Genetic Testing of Noonan Subjects Previously Treated With Norditropin®. An Extension to Trial GHNOO-1658

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Genetic Disorder; Noonan Syndrome

Treatments: Drug: somatropin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01529944

GHNOO-3680

2008-004535-38 (EudraCT Number)

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this trial is to obtain the PTPN11 mutation status and investigate the impact of the PTPN11 mutation status on the effect of somatropin (Norditropin®) by use of data obtained in the GHNOO-1658 trial.

Enrollment: 22 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Participation in the GHNOO-1658 trial
• Subject has completed genetic testing of PTPN11 mutation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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22 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