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

Primary Purpose

Stress Urinary Incontinence

Status

Completed

Phase

Phase 2

Locations

Japan

Study Type

Interventional

Intervention

TAS-303

Placebo

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 - 79 Years (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

Taiho Pharmaceutical Co., Ltd selected site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

TAS-303 3mg

TAS-303 6mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

The percent change in incontinence episode frequency

Secondary Outcome Measures

The change in the incontinence episode frequency

The change in the incontinence amount in 1-hour pad weight test

The change in the international Consultation on Incontinence Questionnaire-Short Form(ICIQ-SF)

The change in the Patient's Global Impressions of Improvement (PGI I) questionnaire.

The change in the incontinence quality of life instrument (I QOL) scores

Safety assessed by incidence and severity of adverse events

Full Information

NCT ID

NCT02906683

First Posted

September 8, 2016

Last Updated

January 28, 2019

Sponsor

Taiho Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02906683

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

October 1, 2016 (Actual)

Primary Completion Date

April 30, 2018 (Actual)

Study Completion Date

April 30, 2018 (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 the efficacy and safety of TAS-303 in female patients with stress urinary incontinence.

Detailed 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.

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 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

256 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TAS-303 3mg

Arm Type

Experimental

Arm Title

TAS-303 6mg

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

TAS-303

Intervention Description

Oral administration for 8 weeks, once daily.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Oral administration for 8 weeks, once daily.

Primary Outcome Measure Information:

Title

The percent change in incontinence episode frequency

Time Frame

Baseline, 8 weeks

Secondary Outcome Measure Information:

Title

The change in the incontinence episode frequency

Time Frame

Baseline, 4 weeks, 8 weeks

Title

The change in the incontinence amount in 1-hour pad weight test

Time Frame

Baseline, 8 weeks

Title

The change in the international Consultation on Incontinence Questionnaire-Short Form(ICIQ-SF)

Time Frame

Baseline, 4 weeks, 8 weeks

Title

The change in the Patient's Global Impressions of Improvement (PGI I) questionnaire.

Time Frame

Baseline, 4 weeks, 8 weeks

Title

The change in the incontinence quality of life instrument (I QOL) scores

Time Frame

Baseline and 4 and 8 weeks after the administration

Title

Safety assessed by incidence and severity of adverse events

Time Frame

12 Weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

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

Osaka

Country

Japan

12. IPD Sharing Statement

Learn more about this trial

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

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