Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00249821
Status:
COMPLETED
Last Update Posted:
2017-09-26
First Post:
2005-11-04
Brief Title:
Optimization of the Dosage Regimen of Growth Hormone Therapy in Children Born Small for Gestational Age
Sponsor:
Merck KGaA Darmstadt Germany
Organization:
Merck KGaA Darmstadt Germany
Study Overview
Official Title:
Optimization of the Dosage Regimen With Growth Hormone Therapy in Children Born Small for Gestational Age An Open Label Randomized Pilot Study Comparing in Children Treated for 3 Years the Efficacy of a Saizen Treatment at the Same Dose Versus a Lower Maintenance Dose Prolonged During 1 Additional Year
Status:
COMPLETED
Status Verified Date:
2017-08
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:
SGA OPTIMIS
Brief Summary:
Multicentric open-label randomized pilot comparative study in parallel groups comparing 1 group of subjects receiving 0057 milligramkilogramday mgkgday or 040 mgkgweek of Saizen during 1 year to 1 group receiving 0035 mgkgday 024 mgkgweek of Saizen during 1 year after an initial 3-year treatment of recombinant human growth hormone r-hGH therapy with 0057 mgkgday in both groups
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