EUCTR2016-003273-18-FR进行中（未招募）1 期
Effects of intranasal administrations of oxytocin on beahvioural troubles, hyperphagia and social skills in children with Prader-Willi syndrome aged from 3 to 12 years. - OXYJEUNE
niversity Hospital of Toulouse0 个研究点目标入组 40 人开始时间: 2016年8月22日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •patient with a complete genetic diagnosis of PWS
- •patient aged from 3 to 12 years
- •patient treated by growth hormone for at least 1 year
- •patient naïve for OXT for at least 5 years
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 40
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •patient who do not accept intranasal administrations (major behavioural trouble)
- •patient with hepatic insufficiency : serum transaminases higher than 3 times normal values for age
- •patient with renal insufficiency : serum creatinine higher than 3 times normal values for age
- •patient with an antecedent of abnormal electrocardiogram
- •patient with arterial hypertension or hypotension
- •patient with type 1 or 2 diabetes
研究者
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