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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05282069

Enrollment

607

Registered

2022-03-16

Start date

2022-05-12

Completion date

2024-05-29

Last updated

2024-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overactive Bladder

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 long-term safety of DA-8010 for 52 weeks in patients with overactive bladder as open-label study.

Interventions

DRUGDA-8010 Placebo

Participants receive placebo to match DA-8010 orally once a day.

DRUGDA-8010 2.5mg

Participants receive DA-8010 2.5mg orally once a day.

DRUGDA-8010 5mg

Participants receive DA-8010 5mg orally once a day.

DRUGSolifenacin 5mg

Participants receive solifenacin 5 mg orally once a day.

DRUGSolifenacin succinate placebo

Participants receive placebo to match solifenacin 5 mg orally once a day.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Change from baseline in the mean number of micturitions per 24 hours at 12 weeks	12 weeks	Change from baseline in the mean number of micturitions per 24 hours at 12 weeks

Secondary

Measure	Time frame	Description
Change from baseline in the mean number of micturitions per 24 hours at 4 and 8 weeks	4 and 8 weeks	Change from baseline in the mean number of micturitions per 24 hours at 4 and 8 weeks
Change from baseline in the mean number of urinary urgency(Grade 2, 3, 4) per 24 hours at 4, 8 and 12 weeks	4, 8 and 12 weeks	Change from baseline in the mean number of urinary urgency(Grade 2, 3, 4) per 24 hours at 4, 8 and 12 weeks

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026