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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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22 August 2016 |
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Main ID: |
NCT02562807 |
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Date of registration:
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18/09/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study of TAS-303 in Female Patients With Stress Urinary Incontinence
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Scientific title:
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A Phase I Study of TAS-303 in Female Patients With Stress Urinary Incontinence |
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Date of first enrolment:
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October 2015 |
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Target sample size:
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16 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02562807 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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Japan
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Contacts
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Name:
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Taiho Pharmaceutical Co., Ltd. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Taiho Pharmaceutical Co., Ltd. |
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Key inclusion & exclusion criteria
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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
Age minimum:
20 Years
Age maximum:
64 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Stress Urinary Incontinence
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Intervention(s)
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Drug: TAS-303 18mg single-dose
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Drug: Placebo 9mg single-dose
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Drug: TAS-303 9mg single-dose
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Drug: Placebo 18mg single-dose
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Primary Outcome(s)
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Change from baseline in Maximum Urethral Closure Pressure (MUCP)
[Time Frame: Baseline, 6 hours after the administration]
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Secondary Outcome(s)
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Urethral pressure profile parameters: mean urethral closure pressure, functional profile length
[Time Frame: Baseline, 6 hours after the administration]
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Maximum plasma concentration (Cmax) of TAS-303
[Time Frame: 1, 2, 4, 6, 8, 12, 24, 48, 72 hours after the administration]
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Safety assessed by incidence and severity of adverse events
[Time Frame: Up to 36 days after the administration]
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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]
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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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Time to maximum plasma concentration (tmax) of TAS-303
[Time Frame: 1, 2, 4, 6, 8, 12, 24, 48, 72 hours after the administration]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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