NCT00795925已完成2 期
Dose-Escalating Study of Propiverine Hydrochloride (Mictonetten®) in Children Suffering From Frequency-Urgency-Syndrome and Urinary Incontinence Indicative of Detrusor Overactivity (Overactive Bladder)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Pharmacokinetic parameters of propiverine and its main metabolite propiverine N-oxide at steady state: Ctrough, Cmax, Tmax, AUC0-8h. Children were separated into 3 groups.
研究概览
简要总结
The open-label dose-escalating two-centre study was designed to assess the pharmacokinetics as well as safety, tolerability and efficacy parameters of propiverine in patients 5-10 years of age suffering from frequency-urgency-syndrome and urinary incontinence indicative of detrusor overactivity (overactive bladder) for determination of the recommended dose in children.
研究设计
- 研究类型
- Interventional
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Micturition Frequency ≥6 micturitions during awake period
- •Urge Incontinence Episodes ≥1/week
- •Urgency Episodes ≥1/day
排除标准
- •Contraindication to anticholinergic therapy
- •Repeated measurement of Post Void Residual ≥20 mL
- •Nocturnal Enuresis
- •Clinically significant cardiovascular, hepatic, renal, gastrointestinal or hematological disease, psychiatric disorder or diabetes insipidus
- •Anatomical abnormalities of the urinary tract
研究组 & 干预措施
propiverine hydrochloride
Experimental
干预措施: propiverine hydrochloride (Drug)
结局指标
主要结局
Pharmacokinetic parameters of propiverine and its main metabolite propiverine N-oxide at steady state: Ctrough, Cmax, Tmax, AUC0-8h. Children were separated into 3 groups.
次要结局
- Tolerability of propiverine. Efficacy: Changes from baseline: voiding frequency, incontinence and urgency episodes,voided volume. Safety: Post Void Residual (PVR),adverse events,laboratory values (urine, blood), ECG.(two weeks)
研究者
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