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Completed

NCT Number: NCT03566134

A Therapeutic Exploratory Clinical Study of DA-8010 in Patients With Overactive Bladder

A Therapeutic Exploratory Clinical Study to evaluate the efficacy and safety of DA-8010 in Patients with Overactive Bladder and to determine the optimal dose of DA-8010

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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 2

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 micturition 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

  • Clinically significant Stress urinary incontinence or Mixed urinary incontinence where stress is the predominant factor
  • Diagnosed with interstitial cystitis or bladder pain syndrome
  • Clinically significant pelvic organ prolapse
  • Subject who has neurologic status which is able to effect vesical function, such as multiple sclerosis, Spinal Injury or Parkinson's disease
  • Medical history of malignant tumor in urinary system or pelvic organs
  • Clinically significant bladder outlet obstruction or more than 200mL of post-void residual volume

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 mean number of micturitions per 24 hours

    Time frame: 12 weeks

    Change from baseline to Week 12 in mean number of micturitions per 24 hours

Sponsors and collaborators

Lead sponsor

Dong-A ST Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 21, 2018
Registry last updated
Feb 7, 2020

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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