A Phase 2 Study of TAS-303 in Female Patients With Stress Urinary Incontinence

Stress Urinary Incontinence Clinical Trial

Official title:

A Phase 2, Randomized, Placebo-controlled, Double-blind Study of TAS-303 in Female Patients With Stress Urinary Incontinence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04512053
• Other study ID #: 10060070
• Status: Completed
• Phase: Phase 2
• Start date: September 4, 2020
• Est. completion date: December 22, 2021

Study information

• Verified date: February 2022
• 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 in female patients with stress urinary incontinence (SUI) compared with placebo as measured by the percent change in the average SUI episode frequency per 24 hours from baseline at week 12.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 231
• Est. completion date: December 22, 2021
• Est. primary completion date: December 22, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

Key Inclusion Criteria:

• Patient has symptoms of Stress Urinary Incontinence (SUI) for at least 12 weeks prior to study entry
• Urinary incontinence in the 1-hour pad weight test exceeds 2.0 g
• The average number of SUI episodes is 1 or more per day
• The average number of urge urinary incontinence (UUI) episodes is 0.43 or less per day
• The number of "SUI episodes" exceeds the number of "other episodes"
• The average number of urinary diurnal frequency is 10 or less per day and the average number of nocturia frequency is 2 or less per day

Key Exclusion Criteria:

• Patient has been diagnosed with mixed urinary incontinence (MUI) that is predominantly UUI
• Patient has treated medication or therapy for SUI within 14 days before prior to study entry
• Patient is considered to have SUI that would not be expected to improve unless treated with surgical therapy
• Patient had a history of surgical treatment for urinary incontinence (Trans-obturator tape surgery, Tension-free vaginal tape surgery, etc.)
• Patient has stage II or more of Pelvic Organ Prolapse (POP), or had a history of POP repair surgery within 180 days before prior to study entry
• Patient has a serious illness or medical condition

Related Conditions & MeSH terms

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

Intervention

Drug:
• TAS-303 18 mg/day
Oral administration for 12 weeks, once daily
• Placebo
Oral administration for 12 weeks, once daily

Locations

Country	Name	City	State
Japan	A site selected by Taiho Pharmaceutical Co., Ltd.	Aichi
Japan	A site selected by Taiho Pharmaceutical Co., Ltd.	Fukuoka
Japan	A site selected by Taiho Pharmaceutical Co., Ltd.	Osaka
Japan	A site selected by Taiho Pharmaceutical Co., Ltd.	Tokyo

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 the average SUI episode frequency per 24 hours		Baseline, week 12
Secondary	The average urinary incontinence episode frequency per 24 hours		Baseline, week 4, week 8, week 12
Secondary	The urinary incontinence volume measured in a 24-hour pad test		Baseline, week 12
Secondary	The change in the international Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)		Baseline, week 4, week 8, week 12
Secondary	The change in the Patient's Global Impressions of Improvement (PGI I) questionnaire.		Baseline, week 4, week 8, week 12
Secondary	The change in the incontinence quality of life instrument (I QOL) scores	The minimum score is 22 points and the maximum is 110 points. The higher scores mean a worse outcome.	Baseline, week 4, week 8, week 12
Secondary	The changes in the overactive bladder symptom score (OABSS)	The minimum score is 0 points and the maximum is 15 points. The higher scores mean a worse outcome.	Baseline, week 4, week 8, week 12
Secondary	Incidence of adverse events and side effects		Up to 13 Weeks