EUCTR2004-001243-30-AT进行中（未招募）不适用
Propiverine hydrochloride in children suffering from overactive bladder and urinary incontinenceA randomised, double-blind, placebo-controlled, parallel grouped, multicentre clinical trial
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
- 200
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
- •-caucasian
- •-aged 5-10 years
- •-signed informed consent and parental consent
- •-body weight 17-45kg
- •>= 8 micturitions per day at least in 1 of 3 days
- •>= 1 incontinence episode in 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 [ml] >= 30(age+1)
- •-> 10ml post void residual urine
- •-treatment of overactive bladder symptoms in the last 28 days
- •-Urinary Tract Infection and other acute and parasitic infections of the genitourinary tract
- •-enuresis nocturna
- •-dysfunctional voiding and detrusor-sphincter-dyssynergy
- •-constipation
- •-clinical relevant diseases of the kidneys, liver, gastrointestinal tract, cardiovascular system, metabolism
- •-congenital anomalies of the genitourinary tract
- •-pre-existing medical contraindications for anticholinergics
- •-inability of the subject's legally authorised representative or the patient to communicate with the investigator
研究者
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