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

Phase 3

Completed

• Conditions: Overactive Bladder
• Interventions: Drug: DA-8010 Placebo; Drug: DA-8010 2.5mg; Drug: DA-8010 5mg; Drug: Solifenacin succinate placebo; Drug: Solifenacin 5mg

• Registration Number: NCT05282069
• Lead Sponsor: Dong-A ST Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-07
• Study First Submitted QC: 2022-03-07
• Study First Posted: 2022-03-16
• Study Start: 2022-05-12
• Primary Completion: 2023-11-01
• Study Completion: 2024-05-29
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-24
• Last Update Posted: 2024-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 607

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	DA-8010 Placebo	DA-8010 placebo + Solifenacin succinate placebo
Placebo	Solifenacin succinate placebo	DA-8010 placebo + Solifenacin succinate placebo
DA-8010 2.5mg	DA-8010 2.5mg	DA-8010 2.5mg + Solifenacin succinate placebo
DA-8010 5mg	DA-8010 5mg	DA-8010 5mg + Solifenacin succinate placebo
Solifenacin 5mg	DA-8010 Placebo	DA-8010 placebo + Solifenacin succinate 5mg
Solifenacin 5mg	Solifenacin 5mg	DA-8010 placebo + Solifenacin succinate 5mg
DA-8010 2.5mg	Solifenacin succinate placebo	DA-8010 2.5mg + Solifenacin succinate placebo
DA-8010 5mg	Solifenacin succinate placebo	DA-8010 5mg + Solifenacin succinate placebo

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of