EUCTR2004-001243-30-NL进行中（未招募）1 期
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
- 1 期
- 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
- •- Female and male, Caucasian children aged: 5-10 years
- •- Signed informed consent and parental consent
- •- Body weight of 17-45 kg
- •- Micturition frequency >= 8/day at least in 1 of 3 diary days
- •- 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] >= (age+1)x30 [ml]
- •- Post void residual urine > 10 ml
- •- Treatment of overactive bladder symptoms in the last 28 days
- •- Urinary tract infection at the time of study inclusion or other acute and parasitic infections of the genitourinary tract
- •- Enuresis nocturna
- •- Dysfunctional voiding and detrusor-sphincter-dyssynergy
- •- Constipation
- •- Forbidden concomitant medication
- •- Clinical relevant disease of the kidneys, liver, gastrointestinal tract, cardiovascular system, metabolism
- •- Congenital anomalies of the genitourinary tract
- •- Inability of the subject's legally authorised representative or the patient to communicate with the investigator
研究者
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