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

• Status: Completed
• Trial end date: 2019-12-27
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• 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 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