A Phase 2 Study of TAS-303 in Female Patients With Stress Urinary Incontinence

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

231 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-04

Study Completion Date

2021-12-22

Brief Summary

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The purpose of this study is to evaluate the efficacy and safety of TAS-303 in female patients with stress urinary incontinence.

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Detailed Description

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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 episode frequency per 24 hours from baseline at week 12.

Conditions

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Stress Urinary Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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TAS-303

Group Type EXPERIMENTAL

TAS-303 18 mg/day

Intervention Type DRUG

Oral administration for 12 weeks, once daily

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral administration for 12 weeks, once daily

Interventions

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TAS-303 18 mg/day

Oral administration for 12 weeks, once daily

Intervention Type DRUG

Placebo

Oral administration for 12 weeks, once daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No