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

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ClinicalTrials.gov Identifier: NCT02906683
Recruitment Status : Completed
First Posted : September 20, 2016
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Stress Urinary Incontinence Drug: TAS-303 Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 256 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase IIa Study of TAS-303 in Female Patients With Stress Urinary Incontinence
Actual Study Start Date : October 1, 2016
Actual Primary Completion Date : April 30, 2018
Actual Study Completion Date : April 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TAS-303 3mg Drug: TAS-303
Oral administration for 8 weeks, once daily.

Experimental: TAS-303 6mg Drug: TAS-303
Oral administration for 8 weeks, once daily.

Placebo Comparator: Placebo Drug: Placebo
Oral administration for 8 weeks, once daily.




Primary Outcome Measures :
  1. The percent change in incontinence episode frequency [ Time Frame: Baseline, 8 weeks ]

Secondary Outcome Measures :
  1. The change in the incontinence episode frequency [ Time Frame: Baseline, 4 weeks, 8 weeks ]
  2. The change in the incontinence amount in 1-hour pad weight test [ Time Frame: Baseline, 8 weeks ]
  3. The change in the international Consultation on Incontinence Questionnaire-Short Form(ICIQ-SF) [ Time Frame: Baseline, 4 weeks, 8 weeks ]
  4. The change in the Patient's Global Impressions of Improvement (PGI I) questionnaire. [ Time Frame: Baseline, 4 weeks, 8 weeks ]
  5. The change in the incontinence quality of life instrument (I QOL) scores [ Time Frame: Baseline and 4 and 8 weeks after the administration ]
  6. Safety assessed by incidence and severity of adverse events [ Time Frame: 12 Weeks ]


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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02906683


Locations
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Japan
Taiho Pharmaceutical Co., Ltd selected site
Osaka, Japan
Sponsors and Collaborators
Taiho Pharmaceutical Co., Ltd.
Investigators
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Study Director: Taiho Pharmaceutical Co., Ltd Taiho Pharmaceutical Co., Ltd.
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Responsible Party: Taiho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02906683    
Other Study ID Numbers: 10060050
First Posted: September 20, 2016    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019
Keywords provided by Taiho Pharmaceutical Co., Ltd.:
Urinary Incontinence
Urinary Incontinence, Stress
Lower Urinary Tract Symptoms
Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders