Diagnosis of Adult Growth Hormone Deficiency (AGDH) Clinical Trial
Official title:
A Multi-center, Study Investigating a New, Oral Growth Hormone Secretagogue (GHS)(AEZS 130, Formerly Ardana (ARD)-07) as a Growth Hormone (GH) Stimulation Test in Terms of Safety and Efficacy
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 and/or 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.
Thirty control subjects (i.e., 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.
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