Investigation of a New, Oral Growth Hormone Secretagogue, AEZS-130 as a Growth Hormone Stimulation Test.
Completed · Phase 3
Conditions studied: Diagnosis of Adult Growth Hormone Deficiency (AGDH)
In brief
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.
Key facts
- Study ID
- NCT00448747
- Run by
- AEterna Zentaris
- People needed
- 101
- Starts
- 2007-06-01
- Expected to finish
- 2011-07-01
- Last updated by the study team
- 2019-07-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
Where it is running
- Celerion — Tempe, Arizona, United States
- Cedars-Sinai Medical Center — Los Angeles, California, United States
- Harbor-UCLA Medical Center — Torrance, California, United States
- Northwestern University — Chicago, Illinois, United States
- Radiant Research Inc. — Chicago, Illinois, United States
- John Hopkins University — Baltimore, Maryland, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Celerion — Lincoln, Nebraska, United States
- Celerion — Neptune City, New Jersey, United States
- Oregon Health & Science University — Portland, Oregon, United States
- Baylor College of Medicine — Houston, Texas, United States
- Cetero Research — San Antonio, Texas, United States
- VA Puget Sound HCS University of Washington — Tacoma, Washington, United States
Full record on ClinicalTrials.gov
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