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

Taiho Pharma

Status and phase: Completed; Phase 1

Conditions: Stress Urinary Incontinence

Treatments: Drug: TAS-303 18mg single-dose; Drug: Placebo 18mg single-dose; Drug: Placebo 9mg single-dose; Drug: TAS-303 9mg single-dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT02562807

10060040

Details and patient eligibility

About

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

Full 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.

Enrollment: 16 patients

Sex: Female

Ages: 20 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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16 participants in 4 patient groups, including a placebo group

Treatment A

Active Comparator group

Description:

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

Treatment:

Drug: TAS-303 18mg single-dose

Drug: Placebo 18mg single-dose

Treatment B

Placebo Comparator group

Description:

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

Treatment:

Drug: TAS-303 18mg single-dose

Drug: Placebo 18mg single-dose

Treatment C

Active Comparator group

Description:

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

Treatment:

Drug: TAS-303 9mg single-dose

Drug: Placebo 9mg single-dose

Treatment D

Placebo Comparator group

Description:

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

Treatment:

Drug: TAS-303 9mg single-dose

Drug: Placebo 9mg single-dose