Status:
COMPLETED
A Phase 2 Study of TAS-303 in Female Patients With Stress Urinary Incontinence
Lead Sponsor:
Taiho Pharmaceutical Co., Ltd.
Conditions:
Stress Urinary Incontinence
Eligibility:
FEMALE
20+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of TAS-303 in female patients with stress urinary incontinence.
Detailed Description
The main purpose of this study is to assess the efficacy of TAS-303 in female patients with stress urinary incontinence (SUI) compared with placebo as measured by the percent change in the average SUI...
Eligibility Criteria
Inclusion
- Key
- Patient has symptoms of Stress Urinary Incontinence (SUI) for at least 12 weeks prior to study entry
- Urinary incontinence in the 1-hour pad weight test exceeds 2.0 g
- The average number of SUI episodes is 1 or more per day
- The average number of urge urinary incontinence (UUI) episodes is 0.43 or less per day
- The number of "SUI episodes" exceeds the number of "other episodes"
- The average number of urinary diurnal frequency is 10 or less per day and the average number of nocturia frequency is 2 or less per day
- Key
Exclusion
- Patient has been diagnosed with mixed urinary incontinence (MUI) that is predominantly UUI
- Patient has treated medication or therapy for SUI within 14 days before prior to study entry
- Patient is considered to have SUI that would not be expected to improve unless treated with surgical therapy
- Patient had a history of surgical treatment for urinary incontinence (Trans-obturator tape surgery, Tension-free vaginal tape surgery, etc.)
- Patient has stage II or more of Pelvic Organ Prolapse (POP), or had a history of POP repair surgery within 180 days before prior to study entry
- Patient has a serious illness or medical condition
Key Trial Info
Start Date :
September 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 22 2021
Estimated Enrollment :
231 Patients enrolled
Trial Details
Trial ID
NCT04512053
Start Date
September 4 2020
End Date
December 22 2021
Last Update
February 10 2022
Active Locations (4)
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1
A site selected by Taiho Pharmaceutical Co., Ltd.
Aichi, Japan
2
A site selected by Taiho Pharmaceutical Co., Ltd.
Fukuoka, Japan
3
A site selected by Taiho Pharmaceutical Co., Ltd.
Osaka, Japan
4
A site selected by Taiho Pharmaceutical Co., Ltd.
Tokyo, Japan