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

Dong-A ST

Status and phase: Completed; Phase 3

Conditions: Overactive Bladder

Treatments: Drug: Solifenacin succinate placebo; Drug: DA-8010 5mg; Drug: DA-8010 Placebo; Drug: DA-8010 2.5mg; Drug: Solifenacin 5mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT05282069

DA8010_OAB_III

Details and patient eligibility

About

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.

Enrollment: 607 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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607 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

DA-8010 placebo + Solifenacin succinate placebo

Treatment:

Drug: DA-8010 Placebo

Drug: Solifenacin succinate placebo

DA-8010 2.5mg

Experimental group

Description:

DA-8010 2.5mg + Solifenacin succinate placebo

Treatment:

Drug: DA-8010 2.5mg

Drug: Solifenacin succinate placebo

DA-8010 5mg

Experimental group

Description:

DA-8010 5mg + Solifenacin succinate placebo

Treatment:

Drug: DA-8010 5mg

Drug: Solifenacin succinate placebo

Solifenacin 5mg

Active Comparator group

Description:

DA-8010 placebo + Solifenacin succinate 5mg

Treatment:

Drug: Solifenacin 5mg

Drug: DA-8010 Placebo