EUCTR2016-003820-22-NL进行中（未招募）1 期
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
Dutch Growth Research Foundation0 个研究点开始时间: 2016年10月12日最近更新:
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试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- •- 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
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 44
- •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
- •- 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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撤回
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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.NL-OMON43050Stichting Kind en Groei44
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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
Intranasal administration of oxytocin in PWSGenetically confirmed diagnosis of Prader-Willi syndromeNL-OMON21542Dutch Growth Research FoundationWestzeedijk 106, 3016 AH RotterdamTel: 010-2251533info@kindengroei.nl28
进行中（未招募）
1 期
Intranasal administration of oxytocin in children and young-adults with Prader-Willi syndromePrader-Willi syndromeMedDRA version: 17.0Level: PTClassification code 10036476Term: Prader-Willi syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2013-004134-15-NLDutch Growth Research Foundation
终止
4 期
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