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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 Internation 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/Day 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 |
|---|---|---|
| Measuring Change From Baseline in International Prostate Symptom Score (IPSS) at 12 Weeks | International prostate symptom score: Measuring prostate signs and symptoms asociated with benign prostatic hyperplasia on a 0 to 35 scale; 0 best, 35 worst symptoms | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Maximum Urine Flow Rate (Qmax) at 12 Weeks | Baseline and 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 |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19371887 | Background | 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 | One capsule daily for 12 weeks |
|
| Carmichael |
| California |
| United States |
| Fresno | California | United States |
| Laguna Woods | California | United States |
| San Bernardino | California | United States |
| Tarzana | California | United States |
| Torrance | California | United States |
| New Port Richey | Florida | United States |
| Ocala | Florida | United States |
| Orlando | Florida | United States |
| Plantation | Florida | United States |
| Tampa | Florida | United States |
| West Palm Beach | Florida | United States |
| Chicago | Illinois | United States |
| Melrose Park | Illinois | United States |
| Evansville | Indiana | United States |
| Fort Wayne | Indiana | United States |
| Overland Park | Kansas | United States |
| Greenbelt | Maryland | United States |
| Boston | Massachusetts | United States |
| Jackson | Mississippi | United States |
| Kansas City | Missouri | United States |
| Lawrenceville | New Jersey | United States |
| Voorhees Township | New Jersey | United States |
| Albuquerque | New Mexico | United States |
| Albany | New York | United States |
| Garden City | New York | United States |
| Kingston | New York | United States |
| Poughkeepsie | New York | United States |
| Concord | North Carolina | United States |
| Cincinnati | Ohio | United States |
| Portland | Oregon | United States |
| Providence | Rhode Island | United States |
| Mt. Pleasant | South Carolina | United States |
| Myrtle Beach | South Carolina | United States |
| Austin | Texas | United States |
| Dallas | Texas | United States |
| San Antonio | Texas | United States |
| Norfolk | Virginia | United States |
| Seattle | Washington | United States |
| Tacoma | Washington | United States |
| Madison | 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 |
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| 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 | Measuring Change From Baseline in International Prostate Symptom Score (IPSS) at 12 Weeks | International prostate symptom score: Measuring prostate signs and symptoms asociated with benign prostatic hyperplasia on a 0 to 35 scale; 0 best, 35 worst symptoms | The number of participants for analysis is determined by Last Observation Carried Forward (LOCF). | Posted | Sep 2009 | Mean | Standard Deviation | Units on a scale | Baseline and 12 weeks |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Maximum Urine Flow Rate (Qmax) at 12 Weeks | Posted | Sep 2009 | Mean | Standard Deviation | mL/min | Baseline and 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 | 99 | 233 | ||
| EG001 | Placebo | Matching placebo capsule once daily with food | 4 | 229 | 15 | 229 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrioventricular block third degree | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Enterocolitis bacterial | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Lesion excision | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Retrograde ejaculation | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Prostatic specific antigen increased | Investigations | 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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