Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00191113
Status:
COMPLETED
Last Update Posted:
2010-01-27
First Post:
2005-09-12
Brief Title:
Somatropin Treatment to Final Height in Turner Syndrome
Sponsor:
Eli Lilly and Company
Organization:
Eli Lilly and Company
Study Overview
Official Title:
Humatrope Treatment to Final Height in Turners Syndrome
Status:
COMPLETED
Status Verified Date:
2009-12
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:
GDCT
Brief Summary:
A randomized controlled trial in girls with Turner syndrome at least 7 years old and younger than 13 at study entry to determine the efficacy and safety of Humatrope somatropin treatment in promoting linear growth to final height
Detailed Description:
A randomized controlled trial of Humatrope somatropin treatment in girls with Turner syndrome at least 7 years old and younger than 13 at study entry
Core study objectives are to determine the efficacy of Humatrope in promoting linear growth to final height in girls with Turner syndrome and to assess the safety of this treatment Core study completion criteria protocol final height are that the patient has both a height velocity 2 cm per year and a bone age of 14 years or greater
Addendum 1 provides the option of Humatrope treatment to patients who were randomized to the Control arm of the Core study and who discontinued from the study on or after December 19 1997
Addendum 2 objectives are 1 to collect true final height data 2 to evaluate hearing tympanic membrane function and other specific areas of interest with respect to the safety of growth hormone therapy in Turner syndrome 3 to evaluate pancreatic beta cell function glucose metabolism in patients previously enrolled in the Core study
Addendum 3 objective is to determine the parental origin of the retained X chromosome of an appropriate subset of patients currently or previously enrolled in the Core study and to determine whether this parental origin holds any predictive value for spontaneous growth or for response to growth hormone therapy
Core study objectives are to determine the efficacy of Humatrope in promoting linear growth to final height in girls with Turner syndrome and to assess the safety of this treatment Core study completion criteria protocol final height are that the patient has both a height velocity 2 cm per year and a bone age of 14 years or greater
Addendum 1 provides the option of Humatrope treatment to patients who were randomized to the Control arm of the Core study and who discontinued from the study on or after December 19 1997
Addendum 2 objectives are 1 to collect true final height data 2 to evaluate hearing tympanic membrane function and other specific areas of interest with respect to the safety of growth hormone therapy in Turner syndrome 3 to evaluate pancreatic beta cell function glucose metabolism in patients previously enrolled in the Core study
Addendum 3 objective is to determine the parental origin of the retained X chromosome of an appropriate subset of patients currently or previously enrolled in the Core study and to determine whether this parental origin holds any predictive value for spontaneous growth or for response to growth hormone therapy
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 |
|---|---|---|---|
| 4419 GDCT1 Addenda | None | None | None |
| 817 B9R-CA-GDCT Core study | None | None | None |