A 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

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-03-31

Brief Summary

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The purpose of this study is to evaluate pharmacological effect, safety and pharmacokinetic of TAS-303 in female patients with Stress Urinary Incontinence.

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Detailed Description

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This study is double-blind, placebo-controlled crossover study. The main purpose of this study is to evaluate Urethral Pressure Profile Parameters in Stress Urinary Incontinence patients who will receive single dose of TAS-303 or Placebo.

Conditions

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Stress Urinary Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Treatment A

TAS-303 18mg single-dose and then Placebo single-dose.

Group Type ACTIVE_COMPARATOR

TAS-303 18mg single-dose

Intervention Type DRUG

Placebo 18mg single-dose

Intervention Type DRUG

Treatment B

Placebo single-dose and then TAS-303 18mg single-dose.

Group Type PLACEBO_COMPARATOR

TAS-303 18mg single-dose

Intervention Type DRUG

Placebo 18mg single-dose

Intervention Type DRUG

Treatment C

TAS-303 9mg single-dose and then Placebo single-dose.

Group Type ACTIVE_COMPARATOR

TAS-303 9mg single-dose

Intervention Type DRUG

Placebo 9mg single-dose

Intervention Type DRUG

Treatment D

TAS-303 Placebo single-dose and then TAS-303 9mg single-dose.

Group Type PLACEBO_COMPARATOR

TAS-303 9mg single-dose

Intervention Type DRUG

Placebo 9mg single-dose

Intervention Type DRUG

Interventions

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TAS-303 18mg single-dose

Intervention Type DRUG

Placebo 18mg single-dose

Intervention Type DRUG

TAS-303 9mg single-dose

Intervention Type DRUG

Placebo 9mg single-dose

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
* Patient weights at least 45 kg and has body mass index (BMI) range of 18.0-30.0 kg/m2, inclusive, at screening
* Patient is positive in 1-hour pad weight test at screening
* Patient has at least 2 incontinence episodes per week.

Exclusion Criteria

* Patient has predominant or primary urge incontinence according to investigator judgment
* Patient had a prior surgical SUI treatment
* Patient is diagnosed Pelvic Organ Prolapse
* Patient is currently taking medication, or has taken medication in the last 4 weeks, for urinary incontinence or that effect urinary output function including anti-cholinergic or anti-histamines or any anti-anxiety medications.
* Patient is positive pregnancy test

Minimum Eligible Age

20 Years

Maximum Eligible Age

64 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No