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Register:	EUCTR
Last refreshed on:	22 May 2017
Main ID:	EUCTR2007-004716-31-NL
Date of registration:	06/11/2007
Prospective Registration:	Yes
Primary sponsor:	Dutch Growth Foundation
Public title:	Effects of growth hormone treatment after final height in Prader-Willi Syndrome: A double-blind multicenter, cross-over study on the effects of growth hormone versus placebo on body composition and psychosocial behaviour in transition - Effects of GH after final height in PWS
Scientific title:	Effects of growth hormone treatment after final height in Prader-Willi Syndrome: A double-blind multicenter, cross-over study on the effects of growth hormone versus placebo on body composition and psychosocial behaviour in transition - Effects of GH after final height in PWS
Date of first enrolment:	05/03/2008
Target sample size:
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-004716-31
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: yes Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no
Phase:	Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment
Netherlands

Contacts

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Key inclusion & exclusion criteria

Inclusion criteria:
-Genetically confirmed diagnosis of PWS and
-treated with GH during childhood for at least 2 years and
-final height is reached or epiphysial fusion is complete and
-aged 18-24
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
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

Exclusion criteria:
-non cooperative behaviour
-extremely low dietary intake of less than minimal required intake according to WHO
-medication to reduce weight (fat)

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Prader-Willi Syndrome
MedDRA version: 9.1 Level: LLT Classification code 10036476 Term: Prader-Willi syndrome

Intervention(s)

Trade Name: Genotropin
Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Primary end point(s): The aim of this double-blind cross-over, placebo-controlled study is to evaluate effects of GH-treatment versus withdrawal of GH, after final height is reached, on weight, body composition (as measured with DXA), psychosocial functioning (as measured with GIT, behavioural questionnaires), carbohydrate metabolism (as measured with OGTT), circulating lipids (total cholesterol, HDL, LDL, Lipoprotein A, TG), and sleep-related breathing (polysomnography) during transition period until the age of 24 years.

Main Objective: To assess effects of GH-treatment versus placebo in young adults with Prader-Willi Syndrome after reaching final height on
- body composition
- carbohydrate metabolism
- psychosocial functioning
- sleep-related breathing disorders
- circulating lipids
- blood pressure

Secondary Objective: - To study the effects of GH-treatment versus placebo in young adults with Prader-Willi Syndrome after reaching final height on thyroid hormone levels, IGF-I and IGF binding proteins, adiponectin, ghrelin.
- To study compliance to the diet.

Secondary Outcome(s)

Secondary ID(s)

GR8009

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
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