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NCT01529944 Clinical Trial

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

Genetic Disorder Clinical Trial

Official title:
Genetic Testing of Noonan Subjects Previously Treated With Norditropin® in the GHNOO-1658 Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01529944
Other study ID # GHNOO-3680
Secondary ID 2008-004535-38
Status Completed
Phase Phase 3
First received
Last updated
Start date September 2008
Est. completion date October 2008

Study information
Verified date August 2023
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 22
Est. completion date October 2008
Est. primary completion date October 2008
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Participation in the GHNOO-1658 trial - Subject has completed genetic testing of PTPN11 mutation

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• somatropin
Results from a genetic testing for the PTPN11 mutation will be collected retrospectively for 24 subjects with Noonan syndrome previously treated with somatropin in accordance with the S/GHD/004/N00 protocol and in the follow-up trial GHNOO-1658.
• somatropin
Results from a genetic testing for the PTPN11 mutation will be collected retrospectively for 24 subjects with Noonan syndrome previously treated with somatropin in accordance with the S/GHD/004/N00 protocol and in the follow-up trial GHNOO-1658.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in height SDS (Standard Deviation Score) (referenced to normal population) From baseline until final height is reached
Secondary Final height SDS (referenced to normal population) From baseline until final height is reached
Secondary Final height SDS (referenced to Noonan population) From baseline until final height is reached
Secondary Change in height SDS (referenced to Noonan population) From baseline until final height is reached
Secondary Number of subjects with final height SDS above - 2SDS (reference to normal population) When final height is reached
Secondary Proportion of subjects with final height SDS above - 2SDS (reference to normal population) When final height is reached
Secondary Adverse events From baseline until final height is reached
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Completed NCT01529840 - Somatropin Effect on Linear Growth and Final Height in Subjects With Noonan Syndrome Phase 3
Completed NCT01710696 - Induction of Puberty With 17-beta Estradiol in Girls With Turner Syndrome Phase 3
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