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临床试验/EUCTR2004-001243-30-CZ
EUCTR2004-001243-30-CZ进行中(未招募)不适用

Propiverine hydrochloride in children suffering from overactive bladder and urinary incontinence. A randomised, double-blind, placebo-controlled, parallel grouped multicentre clinical trial.

Apogepha Arzneimittel GmbH0 个研究点目标入组 490 人开始时间: 2004年11月4日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
490

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • - male and female Caucasian children aged 6 – 10 years
  • - suffering from overactive bladder
  • - who voluntarily signed informed consent and who have parental consent
  • - body weight between 17 – 45 kg
  • - micturition frequency of at least 8 micturitions / day
  • - incontinence episodes (at least 1 within 7 days)
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) no
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • - bladder capacity in ml equal/more than (age+1) x 30 ml
  • - post void residual urine > 10 ml
  • - treatment of overactive bladder in the past 28 days
  • - urinary tract infection
  • - enuresis nocturna
  • - dysfunctional voiding and detrusor-sphincter-dyssynergy

研究者

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