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

January 28, 2019 updated by: Taiho Pharmaceutical Co., Ltd.

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

The purpose of this study is to evaluate the efficacy and safety of TAS-303 in female patients with stress urinary incontinence.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

256

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Oral administration for 8 weeks, once daily.
Experimental: TAS-303 3mg
Drug: TAS-303
Oral administration for 8 weeks, once daily.
Experimental: TAS-303 6mg
Drug: TAS-303
Oral administration for 8 weeks, once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The percent change in incontinence episode frequency
Time Frame: Baseline, 8 weeks
Baseline, 8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
The change in the incontinence episode frequency
Time Frame: Baseline, 4 weeks, 8 weeks
Baseline, 4 weeks, 8 weeks
The change in the incontinence amount in 1-hour pad weight test
Time Frame: Baseline, 8 weeks
Baseline, 8 weeks
The change in the international Consultation on Incontinence Questionnaire-Short Form(ICIQ-SF)
Time Frame: Baseline, 4 weeks, 8 weeks
Baseline, 4 weeks, 8 weeks
The change in the Patient's Global Impressions of Improvement (PGI I) questionnaire.
Time Frame: Baseline, 4 weeks, 8 weeks
Baseline, 4 weeks, 8 weeks
The change in the incontinence quality of life instrument (I QOL) scores
Time Frame: Baseline and 4 and 8 weeks after the administration
Baseline and 4 and 8 weeks after the administration
Safety assessed by incidence and severity of adverse events
Time Frame: 12 Weeks
12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taiho Pharmaceutical Co., Ltd.

Investigators

  • Study Director: Taiho Pharmaceutical Co., Ltd, Taiho Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

April 30, 2018

Study Completion (Actual)

April 30, 2018

Study Registration Dates

First Submitted

September 8, 2016

First Submitted That Met QC Criteria

September 14, 2016

First Posted (Estimate)

September 20, 2016

Study Record Updates

Last Update Posted (Actual)

January 30, 2019

Last Update Submitted That Met QC Criteria

January 28, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10060050

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stress Urinary Incontinence

Clinical Trials on TAS-303

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Taiwan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe