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

Overactive Bladder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05282069
• Other study ID #: DA8010_OAB_III
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: May 12, 2022
• Est. completion date: May 2024

Study information

• Verified date: August 2023
• Source: Dong-A ST Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the efficacy and safety of DA-8010 in patients with overactive bladder.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 607
• Est. completion date: May 2024
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Dong-A ST Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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