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

Genetic Disorder Clinical Trial

Official title:

Norditropin Treatment in Subjects With Noonan Syndrome. Effects on Linear Growth and Final Height - Data Collection and Follow-up Visit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01529840
• Other study ID #: GHNOO-1658
• Secondary ID: 2005-000042-37
• Status: Completed
• Phase: Phase 3
• First received: January 2, 2012
• Last updated: January 17, 2017
• Start date: June 1990
• Est. completion date: September 2005

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 2005
• Est. primary completion date: September 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Genetic Disorder
• Noonan Syndrome
• Syndrome

Intervention

Drug:
• somatropin
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
• somatropin
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

Locations

Country	Name	City	State
Sweden	Novo Nordisk Investigational Site	Göteborg

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Osio D, Dahlgren J, Wikland KA, Westphal O. Improved final height with long-term growth hormone treatment in Noonan syndrome. Acta Paediatr. 2005 Sep;94(9):1232-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in height SDS (Standard Deviation Score) from start of treatment to final height (referenced to normal population)
Secondary	Final height SDS
Secondary	Change in height SDS from start of treatment to final height (referenced to Noonan population)
Secondary	Height velocity
Secondary	Change in height velocity
Secondary	Sitting height
Secondary	Number and proportion of subjects with final height SDS above -2 SDS
Secondary	Adverse events

External Links

•   Clinical Trials at Novo Nordisk