Clinical Trial: Genetic Testing of Noonan Subjects Previously Treated With Norditropin®. An Extension to Trial GHNOO-1658
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Genetic Testing of Noonan Subjects Previously Treated With Norditropin® in the GHNOO-1658 Trial
Brief 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.
Detailed Summary:
Sponsor: Novo Nordisk A/S
Current Primary Outcome: Change in height SDS (Standard Deviation Score) (referenced to normal population) [ Time Frame: From baseline until final height is reached ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Final height SDS (referenced to normal population) [ Time Frame: From baseline until final height is reached ]
- Final height SDS (referenced to Noonan population) [ Time Frame: From baseline until final height is reached ]
- Change in height SDS (referenced to Noonan population) [ Time Frame: From baseline until final height is reached ]
- Number of subjects with final height SDS above - 2SDS (reference to normal population) [ Time Frame: When final height is reached ]
- Proportion of subjects with final height SDS above - 2SDS (reference to normal population) [ Time Frame: When final height is reached ]
- Adverse events [ Time Frame: From baseline until final height is reached ]
Original Secondary Outcome: Same as current
Information By: Novo Nordisk A/S
Dates:
Date Received: January 2, 2012
Date Started: September 2008
Date Completion:
Last Updated: April 29, 2014
Last Verified: April 2014
