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Tamsulosin (Flowmax)is approved by the FDA for the treatment for enlarged prostate. Several studies regarding the use of Tamsulosin for the treatment of lower kidney stones have been carried out in the non-Emergency Department setting. This study will compare Tamsulosin 0.4 mg with placebo in regards to rate and time of stone passing and will also look at amount of pain. The purpose of this study is to compare the usefulness of Tamsulosin versus placebo on time to stone passage and pain relief in Emergency Department patients with kidney stones.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tamsulosin | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flowmax | Drug | 0.4 mg once a day until stone passage total = 9 tablets |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time of Stone Passage | Upon discharge, patient must be able to take the medication for 10 days and strain his/her urine. Patient must log the date and time of stone passage, if known. | 10 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc Pollack, MD, PhD | WellSpan Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| York Hospital Emergency Department | York | Pennsylvania | 17405 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tamsulosin | Flowmax: 0.4 mg once a day until stone passage total = 9 tablets |
| FG001 | Placebo | placebo: cornstarch |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
results not available
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| ID | Title | Description |
|---|---|---|
| BG000 | Tamsulosin | Flowmax: 0.4 mg once a day until stone passage total = 9 tablets |
| BG001 | Placebo | placebo: cornstarch |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Time of Stone Passage | Upon discharge, patient must be able to take the medication for 10 days and strain his/her urine. Patient must log the date and time of stone passage, if known. | Posted | Median | Inter-Quartile Range | hours | 10 Days |
|
|
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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 | Tamsulosin | Flowmax: 0.4 mg once a day until stone passage total = 9 tablets |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Barbara Stahlman MS, Clinical Research Associate | WellSpan Health | 717-851-2450 | bstahlman@wellspan.org |
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| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| D053039 | Ureterolithiasis |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| placebo |
| Drug |
cornstarch |
|
| BG002 |
| Total |
Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | Placebo | placebo: cornstarch | 0 | 25 | 0 | 25 |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014515 | Ureteral Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |