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

• Status: Not yet recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dong-A ST Co., Ltd.
• Treatments: DA-8010; Solifenacin Succinate

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 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