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NCT Number: NCT05282069

A 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.

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Key information

Conditions

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

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Severance Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DA-8010 Placebo

Drug

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

DA-8010 2.5mg

Drug

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

DA-8010 5mg

Drug

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

Solifenacin 5mg

Drug

Participants receive solifenacin 5 mg orally once a day.

Solifenacin succinate placebo

Drug

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

Primary outcomes

  1. Change from baseline in the mean number of micturitions per 24 hours at 12 weeks

    Time frame: 12 weeks

    Change from baseline in the mean number of micturitions per 24 hours at 12 weeks

Secondary outcomes

  1. Change from baseline in the mean number of micturitions per 24 hours at 4 and 8 weeks

    Time frame: 4 and 8 weeks

    Change from baseline in the mean number of micturitions per 24 hours at 4 and 8 weeks

  2. Change from baseline in the mean number of urinary urgency(Grade 2, 3, 4) per 24 hours at 4, 8 and 12 weeks

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Dong-A ST Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Mar 16, 2022
Registry last updated
Jun 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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