Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2025-12-30 @ 10:11 AM
Study NCT ID:
NCT00489294
Status:
COMPLETED
Last Update Posted:
2012-03-12
First Post:
2007-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Study of Syntropin (Human Growth Hormone) for the Treatment of Growth Hormone Deficiency
Sponsor:
Phage Pharmaceuticals, Inc.
Organization:
Study Overview
Official Title:
An Open-Label Study of the Pharmacokinetics and Pharmacodynamics of Syntropin (a Human Growth Hormone) in Growth Hormone-Suppressed Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2012-03
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 purpose of this study is to evaluate the pharmacokinetics of Syntropin (a human growth hormone) and to determine the serum concentration of IGF-1 after Syntropin injection.
Detailed Description:
Syntropin will be administered by subcutaneous injection. Eligible patients will receive a subcutaneous injection of octreodite (to suppress endogenous growth hormone secretion) 12 hours before, immediately prior to, and 12 hours after the scheduled injection of growth hormone.
Study Oversight
Has Oversight DMC:
True
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?: