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

Overactive Bladder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03566134
• Other study ID #: DA8010_OAB_II
• Status: Completed
• Phase: Phase 2
• Start date: July 10, 2018
• Est. completion date: December 27, 2019

Study information

• Verified date: July 2018
• Source: Dong-A ST Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 306
• Est. completion date: December 27, 2019
• Est. primary completion date: December 27, 2019
• 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 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

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