Genetic Testing of Noonan Subjects Previously Treated With Norditropin®. An Extension to Trial GHNOO-1658
2 other identifiers
interventional
22
1 country
1
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.
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 Sep 2008
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 2, 2012
CompletedFirst Posted
Study publicly available on registry
February 9, 2012
CompletedAugust 9, 2023
August 1, 2023
1 month
January 2, 2012
August 8, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Change in height SDS (Standard Deviation Score) (referenced to normal population)
From baseline until final height is reached
Secondary Outcomes (6)
Final height SDS (referenced to normal population)
From baseline until final height is reached
Final height SDS (referenced to Noonan population)
From baseline until final height is reached
Change in height SDS (referenced to Noonan population)
From baseline until final height is reached
Number of subjects with final height SDS above - 2SDS (reference to normal population)
When final height is reached
Proportion of subjects with final height SDS above - 2SDS (reference to normal population)
When final height is reached
- +1 more secondary outcomes
Study Arms (2)
Low dose 33 mcg/kg/day
EXPERIMENTALHigh dose 66 mcg/kg/day
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- Participation in the GHNOO-1658 trial
- Subject has completed genetic testing of PTPN11 mutation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (1)
Unknown Facility
Gothenburg, 416 85, Sweden
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
September 1, 2008
Primary Completion
October 1, 2008
Study Completion
October 1, 2008
Last Updated
August 9, 2023
Record last verified: 2023-08