Status:
COMPLETED
A Study to Evaluate the Efficacy and Safety of DA-8010 in Patients With Overactive Bladder
Lead Sponsor:
Dong-A ST Co., Ltd.
Conditions:
Overactive Bladder
Eligibility:
All Genders
19+ years
Phase:
PHASE3
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 29 2024
Estimated Enrollment :
607 Patients enrolled
Trial Details
Trial ID
NCT05282069
Start Date
May 12 2022
End Date
May 29 2024
Last Update
June 26 2024
Active Locations (1)
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1
Severance Hospital
Seoul, South Korea