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

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Genetic Disorder; Noonan Syndrome

Treatments: Drug: somatropin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01529840

GHNOO-1658

2005-000042-37 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Low dose 33 mcg/kg/day

Experimental group

Treatment:

Drug: somatropin

Drug: somatropin

High dose 66 mcg/kg/day

Experimental group

Treatment:

Drug: somatropin

Drug: somatropin