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| Name | Class |
|---|---|
| Kyorin Pharmaceutical Co.,Ltd | INDUSTRY |
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To evaluate the efficacy and safety after 12 weeks oral administration of Imidafenacin 0.1mg b.i.d versus Fesoterodine 4mg once daily for the urge incontinence and/or increased urinary frequency associated with urgency as may occur in patients with overactive bladder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Imidafenacin | Experimental |
| |
| Fesoterodine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imidafenacin | Drug | Tablet, 12 weeks twice daily |
| |
| Fesoterodine |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in daily mean urination frequency between the end of treatment period(Week 12) and the end of observation period(Baseline, Week 0) | up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in daily mean Urinary incontinence frequency between each evaluation time(treatment period Week 4, Week 8, Week 12) and the end of observation period(Baseline, week 0) | up to 12 weeks | |
| Difference in daily mean urge incontinence frequency between each evaluation time(treatment period Week 4, Week 8, Week 12) and the end of observation period(Baseline, week 0) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| KYU-SUNG LEE, M.D. | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | 135-710 | South Korea |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C120953 | imidafenacin |
| C526675 | fesoterodine |
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| Drug |
Tablet, 12 weeks once daily |
|
| up to 12 weeks |
| Difference in daily mean nocturia frequency between each evaluation time(treatment period Week 4, Week 8, Week 12) and the end of observation period(Baseline, week 0) | up to 12 weeks |
| Difference in daily mean urination frequency between each evaluation time(treatment period Week 4, Week 8) and the end of observation period(baselien, week 0) | up to 12 weeks |
| Difference in QoL score between each evaluation time(treatment period Week 4, Week 8, Week 12) and the end of observation period(Baseline, week 0) | up to 12 weeks |
| Adverse events | up to 24 weeks |
| laboratory test | up to 12 weeks |
| vital signs | up to 12 weeks |
| residual urine | up to 12 weeks |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |