The purpose of this study is to evaluate the efficacy and safety of TAS-303 in female patients with stress urinary incontinence.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
337
Taiho Pharmaceutical Co., Ltd selected site
Osaka, Japan
Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 8
Time frame: Baseline to Week 8 (8 weeks in treatment period)
Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 8
Time frame: Baseline to Week 8 (8 weeks in treatment period)
Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 4
Time frame: Baseline to Week 4 (4 weeks in treatment period)
Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 4
Time frame: Baseline to Week 4 (4 weeks in treatment period)
Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 4 in SUI Subgroup
Time frame: Baseline to Week 4 (4 weeks in treatment period)
Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 4 in SUI Subgroup
Time frame: Baseline to Week 4 (4 weeks in treatment period)
Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 8 in SUI Subgroup
Time frame: Baseline to Week 8 (8 weeks in treatment period)
Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 8 in SUI Subgroup
Time frame: Baseline to Week 8 (8 weeks in treatment period)
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
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Time frame: At Week 8 in the treatment period
Patient Global Impression-Improvement (PGI-I) Rates at Baseline, Week 4 and Week 8
PGI-I was used to evaluate the patients' impression of improvement of urinary incontinence. The improvement of PGI-I was defined as the selection of "Very much better", "Much better", or "A little better". The investigator or subinvestigator instructed patients to evaluate the improvement of urinary incontinence at the evaluation time point using the following 7-point scale: (1) "Very much better"; (2) "Much better"; (3) "A little better"; (4) "No change"; (5) "A little worse"; (6) "Much worse"; and (7) "Very much worse".
Time frame: Baseline to Week 8 (8 weeks in treatment period)
Any Adverse Events
For tabulation of adverse events, the terms of diagnosis recorded in the eCRFs were converted according to the Medical Dictionary for Regulatory Activities (MedDRA) ver. 20.1 and were expressed as preferred terms of MedDRA.
Time frame: Baseline to Week 8 (8 weeks in treatment period)
Advese Events Occurring in ≥2% of Patients in Any Treatment Group During the Treatment Period
For tabulation of adverse events, the terms of diagnosis recorded in the eCRFs were converted according to the Medical Dictionary for Regulatory Activities (MedDRA) ver. 20.1 and were expressed as preferred terms of MedDRA.
Time frame: Baseline to Week 8 (8 weeks in treatment period)
Adverse Drug Reactions
For tabulation of adverse events, the terms of diagnosis recorded in the eCRFs were converted according to the Medical Dictionary for Regulatory Activities (MedDRA) ver. 20.1 and were expressed as preferred terms of MedDRA.
Time frame: Baseline to Week 8 (8 weeks in treatment period)
Serious Adverse Events
Time frame: Baseline to Week 8 (8 weeks in treatment period)
Adverse Events Leading to Discontinuation of Administration
Time frame: Baseline to Week 8 (8 weeks in treatment period)