Back to resultsA Phase 2 Study of TAS-303 in Female Patients With Stress Urinary Incontinence
Primary Purpose
Stress Urinary Incontinence
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
TAS-303 18 mg/day
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring Urinary Incontinence, Urinary Incontinence, Stress, Lower Urinary Tract Symptoms
Eligibility Criteria
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
Sites / Locations
- A site selected by Taiho Pharmaceutical Co., Ltd.
- A site selected by Taiho Pharmaceutical Co., Ltd.
- A site selected by Taiho Pharmaceutical Co., Ltd.
- A site selected by Taiho Pharmaceutical Co., Ltd.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
TAS-303
Placebo
Arm Description
Outcomes
Primary Outcome Measures
The percent change in the average SUI episode frequency per 24 hours
Secondary Outcome Measures
The average urinary incontinence episode frequency per 24 hours
The urinary incontinence volume measured in a 24-hour pad test
The change in the international Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)
The change in the Patient's Global Impressions of Improvement (PGI I) questionnaire.
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.
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.
Incidence of adverse events and side effects
Full Information
NCT ID
NCT04512053
First Posted
August 7, 2020
Last Updated
February 8, 2022
Sponsor
Taiho Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04512053
Brief Title
A Phase 2 Study of TAS-303 in Female Patients With Stress Urinary Incontinence
Official Title
A Phase 2, Randomized, Placebo-controlled, Double-blind Study of TAS-303 in Female Patients With Stress Urinary Incontinence
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
September 4, 2020 (Actual)
Primary Completion Date
December 22, 2021 (Actual)
Study Completion Date
December 22, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taiho Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
Keywords
Urinary Incontinence, Urinary Incontinence, Stress, Lower Urinary Tract Symptoms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
231 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TAS-303
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
TAS-303 18 mg/day
Intervention Description
Oral administration for 12 weeks, once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral administration for 12 weeks, once daily
Primary Outcome Measure Information:
Title
The percent change in the average SUI episode frequency per 24 hours
Time Frame
Baseline, week 12
Secondary Outcome Measure Information:
Title
The average urinary incontinence episode frequency per 24 hours
Time Frame
Baseline, week 4, week 8, week 12
Title
The urinary incontinence volume measured in a 24-hour pad test
Time Frame
Baseline, week 12
Title
The change in the international Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)
Time Frame
Baseline, week 4, week 8, week 12
Title
The change in the Patient's Global Impressions of Improvement (PGI I) questionnaire.
Time Frame
Baseline, week 4, week 8, week 12
Title
The change in the incontinence quality of life instrument (I QOL) scores
Description
The minimum score is 22 points and the maximum is 110 points. The higher scores mean a worse outcome.
Time Frame
Baseline, week 4, week 8, week 12
Title
The changes in the overactive bladder symptom score (OABSS)
Description
The minimum score is 0 points and the maximum is 15 points. The higher scores mean a worse outcome.
Time Frame
Baseline, week 4, week 8, week 12
Title
Incidence of adverse events and side effects
Time Frame
Up to 13 Weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Taiho Pharmaceutical Co., Ltd.
Organizational Affiliation
Taiho Pharmaceutical Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
A site selected by Taiho Pharmaceutical Co., Ltd.
City
Aichi
Country
Japan
Facility Name
A site selected by Taiho Pharmaceutical Co., Ltd.
City
Fukuoka
Country
Japan
Facility Name
A site selected by Taiho Pharmaceutical Co., Ltd.
City
Osaka
Country
Japan
Facility Name
A site selected by Taiho Pharmaceutical Co., Ltd.
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
A Phase 2 Study of TAS-303 in Female Patients With Stress Urinary Incontinence
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