Genetic Disorder, Noonan Syndrome
Conditions
Brief summary
This trial is conducted in Europe. The aim of this trial is to evaluate the effect of somatropin (Norditropin®) on final height in children with Noonan syndrome having being treated for up to 10 years with somatropin (Norditropin®) for the attainment of an optimal final height in the original trial S/GHD/004/NOO.
Interventions
DRUGsomatropin
Retrospective data collection based on data obtained from a prospective, open-label, randomised, parallel-group trial (S/GHD/004/NOO) combined with a present follow-up visit
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participation in the original S/GHD/004/NOO trial or following the protocol for S/GHD/004/NOO without being randomised in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in height SDS (Standard Deviation Score) from start of treatment to final height (referenced to normal population) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in height SDS from start of treatment to final height (referenced to Noonan population) | — |
| Height velocity | — |
| Change in height velocity | — |
| Final height SDS | — |
| Number and proportion of subjects with final height SDS above -2 SDS | — |
| Adverse events | — |
| Sitting height | — |
Countries
Sweden
Outcome results
None listed