Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00184717
Status:
COMPLETED
Last Update Posted:
2017-07-07
First Post:
2005-09-13
Brief Title:
Growth Hormone Treatment in Children Born Small for Gestational Age SGA
Sponsor:
Novo Nordisk AS
Organization:
Novo Nordisk AS
Study Overview
Official Title:
GHLIQUID-1516 A 104-week Multi-centre Randomised Double-blind Parallel-group no Treatment Controlled Open-label Trial Investigating the Efficacy and Safety of Two Doses of NN-220 in Subjects With Short Stature Born Small for Gestational Age GHLIQUID-1517 A Long-term Multi-centre Randomised Controlled Double-blind Parallel-group Trial Investigating the Efficacy and Safety of Two Doses of NN-220 in Subjects With Short Stature Born Small for Gestational Age
Status:
COMPLETED
Status Verified Date:
2017-06
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:
This study is conducted in Japan The aim of this trial is to assess the efficacy and safety of somatropin in children born small for gestational age SGA in Japan
In the main period subjects will receive either active treatment for 104 weeks two dosing regimens or no treatment for 52 weeks followed by an extension period where subjects who received active treatment for 104 weeks two years will continue with the same treatment for further 156 weeks three years while those subjects who received no treatment for 52 weeks one year will be randomised to receive two dosing regimens for 208 weeks four years In total subjects participate in trial for 260 weeks five years
Main period is registered internally at Novo Nordisk as GHLIQUID-1516 while the extension period is registered as GHLIQUID-1517
In the main period subjects will receive either active treatment for 104 weeks two dosing regimens or no treatment for 52 weeks followed by an extension period where subjects who received active treatment for 104 weeks two years will continue with the same treatment for further 156 weeks three years while those subjects who received no treatment for 52 weeks one year will be randomised to receive two dosing regimens for 208 weeks four years In total subjects participate in trial for 260 weeks five years
Main period is registered internally at Novo Nordisk as GHLIQUID-1516 while the extension period is registered as GHLIQUID-1517
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2017-000914-47 | REGISTRY | EudraCT | None |
| JapicCTI-050137 | REGISTRY | None | None |
| JapicCTI-050132 | REGISTRY | None | None |