24 | 228 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure congestive | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Enterococcal bacteremia | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Radiculopathy | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Insomnia | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Retrograde ejaculation | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gary Hoel, RPh, PhD, Executive Director of Clinical Research | Watson Laboratories, Inc. | 801-588-6641 | gary.hoel@watson.com |
| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| 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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| >=65 years |
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| Male |
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