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

Sponsor

Taiho Pharmaceutical Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT04512053

Collaborator

(none)

231

Enrollment

Locations

Arms

15.6

Actual Duration (Months)

57.8

Patients Per Site

3.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Stress Urinary Incontinence	Drug: TAS-303 18 mg/day Drug: Placebo	Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

231 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 4, 2020

Actual Primary Completion Date :

Dec 22, 2021

Actual Study Completion Date :

Dec 22, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TAS-303	Drug: TAS-303 18 mg/day Oral administration for 12 weeks, once daily
Placebo Comparator: Placebo	Drug: Placebo Oral administration for 12 weeks, once daily

Arm

Intervention/Treatment

Experimental: TAS-303

Drug: TAS-303 18 mg/day

Oral administration for 12 weeks, once daily

Placebo Comparator: Placebo

Drug: Placebo

Oral administration for 12 weeks, once daily

Outcome Measures

Primary Outcome Measures

The percent change in the average SUI episode frequency per 24 hours [Baseline, week 12]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country
1	A site selected by Taiho Pharmaceutical Co., Ltd.	Aichi	Japan
2	A site selected by Taiho Pharmaceutical Co., Ltd.	Fukuoka	Japan
3	A site selected by Taiho Pharmaceutical Co., Ltd.	Osaka	Japan
4	A site selected by Taiho Pharmaceutical Co., Ltd.	Tokyo	Japan