Somatropin Effect on Linear Growth and Final Height in Subjects With Noonan Syndrome

Novo Nordisk A/S24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Genetic Disorder Noonan Syndrome

Interventions

somatropinDRUG

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

somatropinDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Novo Nordisk Investigational Site

Gothenburg, Sweden

Outcomes

Primary Outcomes

Change in height SDS (Standard Deviation Score) from start of treatment to final height (referenced to normal population)

Secondary Outcomes

Final height SDS

Change in height SDS from start of treatment to final height (referenced to Noonan population)

Height velocity

Change in height velocity

Sitting height

Number and proportion of subjects with final height SDS above -2 SDS

Adverse events

Data from ClinicalTrials.gov

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