Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00191074
Status:
COMPLETED
Last Update Posted:
2007-03-09
First Post:
2005-09-12
Brief Title:
Amendment g Unblinded Extension Phase of Somatropin in Patients With Idiopathic Short Stature
Sponsor:
Eli Lilly and Company
Organization:
Eli Lilly and Company
Study Overview
Official Title:
Phase III Study of Humatrope in Non-Growth Hormone Deficient Children With Short Stature
Status:
COMPLETED
Status Verified Date:
2007-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
After approval of amendment g patients who were still receiving study drug at the time were scheduled for a study visit In addition patients who had discontinued early from the core blinded phase of the study were contacted
All of these patients were offered the opportunity to enter the unblinded extension phase if they met eligibility criteria and continue somatropin treatment regardless of initial treatment randomization until they reached final height
All of these patients were offered the opportunity to enter the unblinded extension phase if they met eligibility criteria and continue somatropin treatment regardless of initial treatment randomization until they reached final height
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 |
|---|---|---|---|
| B9R-MC-GDCH | None | None | None |