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

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

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

Study Overview

• Status: Completed
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Drug: TAS-303 18mg single-dose; Drug: Placebo 18mg single-dose; Drug: TAS-303 9mg single-dose; Drug: Placebo 9mg single-dose

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 Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Kumamoto, Japan
    • Taiho Pharmaceutical Co., Ltd selected site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Key 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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment A; TAS-303 18mg single-dose and then Placebo single-dose.	Drug: TAS-303 18mg single-dose; Drug: Placebo 18mg single-dose
Placebo Comparator: Treatment B; Placebo single-dose and then TAS-303 18mg single-dose.	Drug: TAS-303 18mg single-dose; Drug: Placebo 18mg single-dose
Active Comparator: Treatment C; TAS-303 9mg single-dose and then Placebo single-dose.	Drug: TAS-303 9mg single-dose; Drug: Placebo 9mg single-dose
Placebo Comparator: Treatment D; TAS-303 Placebo single-dose and then TAS-303 9mg single-dose.	Drug: TAS-303 9mg single-dose; Drug: Placebo 9mg single-dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in Maximum Urethral Closure Pressure (MUCP)	Baseline, 6 hours after the administration

Secondary Outcome Measures

Outcome Measure	Time Frame
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
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
Elimination half-time (t1/2) of TAS-303	1, 2, 4, 6, 8, 12, 24, 48, 72 hours after the administration

Collaborators and Investigators

• Sponsor: Taiho Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: September 18, 2015
• First Submitted That Met QC Criteria: September 25, 2015
• First Posted (Estimate): September 29, 2015

Study Record Updates

• Last Update Posted (Estimate): August 10, 2016
• Last Update Submitted That Met QC Criteria: August 9, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Lower Urinary Tract Symptoms; Urinary Incontinence, Stress; Urinary Incontinence
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: 10060040