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The purpose of this study is to evaluate the efficacy and the safety of silodosin in urinary calculi patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| silodosin, arm 1 | Experimental |
| |
| silodosin, arm 2 | Experimental |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| silodosin | Drug |
| ||
| silodosin |
| Measure | Description | Time Frame |
|---|---|---|
| Spontaneous stone passage rate | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to spontaneous stone passage | 4 weeks | |
| Analgesic use | 4 weeks | |
| Pain severity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tatsuro Takei | Clinical Development Department, Kissei pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Japan | Tokyo and Other Japanese City | Japan |
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| ID | Term |
|---|---|
| D014545 | Urinary Calculi |
| ID | Term |
|---|---|
| D052878 | Urolithiasis |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C095285 | silodosin |
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|
| placebo | Drug |
|
| 4 weeks |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |