NCT02562807

Brief Summary

The purpose of this study is to evaluate pharmacological effect, safety and pharmacokinetic 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
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2015

Shorter than P25 for phase_1

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 18, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 29, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

August 10, 2016

Status Verified

August 1, 2016

Enrollment Period

2 months

First QC Date

September 18, 2015

Last Update Submit

August 9, 2016

Conditions

Stress Urinary Incontinence

Keywords

Urinary IncontinenceUrinary Incontinence, StressLower Urinary Tract Symptoms

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in Maximum Urethral Closure Pressure (MUCP)

    Baseline, 6 hours after the administration

Secondary Outcomes (6)

  • Urethral pressure profile parameters: mean urethral closure pressure, functional profile length

    Baseline, 6 hours after the administration

  • Safety assessed by incidence and severity of adverse events

    Up to 36 days after the administration

  • Maximum plasma concentration (Cmax) of TAS-303

    1, 2, 4, 6, 8, 12, 24, 48, 72 hours after the administration

  • Time to maximum plasma concentration (tmax) of TAS-303

    1, 2, 4, 6, 8, 12, 24, 48, 72 hours after the administration

  • Area under the plasma concentration versus time curve (AUC) of TAS-303

    Immediately prior to dosing, and 1, 2, 4, 6, 8, 12, 24, 48, 72 hours after the administration

  • +1 more secondary outcomes

Study Arms (4)

Treatment A

ACTIVE COMPARATOR

TAS-303 18mg single-dose and then Placebo single-dose.

Drug: TAS-303 18mg single-doseDrug: Placebo 18mg single-dose

Treatment B

PLACEBO COMPARATOR

Placebo single-dose and then TAS-303 18mg single-dose.

Drug: TAS-303 18mg single-doseDrug: Placebo 18mg single-dose

Treatment C

ACTIVE COMPARATOR

TAS-303 9mg single-dose and then Placebo single-dose.

Drug: TAS-303 9mg single-doseDrug: Placebo 9mg single-dose

Treatment D

PLACEBO COMPARATOR

TAS-303 Placebo single-dose and then TAS-303 9mg single-dose.

Drug: TAS-303 9mg single-doseDrug: Placebo 9mg single-dose

Interventions

TAS-303 18mg single-doseDRUG
Treatment ATreatment B
Placebo 18mg single-doseDRUG
Treatment ATreatment B
TAS-303 9mg single-doseDRUG
Treatment CTreatment D
Placebo 9mg single-doseDRUG
Treatment CTreatment D

Eligibility Criteria

Age20 Years - 64 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patient has symptoms of Stress Urinary Incontinence (SUI) for at least 12 weeks prior to study entry
  • Patient weights at least 45 kg and has body mass index (BMI) range of 18.0-30.0 kg/m2, inclusive, at screening
  • Patient is positive in 1-hour pad weight test at screening
  • Patient has at least 2 incontinence episodes per week.

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 Pelvic Organ Prolapse
  • Patient is currently taking medication, or has taken medication in the last 4 weeks, for urinary incontinence or that effect urinary output function including anti-cholinergic or anti-histamines or any anti-anxiety medications.
  • Patient is positive pregnancy test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taiho Pharmaceutical Co., Ltd selected site

Kumamoto, 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

Study Officials

  • Taiho Pharmaceutical Co., Ltd.

    Taiho Pharmaceutical Co., Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2015

First Posted

September 29, 2015

Study Start

October 1, 2015

Primary Completion

December 1, 2015

Study Completion

March 1, 2016

Last Updated

August 10, 2016

Record last verified: 2016-08

Locations

JP(1)