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
Phase 1
- Conditions
- Prader-Willi SyndromeMedDRA version: 9.1Level: LLTClassification code 10036476Term: Prader-Willi syndrome
- Registration Number
- EUCTR2007-004716-31-NL
- Lead Sponsor
- Dutch Growth Foundation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method