Investigation of a New, Oral Growth Hormone Secretagogue, AEZS-130 as a Growth Hormone Stimulation Test.
Status:
Completed
Trial end date:
2011-07-01
Target enrollment:
Participant gender:
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 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.