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

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.

Study Overview

• Status: Completed
• Conditions: Overactive Bladder
• Intervention / Treatment: Drug: DA-8010 Placebo; Drug: Solifenacin succinate placebo; Drug: DA-8010 2.5mg; Drug: DA-8010 5mg; Drug: Solifenacin 5mg

• Study Type: Interventional
• Enrollment (Actual): 607
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; DA-8010 placebo + Solifenacin succinate placebo	Drug: DA-8010 Placebo; Participants receive placebo to match DA-8010 orally once a day.; Drug: Solifenacin succinate placebo; Participants receive placebo to match solifenacin 5 mg orally once a day.
Experimental: DA-8010 2.5mg; DA-8010 2.5mg + Solifenacin succinate placebo	Drug: Solifenacin succinate placebo; Participants receive placebo to match solifenacin 5 mg orally once a day.; Drug: DA-8010 2.5mg; Participants receive DA-8010 2.5mg orally once a day.
Experimental: DA-8010 5mg; DA-8010 5mg + Solifenacin succinate placebo	Drug: Solifenacin succinate placebo; Participants receive placebo to match solifenacin 5 mg orally once a day.; Drug: DA-8010 5mg; Participants receive DA-8010 5mg orally once a day.
Active Comparator: Solifenacin 5mg; DA-8010 placebo + Solifenacin succinate 5mg	Drug: DA-8010 Placebo; Participants receive placebo to match DA-8010 orally once a day.; Drug: Solifenacin 5mg; Participants receive solifenacin 5 mg orally once a day.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 micturitions per 24 hours at 4 and 8 weeks	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	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

Collaborators and Investigators

• Sponsor: Dong-A ST Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2022
• Primary Completion (Actual): November 1, 2023
• Study Completion (Actual): May 29, 2024

Study Registration Dates

• First Submitted: March 7, 2022
• First Submitted That Met QC Criteria: March 7, 2022
• First Posted (Actual): March 16, 2022

Study Record Updates

• Last Update Posted (Actual): June 26, 2024
• Last Update Submitted That Met QC Criteria: June 24, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder, Overactive; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Urological Agents; Solifenacin Succinate; DA-8010
• Other Study ID Numbers: DA8010_OAB_III

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No