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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date  ICMJE September 8, 2016
First Posted Date  ICMJE September 20, 2016
Last Update Posted Date January 30, 2019
Actual Study Start Date  ICMJE October 1, 2016
Actual Primary Completion Date April 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2016)
The percent change in incontinence episode frequency [ Time Frame: Baseline, 8 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2016)
  • The change in the incontinence episode frequency [ Time Frame: Baseline, 4 weeks, 8 weeks ]
  • The change in the incontinence amount in 1-hour pad weight test [ Time Frame: Baseline, 8 weeks ]
  • The change in the international Consultation on Incontinence Questionnaire-Short Form(ICIQ-SF) [ Time Frame: Baseline, 4 weeks, 8 weeks ]
  • The change in the Patient's Global Impressions of Improvement (PGI I) questionnaire. [ Time Frame: Baseline, 4 weeks, 8 weeks ]
  • The change in the incontinence quality of life instrument (I QOL) scores [ Time Frame: Baseline and 4 and 8 weeks after the administration ]
  • Safety assessed by incidence and severity of adverse events [ Time Frame: 12 Weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exploratory Trial of TAS-303 in Female Patients With Stress Urinary Incontinence
Official Title  ICMJE A Phase IIa Study of TAS-303 in Female Patients With Stress Urinary Incontinence
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Stress Urinary Incontinence
Intervention  ICMJE
  • Drug: TAS-303
    Oral administration for 8 weeks, once daily.
  • Drug: Placebo
    Oral administration for 8 weeks, once daily.
Study Arms  ICMJE
  • Experimental: TAS-303 3mg
    Intervention: Drug: TAS-303
  • Experimental: TAS-303 6mg
    Intervention: Drug: TAS-303
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 28, 2019)
256
Original Estimated Enrollment  ICMJE
 (submitted: September 14, 2016)
250
Actual Study Completion Date  ICMJE April 30, 2018
Actual Primary Completion Date April 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02906683
Other Study ID Numbers  ICMJE 10060050
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Taiho Pharmaceutical Co., Ltd.
Study Sponsor  ICMJE Taiho Pharmaceutical Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Taiho Pharmaceutical Co., Ltd Taiho Pharmaceutical Co., Ltd.
PRS Account Taiho Pharmaceutical Co., Ltd.
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP