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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01529944
First received: January 2, 2012
Last updated: July 10, 2012
Last verified: July 2012
History of Changes

January 2, 2012
July 10, 2012
September 2008
October 2008   (final data collection date for primary outcome measure)
Change in height SDS (Standard Deviation Score) (referenced to normal population) [ Time Frame: From baseline until final height is reached ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01529944 on ClinicalTrials.gov Archive Site
  • Final height SDS (referenced to normal population) [ Time Frame: From baseline until final height is reached ] [ Designated as safety issue: No ]
  • Final height SDS (referenced to Noonan population) [ Time Frame: From baseline until final height is reached ] [ Designated as safety issue: No ]
  • Change in height SDS (referenced to Noonan population) [ Time Frame: From baseline until final height is reached ] [ Designated as safety issue: No ]
  • Number of subjects with final height SDS above - 2SDS (reference to normal population) [ Time Frame: When final height is reached ] [ Designated as safety issue: No ]
  • Proportion of subjects with final height SDS above - 2SDS (reference to normal population) [ Time Frame: When final height is reached ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: From baseline until final height is reached ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Genetic Testing of Noonan Subjects Previously Treated With Norditropin®. An Extension to Trial GHNOO-1658
Genetic Testing of Noonan Subjects Previously Treated With Norditropin® in the GHNOO-1658 Trial

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Genetic Disorder
  • Noonan Syndrome
Other: No treatment given
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.
  • No Intervention: Low dose 33 mcg/kg/day
    Intervention: Other: No treatment given
  • No Intervention: High dose 66 mcg/kg/day
    Intervention: Other: No treatment given
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
October 2008
October 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Participation in the GHNOO-1658 trial
  • Subject has completed genetic testing of PTPN11 mutation
Not Provided
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01529944
GHNOO-3680, 2008-004535-38
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk
Not Provided
Study Director: Lene Finnerup Nielsen Novo Nordisk
Novo Nordisk
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP