Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00448747
Status:
COMPLETED
Last Update Posted:
2019-07-23
First Post:
2007-03-16
Brief Title:
Investigation of a New Oral Growth Hormone Secretagogue AEZS-130 as a Growth Hormone Stimulation Test
Sponsor:
AEterna Zentaris
Organization:
AEterna Zentaris
Study Overview
Official Title:
A Multi-center Study Investigating a New Oral Growth Hormone Secretagogue GHSAEZS 130 Formerly Ardana ARD-07 as a Growth Hormone GH Stimulation Test in Terms of Safety and Efficacy
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:
The diagnosis of growth hormone deficiency GHD in adults is established by laboratory testing in patients with an appropriate clinical history of hypothalamic pituitary disease Two tests that are considered to be gold standard tests for the diagnosis of GHD are the insulin tolerance test ITT and growth hormone releasing hormone GHRH combined with L-arginine L-ARG However these tests are either bothersome given intravenously to the patient or are linked with side effects Therefore an orally available compound like AEZS-130 formerly ARD-07 if demonstrated to be safe and providing adequate sensitivity and specificity could be a welcome alternative andor complement to the current available tests
The intent was to recruit 40 adult GHD AGHD patients and 40 healthy control subjects into this trial but the original sponsor Ardana Biosciences Ltd discontinued the study for financial reasons before this was completed At the time of withdrawal of GHRH from the market in 2008 42 AGHD patients and 10 normal controls had completed the study at 9 US sites This study reactivated to complete the remaining 30 matched control subjects
Additionally upon agreement with the FDA in a Special Protocol Assessment SPA 10 additional adult growth hormone deficient and their matched control were planned to be enrolled into this trial for a total treated population of approximatively 100 subjects
The intent was to recruit 40 adult GHD AGHD patients and 40 healthy control subjects into this trial but the original sponsor Ardana Biosciences Ltd discontinued the study for financial reasons before this was completed At the time of withdrawal of GHRH from the market in 2008 42 AGHD patients and 10 normal controls had completed the study at 9 US sites This study reactivated to complete the remaining 30 matched control subjects
Additionally upon agreement with the FDA in a Special Protocol Assessment SPA 10 additional adult growth hormone deficient and their matched control were planned to be enrolled into this trial for a total treated population of approximatively 100 subjects
Detailed Description:
Thirty control subjects ie without AGHD were matched to the 30 AGHD patients who were not previously matched Matching was based upon gender age BMI and estrogen status for females They received one oral dose of AEZS-130 followed by serial blood draws for growth hormone GH insulin-like growth factor 1 IGF-1 and pharmacokinetic PK determinations There was no cross over due to the unavailability of GHRH Geref in the United States Under Amendment 4 to this protocol 10 additional AGHD subjects were to be enrolled and matched as described above
Furthermore the objective of the study was changed to delete comparison with L-ARG GHRH
Furthermore the objective of the study was changed to delete comparison with L-ARG GHRH
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