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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.

Detailed Summary:
Sponsor: Novo Nordisk A/S

Current Primary Outcome: Change in height SDS (Standard Deviation Score) from start of treatment to final height (referenced to normal population)

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Final height SDS
  • Change in height SDS from start of treatment to final height (referenced to Noonan population)
  • Height velocity
  • Change in height velocity
  • Sitting height
  • Number and proportion of subjects with final height SDS above -2 SDS
  • Adverse events


Original Secondary Outcome: Same as current

Information By: Novo Nordisk A/S

Dates:
Date Received: January 2, 2012
Date Started: June 1990
Date Completion:
Last Updated: January 17, 2017
Last Verified: January 2017