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The purpose of this study is to assess if patients treated with silodosin will have a higher spontaneous passage rate of their ureteral stone than those treated with placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| silodsosin | Active Comparator |
| |
| placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| silodosin | Drug | one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Spontaneous Stone Passage (Distal Stones) Without Need for Emergency Department Visits, Hospital Admissions, Surgical Intervention, or Other Interventional Procedures. | The primary efficacy variable is the occurrence of spontaneous distal stone passage within 4 weeks, as determined by radiography. For this outcome measure, analysis includes only those stones located in the distal ureter. | 4 weeks |
| Spontaneous Stone Passage (All Stones) Without Need for Emergency Department Visits, Hospital Admissions, Surgical Intervention, or Other Interventional Procedures. | The primary efficacy variable is the occurrence of spontaneous stone passage within 4 weeks, as determined by radiography. For this outcome measure, analysis includes all ureteral stones, regardless of location in the ureter. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Spontaneous Stone Passage (Distal Stones) | Time to stone passage for distally-located stones is assessed by entries in subject diaries. | 4 weeks |
| Outpatient Narcotic Analgesic Use for Pain Relief |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott Olsen, MPH | Watson Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Watson Investigational Site | Birmingham | Alabama | United States | |||
| Watson Investigational Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Silodsosin | silodosin: one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks |
| FG001 | Placebo | placebo: one placebo capsule orally, once daily, with food for up to 4 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| placebo |
| Drug |
one placebo capsule orally, once daily, with food for up to 4 weeks |
|
Narcotic analgesic use was assessed through a subject diary. Analysis was performed on the number of days with analgesic use.
| 4 weeks |
| Change From Baseline in Average Score on the Brief Pain Inventory (Distal Stones) | At each study visit, subjects were given a Brief Pain Inventory (BPI) Questionnaire to complete. The BPI collects subject-reported pain severity scores and assesses impact of pain upon the subject's daily life, on a 10-point scale (with 10 being the greatest severity/impact). Analysis was change from baseline to week 4. | 4 weeks |
| Time to Spontaneous Stone Passage (All Stones) | Time to stone passage for all ureteral stones (regardless of location) is assessed by entries in subject diaries. | 4 weeks |
| Anchorage |
| Alaska |
| United States |
| Watson Investigative Site | Mission Hills | California | United States |
| Watson Investigational Site | Murrieta | California | United States |
| Watson Investigational Site | San Diego | California | United States |
| Watson Investigational Site | Daytona Beach | Florida | United States |
| Watson Investigational Site | Gainesville | Florida | United States |
| Watson Investigational Site | Orange City | Florida | United States |
| Watson Investigative Site | Overland Park | Kansas | United States |
| Watson Investigative Site | North Kansas City | Missouri | United States |
| Watson Investigational Site | Hackensack | New Jersey | United States |
| Watson Investigational Site | Mount Laurel | New Jersey | United States |
| Watson Investigational Site | Sewell | New Jersey | United States |
| Watson Investigational Site | Voorhees Township | New Jersey | United States |
| Watson Investigational Site | Albany | New York | United States |
| Watson Investigational Site | Garden City | New York | United States |
| Watson Investigational Site | New York | New York | United States |
| Watson Investigational Site | Plainview | New York | United States |
| Watson Investigational Site | Syracuse | New York | United States |
| Watson Investigational Site | Cincinnati | Ohio | United States |
| Watson Investigational Site | Columbus | Ohio | United States |
| Watson Investigational Site | Bala-Cynwyd | Pennsylvania | United States |
| Watson Investigational Site | Lancaster | Pennsylvania | United States |
| Watson Investigational Site | Myrtle Beach | South Carolina | United States |
| Watson Investigational Site | Dallas | Texas | United States |
| Watson Investigational Site | San Antonio | Texas | United States |
| Watson Investigational Site | Virginia Beach | Virginia | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Silodsosin | silodosin: one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks |
