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

Stress Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02562807
• Other study ID #: 10060040
• Status: Completed
• Phase: Phase 1
• First received: September 18, 2015
• Last updated: August 9, 2016
• Start date: October 2015
• Est. completion date: March 2016

Study information

• Verified date: August 2016
• Source: Taiho Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 64 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Drug:
• TAS-303 18mg single-dose

• Placebo 18mg single-dose

• TAS-303 9mg single-dose

• Placebo 9mg single-dose

Locations

Country	Name	City	State
Japan	Taiho Pharmaceutical Co., Ltd selected site	Kumamoto

Sponsors (1)

Lead Sponsor	Collaborator
Taiho Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Maximum Urethral Closure Pressure (MUCP)		Baseline, 6 hours after the administration	No
Secondary	Urethral pressure profile parameters: mean urethral closure pressure, functional profile length		Baseline, 6 hours after the administration	No
Secondary	Safety assessed by incidence and severity of adverse events		Up to 36 days after the administration	No
Secondary	Maximum plasma concentration (Cmax) of TAS-303		1, 2, 4, 6, 8, 12, 24, 48, 72 hours after the administration	No
Secondary	Time to maximum plasma concentration (tmax) of TAS-303		1, 2, 4, 6, 8, 12, 24, 48, 72 hours after the administration	No
Secondary	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	No
Secondary	Elimination half-time (t1/2) of TAS-303		1, 2, 4, 6, 8, 12, 24, 48, 72 hours after the administration	No