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

Taiho Pharma

Status and phase: Completed; Phase 2

Conditions: Stress Urinary Incontinence

Treatments: Drug: Placebo; Drug: TAS-303 18 mg/day

Study type: Interventional

Funder types: Industry

Identifiers

NCT04512053

10060070

Details and patient eligibility

About

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

Full 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 episode frequency per 24 hours from baseline at week 12.

Enrollment: 231 patients

Sex: Female

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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

Key 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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231 participants in 2 patient groups, including a placebo group

TAS-303

Experimental group

Treatment:

Drug: TAS-303 18 mg/day

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo