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Primary Objective:
To evaluate the dose-response relationship of tarafenacin on efficacy.
Secondary Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tarafenacin 0.2 mg | Experimental | Group 1 |
|
| Tarafenacin 0.4 mg | Experimental | Group 2 |
|
| Placebo | Placebo Comparator | Group 3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tarafenacin 0.2 mg | Drug | Capsule, qd, 12 weeks |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| the change in the number of micturitions per 24 hours from baseline to the end of the 12 weeks treatment period | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline to 12weeks in Number of urgency episodes | 12 weeks | |
| Mean change from baseline to 12weeks in Number of incontinence episodes | 12 weeks | |
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< Inclusion Criteria>
Patient of either sex aged 20 to 80 years (both inclusive);
Patients suffering from Overactive Bladder. based on cardinal symptoms (urgency, nocturia, frequency with or without urge incontinence) for at least 6 months prior to inclusion;
Patients who document the following symptoms in a 3-day diary card during the 14 day placebo run-in period
<Exclusion Criteria>
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| Name | Affiliation | Role |
|---|---|---|
| Myung-Soo Choo, Professor | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | 138-736 | South Korea |
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| Drug |
Capsule, qd, 12 weeks |
|
| Tarafenacin 0.4 mg | Drug | Capsule, qd, 12 weeks |
|
| Mean change from baseline to 12weeks in Number of nocturia episodes |
| 12weeks |
| Mean change from baseline to 12weeks in Volume of urine passed per void | 12weeks |
| Mean change from baseline to 12weeks in score of King's Health Questionnaire | 12weeks |
| 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 |
| 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 |
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