NL-OMON30181尚未招募3 期
Propiverine hydrochloride in children suffering from overactive bladder and urinary incontinence. A randomised, double-blind, placebo-controlled, parallel grouped multicentre clinical trial - Propiverine-HCL in children suffering from OAB and urinary incontinence.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 8
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
- 2 至 11（—）
入选标准
- •Male or female, caucasian children: 5 to 10.
- •Body weight of 17-45 kg
- •Micturation frequency >= 8/day at least in 1 of 3 bladder diary days.
- •Incontinence episodes (at least 1 within 7 days)
排除标准
- •Bladder capacity [ml] >= ((age +1) x 30) [ml]
- •Post void residual > 10 ml
- •Treatment of overactive bladder symptoms in the last 28 days
- •Urinary tract infection at the time of study inclusion and other acute and parasitic infections of the genitourinary tract
- •Enuresis nocturna
- •Dysfunctional voiding and detrusor-sphincter-dyssynergy
- •Constipation
- •Forbidden concomitant medication (see chapter 9.4.7 of the protocol)
- •Clinical relevant disease of the kidney, liver, gastro-intestinal tract, cardiovascular system metabolism disorder (e.g. juvenile diabetes mellitus, diabetes insipidus
研究者
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