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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03566134

Enrollment

306

Registered

2018-06-21

Start date

2018-07-10

Completion date

2019-12-27

Last updated

2020-02-07

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

Conditions

Overactive Bladder

Brief 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

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 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

Design outcomes

Primary

Measure	Time frame	Description
Change From Baseline in mean number of micturitions per 24 hours	12 weeks	Change from baseline to Week 12 in mean number of micturitions per 24 hours

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026