NCT02906683

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
337

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 20, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

October 20, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
6.4 years until next milestone

Results Posted

Study results publicly available

September 26, 2024

Completed
Last Updated

September 26, 2024

Status Verified

May 1, 2024

Enrollment Period

1.5 years

First QC Date

September 8, 2016

Results QC Date

August 24, 2023

Last Update Submit

May 27, 2024

Conditions

Stress Urinary Incontinence

Keywords

Urinary IncontinenceUrinary Incontinence, StressLower Urinary Tract Symptoms

Outcome Measures

Primary Outcomes (2)

  • Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 8

    Baseline to Week 8 (8 weeks in treatment period)

  • Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 8

    Baseline to Week 8 (8 weeks in treatment period)

Secondary Outcomes (13)

  • Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 4

    Baseline to Week 4 (4 weeks in treatment period)

  • Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 4

    Baseline to Week 4 (4 weeks in treatment period)

  • Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 4 in SUI Subgroup

    Baseline to Week 4 (4 weeks in treatment period)

  • Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 4 in SUI Subgroup

    Baseline to Week 4 (4 weeks in treatment period)

  • Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 8 in SUI Subgroup

    Baseline to Week 8 (8 weeks in treatment period)

  • +8 more secondary outcomes

Study Arms (3)

TAS-303 3mg

EXPERIMENTAL
Drug: TAS-303

TAS-303 6mg

EXPERIMENTAL
Drug: TAS-303

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

TAS-303DRUG

Oral administration for 8 weeks, once daily.

TAS-303 3mgTAS-303 6mg
PlaceboDRUG

Oral administration for 8 weeks, once daily.

Placebo

Eligibility Criteria

Age20 Years - 79 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (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
  • Patient has at least 1 incontinence episodes per day, and urinary diurnal frequency of 10 or less per day and nocturia of 2 or less per day.
  • Patient is positive in 1-hour pad weight test

You may not qualify if:

  • Patient has predominant or primary urge incontinence according to investigator judgment
  • Patient had a prior surgical SUI treatment
  • Patient is diagnosed stageII or more of Pelvic Organ Prolapse
  • Patient has symptoms of Urinary tract infection (UTI)
  • Patient is positive pregnancy test
  • Patient has on physical examination, neurological and/or vaginal examination results which, in the opinion of the investigator, should exclude the subject.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taiho Pharmaceutical Co., Ltd selected site

Osaka, Japan

Location

MeSH Terms

Conditions

Urinary Incontinence, StressUrinary IncontinenceLower Urinary Tract Symptoms

Interventions

TAS-303

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Taiho Pharmaceutical Co., Ltd.
Organization
Clinical Trial Registration Contact
toiawase@taiho.co.jp
+81-3-3293-2455

Study Officials

  • Taiho Pharmaceutical Co., Ltd

    Taiho Pharmaceutical Co., Ltd.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

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

September 8, 2016

First Posted

September 20, 2016

Study Start

October 20, 2016

Primary Completion

April 30, 2018

Study Completion

April 30, 2018

Last Updated

September 26, 2024

Results First Posted

September 26, 2024

Record last verified: 2024-05

Locations

JP(1)