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

Phase 1

Completed

• Conditions: Stress Urinary Incontinence
• Interventions: Drug: TAS-303 18mg single-dose; Drug: TAS-303 9mg single-dose; Drug: Placebo 18mg single-dose; Drug: Placebo 9mg single-dose

• Registration Number: NCT02562807
• Lead Sponsor: Taiho Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2015-09-18
• Study First Submitted QC: 2015-09-25
• Study First Posted: 2015-09-29
• Study Start: 2015-10
• Primary Completion: 2015-12
• Study Completion: 2016-03
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-09
• Last Update Posted: 2016-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 16

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.

Key

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment A	TAS-303 18mg single-dose	TAS-303 18mg single-dose and then Placebo single-dose.
Treatment A	Placebo 18mg single-dose	TAS-303 18mg single-dose and then Placebo single-dose.
Treatment B	TAS-303 18mg single-dose	Placebo single-dose and then TAS-303 18mg single-dose.
Treatment B	Placebo 18mg single-dose	Placebo single-dose and then TAS-303 18mg single-dose.
Treatment C	TAS-303 9mg single-dose	TAS-303 9mg single-dose and then Placebo single-dose.
Treatment C	Placebo 9mg single-dose	TAS-303 9mg single-dose and then Placebo single-dose.
Treatment D	TAS-303 9mg single-dose	TAS-303 Placebo single-dose and then TAS-303 9mg single-dose.
Treatment D	Placebo 9mg single-dose	TAS-303 Placebo single-dose and then TAS-303 9mg single-dose.

Primary Outcome Measures

Name	Time	Method
Change from baseline in Maximum Urethral Closure Pressure (MUCP)	Baseline, 6 hours after the administration

Secondary Outcome Measures

Name	Time	Method
Time to maximum plasma concentration (tmax) of TAS-303	1, 2, 4, 6, 8, 12, 24, 48, 72 hours after the administration
Area under the plasma concentration versus time curve (AUC) of TAS-303	Immediately prior to dosing, and 1, 2, 4, 6, 8, 12, 24, 48, 72 hours after the administration
Urethral pressure profile parameters: mean urethral closure pressure, functional profile length	Baseline, 6 hours after the administration
Safety assessed by incidence and severity of adverse events	Up to 36 days after the administration
Maximum plasma concentration (Cmax) of TAS-303	1, 2, 4, 6, 8, 12, 24, 48, 72 hours after the administration
Elimination half-time (t1/2) of TAS-303	1, 2, 4, 6, 8, 12, 24, 48, 72 hours after the administration

Trial Locations

Locations (1)

Taiho Pharmaceutical Co., Ltd selected site; 🇯🇵 Kumamoto, Japan