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

NCT05282069 | Completed Phase 3

• 1 other identifier: DA8010_OAB_III
• Study Type: interventional
• Target: 607
• Locations: 1 country
• Sites: 1

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.

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

  4, 8 and 12 weeks

Study Arms (4)

Placebo

PLACEBO COMPARATOR

DA-8010 placebo + Solifenacin succinate placebo

Drug: DA-8010 Placebo; Drug: Solifenacin succinate placebo

DA-8010 2.5mg

EXPERIMENTAL

DA-8010 2.5mg + Solifenacin succinate placebo

Drug: DA-8010 2.5mg; Drug: Solifenacin succinate placebo

DA-8010 5mg

EXPERIMENTAL

DA-8010 5mg + Solifenacin succinate placebo

Drug: DA-8010 5mg; Drug: Solifenacin succinate placebo

Solifenacin 5mg

ACTIVE COMPARATOR

DA-8010 placebo + Solifenacin succinate 5mg

Drug: DA-8010 Placebo; Drug: Solifenacin 5mg

Interventions

DA-8010 Placebo DRUG

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

Placebo; Solifenacin 5mg

DA-8010 2.5mg DRUG

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

DA-8010 2.5mg

DA-8010 5mg DRUG

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

DA-8010 5mg

Solifenacin 5mg DRUG

Participants receive solifenacin 5 mg orally once a day.

Solifenacin 5mg

Solifenacin succinate placebo DRUG

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

DA-8010 2.5mg; DA-8010 5mg; Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dong-A ST Co., Ltd.: lead

Study Sites (1)

Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

DA-8010; Solifenacin Succinate

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2022
• First Posted: March 16, 2022
• Study Start: May 12, 2022
• Primary Completion: November 1, 2023
• Study Completion: May 29, 2024
• Last Updated: June 26, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share

Locations

KR (1)