NL-OMON43050撤回不适用
Intranasal administration of oxytocin in children with Prader-Willi Syndrome. A randomized, open-label, cross-over trial of different treatment regimens of oxytocin administration. Effects on eating behaviour and social behaviour. - Intranasal administration of oxytocin in children with PWS
Stichting Kind en Groei0 个研究点目标入组 44 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 44
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 17（—）
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
- •- Age between 3 and 16 years
- •- Currently on growth hormone treatment for at least 1 year
- •- Behavioural problems (for example temper tantrums and autistic behaviour) and/or be in nutritional phase 2b or 3 according to Miller.;For fMRI: age > 6 years
排除标准
- •- Severe psychiatric problems
- •- Non-cooperatieve behaviour
- •- Allergic reactions or hypersensitivity for oxytocin
- •- Serious illness
- •- Cardiac abnormalities
- •- Extremely low dietary intake or less than minimal required intake acoording to WHO
- •- Medication to reduce weight (fat)
研究者
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Intranasal administration of oxytocin in children with Prader-Willi Syndrome. A randomized, double-blind, placebo-controlled cross-over trial. Effects on satiety and food intake, and social behaviour.;Amendment: Six months open-label extension to the original studyPrader-Willi syndrome10083624NL-OMON41393Stichting Kind en Groei28
Unknown
不适用
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终止
4 期
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