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

Stress Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02906683
• Other study ID #: 10060050
• Status: Completed
• Phase: Phase 2
• Start date: October 1, 2016
• Est. completion date: April 30, 2018

Study information

• Verified date: January 2019
• Source: Taiho Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 256
• Est. completion date: April 30, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Drug:
• TAS-303
Oral administration for 8 weeks, once daily.
• Placebo
Oral administration for 8 weeks, once daily.

Locations

Country	Name	City	State
Japan	Taiho Pharmaceutical Co., Ltd selected site	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Taiho Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

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