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NCT00448747 · ClinicalTrials.gov registry record · Phase 3
Investigation of a New, Oral Growth Hormone Secretagogue, AEZS-130 as a Growth Hormone Stimulation Test.
A Phase 3 study, sponsored by AEterna Zentaris.
- Completed
- Registry status
- Phase 3
- Development phase
- 101
- Enrollment target
NCT00448747 is a Phase 3 study that has completed, run by AEterna Zentaris. The registered enrollment target is 101 participants.
The verdict
NCT00448747, a Phase 3 study, has completed, sponsored by AEterna Zentaris.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 101 participants
- Enrollment target
Study 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.
Interventions
- DRUG AEZS-130 (formerly ARD-07)
- DRUG L-ARG+GHRH
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2007-06 |
| Est. Completion | 2011-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00448747
The ClinicalTrials.gov registry entry for NCT00448747 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 101 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AEterna Zentaris, which has 21 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which AEZS-130 (formerly ARD-07) is the first listed.
NCT00448747 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00448747 about?
NCT00448747 is a clinical study titled "Investigation of a New, Oral Growth Hormone Secretagogue, AEZS-130 as a Growth Hormone Stimulation Test.". 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) an...
What is the current status of trial NCT00448747?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 101 participants. The study started on 2007-06. Estimated completion is 2011-07.
What interventions are being tested in trial NCT00448747?
The interventions under investigation include: AEZS-130 (formerly ARD-07) (DRUG), L-ARG+GHRH (DRUG).
Who is sponsoring clinical trial NCT00448747?
This trial is sponsored by AEterna Zentaris, which has 21 total clinical trials registered on ClinicalTrials.gov.
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