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

Phase 3

Completed

• Conditions: Genetic Disorder; Noonan Syndrome
• Interventions: Drug: somatropin

• Registration Number: NCT01529840
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1990-06
• Primary Completion: 2005-09
• Study Completion: 2005-09
• Study First Submitted: 2012-01-02
• Study First Submitted QC: 2012-02-08
• Study First Posted: 2012-02-09
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-17
• Last Update Posted: 2017-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low dose 33 mcg/kg/day	somatropin	-
High dose 66 mcg/kg/day	somatropin	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Sitting height
Change in height SDS from start of treatment to final height (referenced to Noonan population)
Final height SDS
Height velocity
Change in height velocity
Number and proportion of subjects with final height SDS above -2 SDS
Adverse events

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇸🇪 Göteborg, Sweden