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

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

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.

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