A Therapeutic Exploratory Clinical Study of DA-8010 in Patients With Overactive Bladder

Study Overview
=================
Brief Summary
-----------------
A Therapeutic Exploratory Clinical Study to evaluate the efficacy and safety of DA-8010 in Patients with Overactive Bladder and to determine the optimal dose of DA-8010

Official Title
-----------------
A Therapeutic Exploratory Clinical Study to Evaluate the Efficacy and Safety of DA-8010 in Patients With Overactive Bladder

Conditions
-----------------
Overactive Bladder

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


Participation Criteria
=================
Eligibility Criteria
-----------------
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 micturition 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: Clinically significant Stress urinary incontinence or Mixed urinary incontinence where stress is the predominant factor Diagnosed with interstitial cystitis or bladder pain syndrome Clinically significant pelvic organ prolapse Subject who has neurologic status which is able to effect vesical function, such as multiple sclerosis, Spinal Injury or Parkinson's disease Medical history of malignant tumor in urinary system or pelvic organs Clinically significant bladder outlet obstruction or more than 200mL of post-void residual volume

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in mean number of micturitions per 24 hours | Change from baseline to Week 12 in mean number of micturitions per 24 hours | 12 weeks |