Back to resultsSomatropin Effect on Linear Growth and Final Height in Subjects With Noonan Syndrome
Primary Purpose
Genetic Disorder, Noonan Syndrome
Status
Completed
Phase
Phase 3
Locations
Sweden
Study Type
Interventional
Intervention
somatropin
somatropin
Sponsored by
About this trial
This is an interventional treatment trial for Genetic Disorder
Eligibility Criteria
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
Sites / Locations
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Low dose 33 mcg/kg/day
High dose 66 mcg/kg/day
Arm Description
Outcomes
Primary Outcome Measures
Change in height SDS (Standard Deviation Score) from start of treatment to final height (referenced to normal population)
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01529840
Brief Title
Somatropin Effect on Linear Growth and Final Height in Subjects With Noonan Syndrome
Official Title
Norditropin Treatment in Subjects With Noonan Syndrome. Effects on Linear Growth and Final Height - Data Collection and Follow-up Visit
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
June 1990 (undefined)
Primary Completion Date
September 2005 (Actual)
Study Completion Date
September 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genetic Disorder, Noonan Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low dose 33 mcg/kg/day
Arm Type
Experimental
Arm Title
High dose 66 mcg/kg/day
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
somatropin
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
somatropin
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in height SDS (Standard Deviation Score) from start of treatment to final height (referenced to normal population)
Secondary Outcome Measure Information:
Title
Final height SDS
Title
Change in height SDS from start of treatment to final height (referenced to Noonan population)
Title
Height velocity
Title
Change in height velocity
Title
Sitting height
Title
Number and proportion of subjects with final height SDS above -2 SDS
Title
Adverse events
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Göteborg
ZIP/Postal Code
416 85
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
16203673
Citation
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.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Somatropin Effect on Linear Growth and Final Height in Subjects With Noonan Syndrome
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