| BG001 | Placebo | placebo: one placebo capsule orally, once daily, with food for up to 4 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | 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 | Spontaneous Stone Passage (Distal Stones) Without Need for Emergency Department Visits, Hospital Admissions, Surgical Intervention, or Other Interventional Procedures. | The primary efficacy variable is the occurrence of spontaneous distal stone passage within 4 weeks, as determined by radiography. For this outcome measure, analysis includes only those stones located in the distal ureter. | Those subjects in the ITT population (defined as randomized and received at least one dose of study drug) with stones located in the distal ureter (determined by radiography) were included in this analysis. The number of ITT subjects with distal stones was 52/115 in the 8 mg silodosin treatment arm and 59/117 in the placebo treatment arm. | Posted | Number | participants | 4 weeks |
|
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| |||||||||||||||||||||||||||||
| Secondary | Time to Spontaneous Stone Passage (Distal Stones) | Time to stone passage for distally-located stones is assessed by entries in subject diaries. | Those subjects in the ITT population (defined as randomized and received at least one dose of study drug) with stones located in the distal ureter (determined by radiography) were included in this analysis. The number of ITT subjects with distal stones was 52/115 in the 8 mg silodosin treatment arm and 59/117 in the placebo treatment arm. | Posted | Mean | Standard Error | days | 4 weeks |
|
| |||||||||||||||||||||||||||||
| Secondary | Outpatient Narcotic Analgesic Use for Pain Relief | Narcotic analgesic use was assessed through a subject diary. Analysis was performed on the number of days with analgesic use. | ITT population | Posted | Mean | Standard Deviation | Days | 4 weeks |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Average Score on the Brief Pain Inventory (Distal Stones) | At each study visit, subjects were given a Brief Pain Inventory (BPI) Questionnaire to complete. The BPI collects subject-reported pain severity scores and assesses impact of pain upon the subject's daily life, on a 10-point scale (with 10 being the greatest severity/impact). Analysis was change from baseline to week 4. | Those subjects in the ITT population (defined as randomized and received at least one dose of study drug) with stones located in the distal ureter (determined by radiography) were included in this analysis. The number of ITT subjects with distal stones was 52/115 in the 8 mg silodosin treatment arm and 59/117 in the placebo treatment arm. | Posted | Mean | Standard Deviation | units on a scale | 4 weeks |
|
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| Primary | Spontaneous Stone Passage (All Stones) Without Need for Emergency Department Visits, Hospital Admissions, Surgical Intervention, or Other Interventional Procedures. | The primary efficacy variable is the occurrence of spontaneous stone passage within 4 weeks, as determined by radiography. For this outcome measure, analysis includes all ureteral stones, regardless of location in the ureter. | This endpoint analyzed all subjects in the ITT population, defined as randomized and received at least one dose of study drug (115 in the 8 mg silodosin arm, 117 in the placebo arm) | Posted | Number | participants | 4 weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | Time to Spontaneous Stone Passage (All Stones) | Time to stone passage for all ureteral stones (regardless of location) is assessed by entries in subject diaries. | ITT population | Posted | Mean | Standard Error | days | 4 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 | Silodsosin | silodosin: one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks | 2 | 119 | 27 | 119 | ||
| EG001 | Placebo | placebo: one placebo capsule orally, once daily, with food for up to 4 weeks | 2 | 120 | 8 | 120 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Renal colic | Renal and urinary disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Retrograde ejaculation | Reproductive system and breast disorders |
| |||
| Nausea | Gastrointestinal disorders |
| |||
| Dizziness | Nervous system disorders |
| |||
| Headache | Nervous system disorders |
| |||
| Vomiting | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gary Hoel, RPh PhD, VP Global Brands Clinical Research | Watson Laboratories, Inc. | 801 588-6641 | gary.hoel@watson.com |
| ID | Term |
|---|---|
| D014514 | Ureteral Calculi |
| D007669 | Kidney Calculi |
| D052878 | Urolithiasis |
| D056844 | Renal Colic |
| ID | Term |
|---|---|
| D053039 | Ureterolithiasis |
| D014515 | Ureteral Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C095285 | silodosin |
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| Male |
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