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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01529840
First received: January 2, 2012
Last updated: April 29, 2014
Last verified: April 2014

January 2, 2012
April 29, 2014
August 2005
September 2005   (final data collection date for primary outcome measure)
Change in height SDS (Standard Deviation Score) from start of treatment to final height (referenced to normal population) [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01529840 on ClinicalTrials.gov Archive Site
  • Final height SDS [ Designated as safety issue: No ]
  • Change in height SDS from start of treatment to final height (referenced to Noonan population) [ Designated as safety issue: No ]
  • Height velocity [ Designated as safety issue: No ]
  • Change in height velocity [ Designated as safety issue: No ]
  • Sitting height [ Designated as safety issue: No ]
  • Number and proportion of subjects with final height SDS above -2 SDS [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Somatropin Effect on Linear Growth and Final Height in Subjects With Noonan Syndrome
Norditropin Treatment in Subjects With Noonan Syndrome. Effects on Linear Growth and Final Height - Data Collection and Follow-up Visit

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.

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
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
  • Experimental: Low dose 33 mcg/kg/day
    Intervention: Drug: somatropin
  • Experimental: High dose 66 mcg/kg/day
    Intervention: Drug: somatropin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
September 2005
September 2005   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01529840
GHNOO-1658, 2005-000042-37
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
April 2014

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