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Completed

NCT Number: NCT02562807

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

The purpose of this study is to evaluate pharmacological effect, safety and pharmacokinetic of TAS-303 in female patients with Stress Urinary Incontinence.

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Key information

Conditions

Stress Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

20 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Taiho Pharmaceutical Co., Ltd selected site

Kumamoto, Japan

About this study

This study is double-blind, placebo-controlled crossover study. The main purpose of this study is to evaluate Urethral Pressure Profile Parameters in Stress Urinary Incontinence patients who will receive single dose of TAS-303 or Placebo.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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.

Key Exclusion Criteria:

  • 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

Treatment and study plan

TAS-303 18mg single-dose

Drug

Placebo 18mg single-dose

Drug

TAS-303 9mg single-dose

Drug

Placebo 9mg single-dose

Drug

Primary outcomes

  1. Change from baseline in Maximum Urethral Closure Pressure (MUCP)

    Time frame: Baseline, 6 hours after the administration

Secondary outcomes

  1. Urethral pressure profile parameters: mean urethral closure pressure, functional profile length

    Time frame: Baseline, 6 hours after the administration

  2. Safety assessed by incidence and severity of adverse events

    Time frame: Up to 36 days after the administration

  3. Maximum plasma concentration (Cmax) of TAS-303

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

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

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

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

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

  6. Elimination half-time (t1/2) of TAS-303

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

Sponsors and collaborators

Lead sponsor

Taiho Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Sep 29, 2015
Registry last updated
Aug 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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