Back to resultsA Therapeutic Exploratory Clinical Study of DA-8010 in Patients With Overactive Bladder
Primary Purpose
Overactive Bladder
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
DA-8010 Placebo
DA-8010 2.5mg
DA-8010 5mg
Solifenacin 5mg
Solifenacin succinate placebo
Sponsored by
About this trial
This is an interventional treatment trial for Overactive Bladder
Eligibility Criteria
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
Sites / Locations
- Severance Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Experimental
Active Comparator
Arm Label
Placebo
DA-8010 2.5mg
DA-8010 5mg
Solifenacin 5mg
Arm Description
DA-8010 placebo + Solifenacin succinate placebo
DA-8010 2.5mg + Solifenacin succinate placebo
DA-8010 5mg + Solifenacin succinate placebo
DA-8010 placebo + Solifenacin succinate 5mg
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03566134
Brief Title
A Therapeutic Exploratory Clinical Study of DA-8010 in Patients With Overactive Bladder
Official Title
A Therapeutic Exploratory Clinical Study to Evaluate the Efficacy and Safety of DA-8010 in Patients With Overactive Bladder
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
July 10, 2018 (Actual)
Primary Completion Date
December 27, 2019 (Actual)
Study Completion Date
December 27, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dong-A ST Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
306 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
DA-8010 placebo + Solifenacin succinate placebo
Arm Title
DA-8010 2.5mg
Arm Type
Experimental
Arm Description
DA-8010 2.5mg + Solifenacin succinate placebo
Arm Title
DA-8010 5mg
Arm Type
Experimental
Arm Description
DA-8010 5mg + Solifenacin succinate placebo
Arm Title
Solifenacin 5mg
Arm Type
Active Comparator
Arm Description
DA-8010 placebo + Solifenacin succinate 5mg
Intervention Type
Drug
Intervention Name(s)
DA-8010 Placebo
Intervention Description
Participants receive placebo to match DA-8010 orally once a day.
Intervention Type
Drug
Intervention Name(s)
DA-8010 2.5mg
Intervention Description
Participants receive DA-8010 2.5mg orally once a day.
Intervention Type
Drug
Intervention Name(s)
DA-8010 5mg
Intervention Description
Participants receive DA-8010 5mg orally once a day.
Intervention Type
Drug
Intervention Name(s)
Solifenacin 5mg
Intervention Description
Participants receive solifenacin 5 mg orally once a day.
Intervention Type
Drug
Intervention Name(s)
Solifenacin succinate placebo
Intervention Description
Participants receive placebo to match solifenacin 5 mg orally once a day.
Primary Outcome Measure Information:
Title
Change From Baseline in mean number of micturitions per 24 hours
Description
Change from baseline to Week 12 in mean number of micturitions per 24 hours
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Severance Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Therapeutic Exploratory Clinical Study of DA-8010 in Patients With Overactive Bladder
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