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

Primary Purpose

Stress Urinary Incontinence

Status

Completed

Phase

Phase 1

Locations

Japan

Study Type

Interventional

Intervention

TAS-303 18mg single-dose

Placebo 18mg single-dose

TAS-303 9mg single-dose

Placebo 9mg single-dose

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring Urinary Incontinence, Urinary Incontinence, Stress, Lower Urinary Tract Symptoms

Eligibility Criteria

20 Years - 64 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Taiho Pharmaceutical Co., Ltd selected site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

Treatment A

Treatment B

Treatment C

Treatment D

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Change from baseline in Maximum Urethral Closure Pressure (MUCP)

Secondary Outcome Measures

Urethral pressure profile parameters: mean urethral closure pressure, functional profile length

Safety assessed by incidence and severity of adverse events

Maximum plasma concentration (Cmax) of TAS-303

Time to maximum plasma concentration (tmax) of TAS-303

Area under the plasma concentration versus time curve (AUC) of TAS-303

Elimination half-time (t1/2) of TAS-303

Full Information

NCT ID

NCT02562807

First Posted

September 18, 2015

Last Updated

August 9, 2016

Sponsor

Taiho Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02562807

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Completed

Study Start Date

October 2015 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Taiho Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stress Urinary Incontinence

Keywords

Urinary Incontinence, Urinary Incontinence, Stress, Lower Urinary Tract Symptoms

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment A

Arm Type

Active Comparator

Arm Description

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

Arm Title

Treatment B

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Treatment C

Arm Type

Active Comparator

Arm Description

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

Arm Title

Treatment D

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

TAS-303 18mg single-dose

Intervention Type

Drug

Intervention Name(s)

Placebo 18mg single-dose

Intervention Type

Drug

Intervention Name(s)

TAS-303 9mg single-dose

Intervention Type

Drug

Intervention Name(s)

Placebo 9mg single-dose

Primary Outcome Measure Information:

Title

Change from baseline in Maximum Urethral Closure Pressure (MUCP)

Time Frame

Baseline, 6 hours after the administration

Secondary Outcome Measure Information:

Title

Urethral pressure profile parameters: mean urethral closure pressure, functional profile length

Time Frame

Baseline, 6 hours after the administration

Title

Safety assessed by incidence and severity of adverse events

Time Frame

Up to 36 days after the administration

Title

Maximum plasma concentration (Cmax) of TAS-303

Time Frame

1, 2, 4, 6, 8, 12, 24, 48, 72 hours after the administration

Title

Time to maximum plasma concentration (tmax) of TAS-303

Time Frame

1, 2, 4, 6, 8, 12, 24, 48, 72 hours after the administration

Title

Area under the plasma concentration versus time curve (AUC) of TAS-303

Time Frame

Immediately prior to dosing, and 1, 2, 4, 6, 8, 12, 24, 48, 72 hours after the administration

Title

Elimination half-time (t1/2) of TAS-303

Time Frame

1, 2, 4, 6, 8, 12, 24, 48, 72 hours after the administration

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Taiho Pharmaceutical Co., Ltd.

Organizational Affiliation

Taiho Pharmaceutical Co., Ltd.

Official's Role

Study Director

Facility Information:

Facility Name

Taiho Pharmaceutical Co., Ltd selected site

City

Kumamoto

Country

Japan

12. IPD Sharing Statement

Learn more about this trial

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

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