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临床试验/JPRN-jRCT2080225307
JPRN-jRCT2080225307已完成2 期

A phase 2, randomized, placebo-controlled, double-blind study of TAS-303 in female patients with stress urinary incontinence

Taiho Pharmaceutical Co., Ltd.0 个研究点目标入组 186 人开始时间: 2020年8月11日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
186

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
>= 20age old 至 ot applicable(—)
性别
Female

入选标准

  • Key Inclusion Criteria:
  • -Patient has symptoms of Stress Urinary Incontinence (SUI) for at least 12 weeks prior to study entry
  • -Urinary incontinence in the 1-hour pad weight test exceeds 2.0 g
  • -The average number of SUI episodes is 1 or more per day
  • - The average number of urge urinary incontinence (UUI) episodes is 0.43 or less per day
  • -The number of SUI episodes exceeds the number of other episodes
  • -The average number of urinary diurnal frequency is 10 or less per day and the average number of nocturia frequency is 2 or less per day

排除标准

  • Key Exclusion Criteria:
  • - Patient has been diagnosed with mixed urinary incontinence (MUI) that is predominantly UUI
  • - Patient has treated medication or therapy for SUI within 14 days before prior to study entry
  • - Patient is considered to have SUI that would not be expected to improve unless treated with surgical therapy
  • - Patient had a history of surgical treatment for urinary incontinence (Trans-obturator tape surgery, Tension-free vaginal tape surgery, etc.)
  • - Patient has stage II or more of Pelvic Organ Prolapse (POP), or had a history of POP repair surgery within 180 days before prior to study entry
  • - Patient has a serious illness or medical condition

研究者

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