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A Study 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: NCT02562807
Recruitment Status : Completed
First Posted : September 29, 2015
Last Update Posted : August 10, 2016
Sponsor:
Information provided by (Responsible Party):
Taiho Pharmaceutical Co., Ltd.

Brief Summary:
The purpose of this study is to evaluate pharmacological effect, safety and pharmacokinetic of TAS-303 in female patients with Stress Urinary Incontinence.

Condition or disease Intervention/treatment Phase
Stress Urinary Incontinence Drug: TAS-303 18mg single-dose Drug: Placebo 18mg single-dose Drug: TAS-303 9mg single-dose Drug: Placebo 9mg single-dose Phase 1

Detailed Description:
This study is double-blind, placebo-controlled crossover study. The main purpose of this study is to evaluate Urethral Pressure Profile Parameters in Stress Urinary Incontinence patients who will receive single dose of TAS-303 or Placebo.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase I Study of TAS-303 in Female Patients With Stress Urinary Incontinence
Study Start Date : October 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Treatment A
TAS-303 18mg single-dose and then Placebo single-dose.
Drug: TAS-303 18mg single-dose
Drug: Placebo 18mg single-dose
Placebo Comparator: Treatment B
Placebo single-dose and then TAS-303 18mg single-dose.
Drug: TAS-303 18mg single-dose
Drug: Placebo 18mg single-dose
Active Comparator: Treatment C
TAS-303 9mg single-dose and then Placebo single-dose.
Drug: TAS-303 9mg single-dose
Drug: Placebo 9mg single-dose
Placebo Comparator: Treatment D
TAS-303 Placebo single-dose and then TAS-303 9mg single-dose.
Drug: TAS-303 9mg single-dose
Drug: Placebo 9mg single-dose



Primary Outcome Measures :
  1. Change from baseline in Maximum Urethral Closure Pressure (MUCP) [ Time Frame: Baseline, 6 hours after the administration ]

Secondary Outcome Measures :
  1. Urethral pressure profile parameters: mean urethral closure pressure, functional profile length [ Time Frame: Baseline, 6 hours after the administration ]
  2. Safety assessed by incidence and severity of adverse events [ Time Frame: Up to 36 days after the administration ]
  3. Maximum plasma concentration (Cmax) of TAS-303 [ Time Frame: 1, 2, 4, 6, 8, 12, 24, 48, 72 hours after the administration ]
  4. Time to maximum plasma concentration (tmax) of TAS-303 [ Time Frame: 1, 2, 4, 6, 8, 12, 24, 48, 72 hours after the administration ]
  5. Area under the plasma concentration versus time curve (AUC) of TAS-303 [ Time Frame: Immediately prior to dosing, and 1, 2, 4, 6, 8, 12, 24, 48, 72 hours after the administration ]
  6. Elimination half-time (t1/2) of TAS-303 [ Time Frame: 1, 2, 4, 6, 8, 12, 24, 48, 72 hours after the administration ]


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Ages Eligible for Study:   20 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Patient has symptoms of Stress Urinary Incontinence (SUI) for at least 12 weeks prior to study entry
  • Patient weights at least 45 kg and has body mass index (BMI) range of 18.0-30.0 kg/m2, inclusive, at screening
  • Patient is positive in 1-hour pad weight test at screening
  • Patient has at least 2 incontinence episodes per week.

Key Exclusion Criteria:

  • Patient has predominant or primary urge incontinence according to investigator judgment
  • Patient had a prior surgical SUI treatment
  • Patient is diagnosed Pelvic Organ Prolapse
  • Patient is currently taking medication, or has taken medication in the last 4 weeks, for urinary incontinence or that effect urinary output function including anti-cholinergic or anti-histamines or any anti-anxiety medications.
  • Patient is positive pregnancy test

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): NCT02562807


Locations
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Japan
Taiho Pharmaceutical Co., Ltd selected site
Kumamoto, 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: NCT02562807    
Other Study ID Numbers: 10060040
First Posted: September 29, 2015    Key Record Dates
Last Update Posted: August 10, 2016
Last Verified: August 2016
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
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders