Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00396097
Status:
COMPLETED
Last Update Posted:
2016-04-05
First Post:
2006-11-02
Brief Title:
Individualized Target-Driven Treatment Of Children With Idiopathic Short Stature
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A Four Year Open Label Multi Center Randomized Two Arm Study Of Genotropin In Idiopathic Short Stature Patients Comparing An Individualized Target Driven Treatment Regimen To Standard Dosing Of Genotropin
Status:
COMPLETED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To demonstrate that an individualized formula-based Genotropin regimen for children with Idiopathic Short Stature will lead to a targeted height gain to reach the target of 10th percentile or -13 SDS during 24 months of treatment The endpoint at 4 years is to explore treatment efficiency over four years of two formula-based dose regimens sub-arms compared to standard treatment
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None