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This study will evaluate the efficacy and safety of DA-8010 in patients with overactive bladder for 12 weeks as double-blind, placebo-controlled and active-reference study, and also will evaluate the long-term safety of DA-8010 for 52 weeks in patients with overactive bladder as open-label study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | DA-8010 placebo + Solifenacin succinate placebo |
|
| DA-8010 2.5mg | Experimental | DA-8010 2.5mg + Solifenacin succinate placebo |
|
| DA-8010 5mg | Experimental | DA-8010 5mg + Solifenacin succinate placebo |
|
| Solifenacin 5mg | Active Comparator | DA-8010 placebo + Solifenacin succinate 5mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DA-8010 Placebo | Drug | Participants receive placebo to match DA-8010 orally once a day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the mean number of micturitions per 24 hours at 12 weeks | Change from baseline in the mean number of micturitions per 24 hours at 12 weeks | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the mean number of micturitions per 24 hours at 4 and 8 weeks | Change from baseline in the mean number of micturitions per 24 hours at 4 and 8 weeks | 4 and 8 weeks |
| Change from baseline in the mean number of urinary urgency(Grade 2, 3, 4) per 24 hours at 4, 8 and 12 weeks |
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Inclusion Criteria:
Main Inclusion at Screening (Visit 1):
Exclusion Criteria:
Main Exclusion at Screening (Visit 1):
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital | Seoul | 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 |
|---|---|
| C000630740 | DA-8010 |
| D000069464 | Solifenacin Succinate |
| ID | Term |
|---|---|
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006571 | Heterocyclic Compounds |
| D044005 | Tetrahydroisoquinolines |
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| DA-8010 2.5mg | Drug | Participants receive DA-8010 2.5mg orally once a day. |
|
| DA-8010 5mg | Drug | Participants receive DA-8010 5mg orally once a day. |
|
| Solifenacin 5mg | Drug | Participants receive solifenacin 5 mg orally once a day. |
|
| Solifenacin succinate placebo | Drug | Participants receive placebo to match solifenacin 5 mg orally once a day. |
|
Change from baseline in the mean number of urinary urgency(Grade 2, 3, 4) per 24 hours at 4, 8 and 12 weeks |
| 4, 8 and 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 |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |