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

NCT04512053 | Completed Phase 2

• 1 other identifier: 10060070
• Study Type: interventional
• Target: 231
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Stress Urinary Incontinence

Keywords

Urinary Incontinence; Urinary Incontinence, Stress; Lower Urinary Tract Symptoms

Outcome Measures

Primary Outcomes (1)

• The percent change in the average SUI episode frequency per 24 hours

  Baseline, week 12

Secondary Outcomes (7)

• 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

Study Arms (2)

TAS-303

EXPERIMENTAL

Drug: TAS-303 18 mg/day

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

TAS-303 18 mg/day DRUG

Oral administration for 12 weeks, once daily

TAS-303

Placebo DRUG

Oral administration for 12 weeks, once daily

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taiho Pharmaceutical Co., Ltd.: lead

Study Sites (4)

A site selected by Taiho Pharmaceutical Co., Ltd.

Aichi, Japan

Location

A site selected by Taiho Pharmaceutical Co., Ltd.

Fukuoka, Japan

Location

A site selected by Taiho Pharmaceutical Co., Ltd.

Osaka, Japan

Location

A site selected by Taiho Pharmaceutical Co., Ltd.

Tokyo, Japan

Location

Related Publications (1)

• Takahashi S, Kato K, Yokoyama O, Takei M, Gotoh M. Efficacy and Safety of TAS-303 in Female Patients With Stress Urinary Incontinence: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial. J Urol. 2024 Aug;212(2):267-279. doi: 10.1097/JU.0000000000004024. Epub 2024 Jul 9.

  PMID: 38979756 DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Stress; Urinary Incontinence; Lower Urinary Tract Symptoms

Interventions

TAS-303

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Taiho Pharmaceutical Co., Ltd.

  Taiho Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2020
• First Posted: August 13, 2020
• Study Start: September 4, 2020
• Primary Completion: December 22, 2021
• Study Completion: December 22, 2021
• Last Updated: February 10, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

JP (4)