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

A Phase 2, Randomized, Placebo-controlled, Double-blind 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: Stress Urinary Incontinence
• Intervention / Treatment: Drug: TAS-303 18 mg/day; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 231
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • 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, Japan
    • A site selected by Taiho Pharmaceutical Co., Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Placebo; Oral administration for 12 weeks, once daily
EXPERIMENTAL: TAS-303	Drug: TAS-303 18 mg/day; Oral administration for 12 weeks, once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The percent change in the average SUI episode frequency per 24 hours	Baseline, week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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
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
Incidence of adverse events and side effects		Up to 13 Weeks

Collaborators and Investigators

• Sponsor: Taiho Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 4, 2020
• Primary Completion (ACTUAL): December 22, 2021
• Study Completion (ACTUAL): December 22, 2021

Study Registration Dates

• First Submitted: August 7, 2020
• First Submitted That Met QC Criteria: August 11, 2020
• First Posted (ACTUAL): August 13, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2022
• Last Update Submitted That Met QC Criteria: February 8, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Lower Urinary Tract Symptoms; Urinary Incontinence, Stress; Urinary Incontinence
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: 10060070

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Taiho Group (Taiho) provides a platform for accepting researchers requests for sharing anonymized, patient-level, analyzable datasets from articles published in peer-reviewed journals about the primary results from Taiho-sponsored interventional clinical trials in patients in which the medicine and the indication has received marketing approval from regulatory authorities in the United States, the European Union, and/or Japan on or after January 15, 2018.

Access to the clinical trial data is contingent upon approval of a proposed study protocol by an independent review panel and the execution of a data-sharing agreement with the researcher.

See: https://www.taiho.co.jp/en/science/policy/clinical_trial_information_disclosure_policy/index.html

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No