NCT00603343已完成3 期
Treatment With Propiverine in Children Suffering From Non-Neurogenic Overactive Bladder and Urinary Incontinence: Results of a Randomized Placebo-Controlled Phase III Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 303
- 主要终点
- voiding frequency
研究概览
简要总结
The study was conducted between 2004 and 2006 to prove efficacy and tolerability of the antimuscarinic propiverine compared to placebo in children suffering from non-neurogenic overactive bladder and urinary incontinence.
详细描述
This clinical trial showed superior efficacy of propiverine over placebo and convincing tolerability for the treatment of children suffering from OAB and urinary incontinence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •voiding frequency 8 or above per day
- •at least one incontinence episode per day
- •age between 5-10 years
- •body weight between 17 and 45 kg
排除标准
- •normal age expected bladder capacity
- •PVR more than 10 ml
- •dysfunctional voiding
- •neurogenic disorders
- •UTI, constipation
研究组 & 干预措施
1
Active Comparator
干预措施: Mictonetten 5 mg, coated tablet (Drug)
2
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
voiding frequency
时间窗: before therapy and at end of therapy
次要结局
- voided volume(before and at end of treatment)
- incontinence episodes per day(before and at end of therapy)
- safety parameters: acute urinary retention, post void residual urine, urinalysis, ECG, blood pressure, pulse rate(before and at end of treatment)
研究者
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