Clinical trial NCT02906683: Exploratory Trial of TAS-303 in Female Patients With Stress Urinary Incontinence
Official title: A Phase IIa Study of TAS-303 in Female Patients With Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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: 2016-09-20
Enrollment: 337
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of TAS-303 in female patients with stress urinary incontinence.

Detailed description: The main purpose of this study is to assess the efficacy of TAS-303 for 8 weeks in female patients with stress urinary incontinence (SUI) compared with placebo as measured by the percent change in incontinence episode frequency (IEF) from baseline.

Eligibility criteria: Inclusion Criteria:

* Patient has symptoms of Stress Urinary Incontinence (SUI) for at least 12 weeks prior to study entry
* Patient has at least 1 incontinence episodes per day, and urinary diurnal frequency of 10 or less per day and nocturia of 2 or less per day.
* Patient is positive in 1-hour pad weight test

Exclusion Criteria:

* Patient has predominant or primary urge incontinence according to investigator judgment
* Patient had a prior surgical SUI treatment
* Patient is diagnosed stageII or more of Pelvic Organ Prolapse
* Patient has symptoms of Urinary tract infection (UTI)
* Patient is positive pregnancy test
* Patient has on physical examination, neurological and/or vaginal examination results which, in the opinion of the investigator, should exclude the subject.

Primary outcomes:
measure: Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 8
timeFrame: Baseline to Week 8 (8 weeks in treatment period)
measure: Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 8
timeFrame: Baseline to Week 8 (8 weeks in treatment period)
Secondary outcomes:
measure: Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 4
timeFrame: Baseline to Week 4 (4 weeks in treatment period)
measure: Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 4
timeFrame: Baseline to Week 4 (4 weeks in treatment period)
measure: Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 4 in SUI Subgroup
timeFrame: Baseline to Week 4 (4 weeks in treatment period)
measure: Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 4 in SUI Subgroup
timeFrame: Baseline to Week 4 (4 weeks in treatment period)
measure: Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 8 in SUI Subgroup
timeFrame: Baseline to Week 8 (8 weeks in treatment period)
measure: Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 8 in SUI Subgroup
timeFrame: Baseline to Week 8 (8 weeks in treatment period)
measure: Percentages of the Patients With an Incontinence Amount of ≤ 2.0 g (Deemed Dryness) in the 1-hour Pad Test at Week 8 in the Treatment Period
timeFrame: At Week 8 in the treatment period
measure: Patient Global Impression-Improvement (PGI-I) Rates at Baseline, Week 4 and Week 8
timeFrame: Baseline to Week 8 (8 weeks in treatment period)
measure: Any Adverse Events
timeFrame: Baseline to Week 8 (8 weeks in treatment period)
measure: Advese Events Occurring in ≥2% of Patients in Any Treatment Group During the Treatment Period
timeFrame: Baseline to Week 8 (8 weeks in treatment period)
measure: Adverse Drug Reactions
timeFrame: Baseline to Week 8 (8 weeks in treatment period)
measure: Serious Adverse Events
timeFrame: Baseline to Week 8 (8 weeks in treatment period)
measure: Adverse Events Leading to Discontinuation of Administration
timeFrame: Baseline to Week 8 (8 weeks in treatment period)
Other outcomes:
Locations:
city: Osaka
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: