NCT01575678Unknown2 期
The Effect of Melatonin on Nocturnal Enuresis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- number of incontinence episodes
研究概览
简要总结
Aim: To investigate the effect of melatonin in bedwetting.
详细描述
Design: Double blind randomized placebocontrolled trial using crossover.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Monosymptomatic nocturnal enuresis
- •Age 6-14 years
- •Clinical examination normal
- •≥ 3 wet nights / week due to either nocturnal polyuria with normal bladder size or reduced functional bladder capacity with normal urine output
排除标准
- •Constipation (by ROME III criteria)
- •Day incontinence
- •Overactive bladder (ICCS 2008 classification of symptoms)
- •Current or past history of clinical or laboratory findings that can be related to diseases or - conditions (eg pregnancy) likely to change the parameters examined, especially diseases of the kidney and urinary tract, liver or endocrine disorder.
- •Clinical signs of urinary tract infection
- •Hypertension, blood pressure assessed by ambulatory measurement with blood pressure cuff
- •Set treatment with one or more drugs
研究组 & 干预措施
Melatonin
Active Comparator
干预措施: Melatonin (Drug)
Lactose
Placebo Comparator
干预措施: Lactose (Drug)
结局指标
主要结局
number of incontinence episodes
时间窗: 10 weeks
次要结局
- nocturnal blood pressure(4 weeks)
- activity level(4 weeks)
- bladder capacity(4 weeks)
- nocturnal urine production(4 weeks)
研究者
研究点 (1)
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