NCT04676139Unknown3 期
The Safety and Efficacy of Selective Serotonin Reuptake Inhibitors, Fluoxetine, for Refractory Primary Mono-symptomatic Nocturnal Enuresis in Children: A Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- assess efficacy Selective Serotonin Reuptake Inhibitors, Fluoxetine, for refractory Primary Mono-symptomatic Nocturnal Enuresis in children.
研究概览
简要总结
To determine whether there is a role for the selective serotonin reuptake inhibitors, fluoxetine, as therapy in the treatment of refractory primary monosymptomatic nocturnal enuresis in children , and whether there are side effects involved.
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
- None
盲法说明
Open Label
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary Monosymptomatic nocturnal enuresis
- •Failed treatment with desmopressin.
- •The enuresis alarm had either been tried without effect, or deemed unfeasible because of the family situation.
- •All patients had either tried and failed combination therapy with anticholinergics or, because of contraindications, been unable to receive such therapy.
- •Severe enuresis with at least seven wet nights out of 14
排除标准
- •Underlying renal, urologic, neurologic, endocrinologic, or cardiac conditions
- •Depression
- •Severe psychiatric diseases
- •Untreated constipation
研究组 & 干预措施
Fluoxetine
Experimental
patients will undergo maintenance therapy selective serotonin reuptake inhibitors, fluoxetine, 10 mg capsules once daily for 12 weeks
干预措施: Fluoxetine (Drug)
Placebo
Placebo Comparator
patients will undergo maintenance therapy Placebo for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
assess efficacy Selective Serotonin Reuptake Inhibitors, Fluoxetine, for refractory Primary Mono-symptomatic Nocturnal Enuresis in children.
时间窗: 6 months
counting the wet nights numbers between baseline and after 2 weeks of each treatment period
次要结局
- assess the safety of Selective Serotonin Reuptake Inhibitors, Fluoxetine, for refractory Primary Mono-symptomatic Nocturnal Enuresis in children.(6 months)
研究者
研究点 (1)
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