Exploratory Trial of TAS-303 in Female Patients With Stress Urinary Incontinence

Phase 2

Completed

• Conditions: Stress Urinary Incontinence
• Interventions: Drug: Placebo; Drug: TAS-303

• Registration Number: NCT02906683
• Lead Sponsor: Taiho Pharmaceutical Co., Ltd.

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.

Study Timeline

• Study First Submitted: 2016-09-08
• Study First Submitted QC: 2016-09-14
• Study First Posted: 2016-09-20
• Study Start: 2016-10-01
• Primary Completion: 2018-04-30
• Study Completion: 2018-04-30
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-28
• Last Update Posted: 2019-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 256

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
TAS-303 3mg	TAS-303	-
TAS-303 6mg	TAS-303	-

Primary Outcome Measures

Name	Time	Method
Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 8	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	Baseline to Week 8 (8 weeks in treatment period)

Secondary Outcome Measures

Name	Time	Method
Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 4	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	Baseline to Week 4 (4 weeks in treatment period)
Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 4 in SUI Subgroup	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	Baseline to Week 4 (4 weeks in treatment period)
Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 8 in SUI Subgroup	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	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	At Week 8 in the treatment period
Patient Global Impression-Improvement (PGI-I) Rates at Baseline, Week 4 and Week 8	Baseline to Week 8 (8 weeks in treatment period)	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".
Any Adverse Events	Baseline to Week 8 (8 weeks in 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.
Advese Events Occurring in ≥2% of Patients in Any Treatment Group During the Treatment Period	Baseline to Week 8 (8 weeks in 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.
Adverse Drug Reactions	Baseline to Week 8 (8 weeks in 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.
Serious Adverse Events	Baseline to Week 8 (8 weeks in treatment period)
Adverse Events Leading to Discontinuation of Administration	Baseline to Week 8 (8 weeks in treatment period)

Trial Locations

Locations (1)

Taiho Pharmaceutical Co., Ltd selected site; 🇯🇵 Osaka, Japan