Clinical trial NCT02562807: A Study of TAS-303 in Female Patients With Stress Urinary Incontinence
Official title: A Phase I Study of TAS-303 in Female Patients With Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Stress Urinary Incontinence
Keywords: Urinary Incontinence
Urinary Incontinence, Stress
Lower Urinary Tract Symptoms
Lead sponsor: Taiho Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-09-29
Enrollment: 16
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in Maximum Urethral Closure Pressure (MUCP)
timeFrame: Baseline, 6 hours after the administration
Secondary outcomes:
measure: Urethral pressure profile parameters: mean urethral closure pressure, functional profile length
timeFrame: Baseline, 6 hours after the administration
measure: Safety assessed by incidence and severity of adverse events
timeFrame: Up to 36 days after the administration
measure: Maximum plasma concentration (Cmax) of TAS-303
timeFrame: 1, 2, 4, 6, 8, 12, 24, 48, 72 hours after the administration
measure: Time to maximum plasma concentration (tmax) of TAS-303
timeFrame: 1, 2, 4, 6, 8, 12, 24, 48, 72 hours after the administration
measure: Area under the plasma concentration versus time curve (AUC) of TAS-303
timeFrame: Immediately prior to dosing, and 1, 2, 4, 6, 8, 12, 24, 48, 72 hours after the administration
measure: Elimination half-time (t1/2) of TAS-303
timeFrame: 1, 2, 4, 6, 8, 12, 24, 48, 72 hours after the administration
Other outcomes:
Locations:
city: Kumamoto
country: Japan
facility: Taiho Pharmaceutical Co., Ltd selected site
Study officials:
affiliation: Taiho Pharmaceutical Co., Ltd.
name: Taiho Pharmaceutical Co., Ltd.
role: STUDY_DIRECTOR
References: