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
2 other identifiers
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jun 1990
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 1990
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
January 2, 2012
CompletedFirst Posted
Study publicly available on registry
February 9, 2012
CompletedJanuary 18, 2017
January 1, 2017
15.3 years
January 2, 2012
January 17, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Change in height SDS (Standard Deviation Score) from start of treatment to final height (referenced to normal population)
Secondary Outcomes (7)
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
- +2 more secondary outcomes
Study Arms (2)
Low dose 33 mcg/kg/day
EXPERIMENTALHigh dose 66 mcg/kg/day
EXPERIMENTALInterventions
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
Eligibility Criteria
You may qualify if:
- Participation in the original S/GHD/004/NOO trial or following the protocol for S/GHD/004/NOO without being randomised in the trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (1)
Novo Nordisk Investigational Site
Gothenburg, 416 85, Sweden
Related Publications (1)
Osio D, Dahlgren J, Wikland KA, Westphal O. Improved final height with long-term growth hormone treatment in Noonan syndrome. Acta Paediatr. 2005 Sep;94(9):1232-7. doi: 10.1111/j.1651-2227.2005.tb02081.x.
PMID: 16203673RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 2, 2012
First Posted
February 9, 2012
Study Start
June 1, 1990
Primary Completion
September 1, 2005
Study Completion
September 1, 2005
Last Updated
January 18, 2017
Record last verified: 2017-01