EUCTR2017-003423-30-NL进行中（未招募）1 期
Randomized, double-blind, placebo-controlled oxytocin and dose-response trial in children with Prader-Willi syndrome.Effects on social behaviour.
Dutch Growth Research Foundation0 个研究点目标入组 33 人开始时间: 2017年10月4日最近更新:
适应症
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
- 33
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
- •In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- •- Genetically confirmed diagnosis of Prader-Willi syndrome
- •- Children aged 3 to 10.99 years
- •- Informed consent
- •- Currently on growth hormone treatment for at least 1 year
- •- Behavioural characteristics such as reduced social reciprocity and interaction, repetitive behaviour or temper tantrums, and/or be in nutritional phase 2b or 3 according to Miller (increased interest in food, hyperphagia)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 33
- •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
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •- Severe psychiatric problems
- •- Non-cooperative behaviour
- •- Allergic reactions or hypersensitivity for oxytocin
- •- Serious illness
- •- Cardiac abnormalities
- •- Extremely low dietary intake or less than required itnake acoording to WHO
- •- Medication to reduce weight (fat)
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