A Study to Evaluate the Efficacy and Safety of DA-8010 in Patients With Overactive Bladder
NCT ID: NCT05282069
Last Updated: 2024-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
607 participants
INTERVENTIONAL
2022-05-12
2024-05-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
DA-8010 placebo + Solifenacin succinate placebo
DA-8010 Placebo
Participants receive placebo to match DA-8010 orally once a day.
Solifenacin succinate placebo
Participants receive placebo to match solifenacin 5 mg orally once a day.
DA-8010 2.5mg
DA-8010 2.5mg + Solifenacin succinate placebo
DA-8010 2.5mg
Participants receive DA-8010 2.5mg orally once a day.
Solifenacin succinate placebo
Participants receive placebo to match solifenacin 5 mg orally once a day.
DA-8010 5mg
DA-8010 5mg + Solifenacin succinate placebo
DA-8010 5mg
Participants receive DA-8010 5mg orally once a day.
Solifenacin succinate placebo
Participants receive placebo to match solifenacin 5 mg orally once a day.
Solifenacin 5mg
DA-8010 placebo + Solifenacin succinate 5mg
DA-8010 Placebo
Participants receive placebo to match DA-8010 orally once a day.
Solifenacin 5mg
Participants receive solifenacin 5 mg orally once a day.
Interventions
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DA-8010 Placebo
Participants receive placebo to match DA-8010 orally once a day.
DA-8010 2.5mg
Participants receive DA-8010 2.5mg orally once a day.
DA-8010 5mg
Participants receive DA-8010 5mg orally once a day.
Solifenacin 5mg
Participants receive solifenacin 5 mg orally once a day.
Solifenacin succinate placebo
Participants receive placebo to match solifenacin 5 mg orally once a day.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
19 Years
ALL
No
Sponsors
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Dong-A ST Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Severance Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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DA8010_OAB_III
Identifier Type: -
Identifier Source: org_study_id
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