Ignite Creation Date:
2024-05-05 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00490191
Status:
COMPLETED
Last Update Posted:
2007-06-22
First Post:
2007-06-20
Brief Title:
Comparison of Two Growth Hormone Dosing Methods in Adults With Growth Hormone Deficiency
Sponsor:
Eli Lilly and Company
Organization:
Eli Lilly and Company
Study Overview
Official Title:
Comparison of an Incremental Weight-Based Dose Regimen With an Individualized Dosage Adjusted According to the IGF-I Response in Adults With Growth Hormone Deficiency
Status:
COMPLETED
Status Verified Date:
2007-06
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 tested whether a dose regimen of growth hormone based on body weight is equivalent or better than starting with a low dose and gradually increasing the dose according to individual patient needs Efficacy of the two regimens were assessed from changes in body fat measured by dual-energy x-ray absorptiometry DXA scanning performed at the beginning of the study and at the completion of the study eight months later
Detailed Description:
Dose regimen of growth hormone based on weight Starting dose was 40 microgramskgday for four months then increased to 8 microgramskgday for two months and then increased to 12 microgramskgday for a further two months eight months in total
Dose regimen of growth hormone based on individual patient needs Starting dose was 200 microgramsday then increased by 200 microgramsday every two months for an additional six months eight months in total as needed for optimal treatment results
Dose regimen of growth hormone based on individual patient needs Starting dose was 200 microgramsday then increased by 200 microgramsday every two months for an additional six months eight months in total as needed for optimal treatment results
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-EW-T002 | None | None | None |