A Study to Evaluate the Efficacy and Safety of DA-8010 in Patients With Overactive Bladder

Study Overview
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Brief Summary
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This study will evaluate the efficacy and safety of DA-8010 in patients with overactive bladder.

Official Title
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A Multicenter, Double-blind, Placebo-controlled and Active-reference, Randomized, Parallel, Therapeutic Confirmatory Clinical Study to Evaluate the Efficacy and Safety of DA-8010 in Patients With Overactive Bladder

Conditions
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Overactive Bladder

Intervention / Treatment
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* Drug: DA-8010 Placebo
* Drug: DA-8010 2.5mg
* Drug: DA-8010 5mg
* Drug: Solifenacin 5mg
* Drug: Solifenacin succinate placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Main Inclusion at Screening (Visit 1): Men and women 19 years or older with OAB symptoms for ≥ 3 months. Subject who is willing and able to complete the voiding diary correctly. Subject who is willing and able to provide informed consent indicating that they understand the purpose and procedures required for the study Exclusion Criteria: Main Exclusion at Screening (Visit 1): Clinically significant stress urinary incontinence or mixed urinary incontinence where stress is the predominant factor Subject who has Injury or neurodegenerative disease which is able to effect on lower urinary tract and nerves Subject with diabetes insipidus, urinary stone, urinary tract infection, interstitial cystitis, recurrent urinary tract infection, pelvic organ prolapse or neurogenic bladder Clinically significant benign prostatic hyperplasia at the discretion of the investigator Had bladder or lower urinary tract surgery within 12 months from the screening visit Medical history of malignant tumor in urinary system or pelvic organs >150 mL of post-void residual volume in the screening test

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>DA-8010 placebo + Solifenacin succinate placebo | Drug: DA-8010 Placebo<br>* Participants receive placebo to match DA-8010 orally once a day.<br>Drug: Solifenacin succinate placebo<br>* Participants receive placebo to match solifenacin 5 mg orally once a day.<br>|
| Experimental: DA-8010 2.5mg<br>DA-8010 2.5mg + Solifenacin succinate placebo | Drug: DA-8010 2.5mg<br>* Participants receive DA-8010 2.5mg orally once a day.<br>Drug: Solifenacin succinate placebo<br>* Participants receive placebo to match solifenacin 5 mg orally once a day.<br>|
| Experimental: DA-8010 5mg<br>DA-8010 5mg + Solifenacin succinate placebo | Drug: DA-8010 5mg<br>* Participants receive DA-8010 5mg orally once a day.<br>Drug: Solifenacin succinate placebo<br>* Participants receive placebo to match solifenacin 5 mg orally once a day.<br>|
| Active Comparator: Solifenacin 5mg<br>DA-8010 placebo + Solifenacin succinate 5mg | Drug: DA-8010 Placebo<br>* Participants receive placebo to match DA-8010 orally once a day.<br>Drug: Solifenacin 5mg<br>* Participants receive solifenacin 5 mg orally once a day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |