Exploratory Trial of TAS-303 in Female Patients With Stress Urinary Incontinence

Taiho Pharma

Status and phase: Completed; Phase 2

Conditions: Stress Urinary Incontinence

Treatments: Drug: TAS-303; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02906683

10060050

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 for 8 weeks in female patients with stress urinary incontinence (SUI) compared with placebo as measured by the percent change in incontinence episode frequency (IEF) from baseline.

Enrollment: 337 patients

Sex: Female

Ages: 20 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient has symptoms of Stress Urinary Incontinence (SUI) for at least 12 weeks prior to study entry
• Patient has at least 1 incontinence episodes per day, and urinary diurnal frequency of 10 or less per day and nocturia of 2 or less per day.
• Patient is positive in 1-hour pad weight test

Exclusion criteria

• Patient has predominant or primary urge incontinence according to investigator judgment
• Patient had a prior surgical SUI treatment
• Patient is diagnosed stageII or more of Pelvic Organ Prolapse
• Patient has symptoms of Urinary tract infection (UTI)
• Patient is positive pregnancy test
• Patient has on physical examination, neurological and/or vaginal examination results which, in the opinion of the investigator, should exclude the subject.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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337 participants in 3 patient groups, including a placebo group

TAS-303 3mg

Experimental group

Treatment:

Drug: TAS-303

TAS-303 6mg

Experimental group

Treatment:

Drug: TAS-303

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo