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| Sponsored by: |
Ardana Bioscience Ltd |
|---|---|
| Information provided by: | Ardana Bioscience Ltd |
| ClinicalTrials.gov Identifier: | NCT00448747 |
Purpose
The diagnosis of GH 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 GHRH combined with arginine. However, these tests are either bothersome (given intravenously) to the patient or are linked with side effects. Therefore, an orally available compound like 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypopituitarism Hypothalamic Disease |
Drug: ARD-07 |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study |
| Official Title: | A Multi-Center, Randomized, Cross-Over Study Investigating a New, Oral Growth Hormone Secretagogue (GHS)(ARD-07) as a Growth Hormone (GH) Stimulation Test in Terms of Safety and Efficacy Compared to L-ARG+GHRH |
| Estimated Enrollment: | 80 |
| Study Start Date: | June 2007 |
| Estimated Study Completion Date: | June 2008 |
| Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
GHD subjects:
• Confirmed GH deficiency
Matched Normal Controls:
Exclusion Criteria:
Untreated hypothyroidism
Contacts and Locations| United States, California | |
| Cedars-Sinai Medical Center | |
| Los Angeles, California, United States, 90048 | |
| Stanford University | |
| Stanford, California, United States, 94305-5826 | |
| Harbor-UCLA Medical Center | |
| Torrance, California, United States, 90502 | |
| United States, Illinois | |
| Northwestern University | |
| Chicago, Illinois, United States, 60611-3008 | |
| United States, Maryland | |
| Johns Hopkins University | |
| Baltimore, Maryland, United States, 21287 | |
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| United States, Oregon | |
| Oregon Health and Science University | |
| Portland, Oregon, United States, 97239 | |
| United States, Texas | |
| dgd Research | |
| San Antonio, Texas, United States, 78229-4801 | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| United States, Washington | |
| VA Puget Sound HCS | |
| Seattle, Washington, United States, 98493 | |
| Principal Investigator: | Beverly MK Biller, MD | Massachusetts General Hospital, Boston |
More Information
| Responsible Party: | Ardana Bioscience Ltd. ( Ardana Bioscience Ltd. ) |
| Study ID Numbers: | ARD-0705-001 |
| Study First Received: | March 16, 2007 |
| Last Updated: | April 17, 2008 |
| ClinicalTrials.gov Identifier: | NCT00448747 |
| Health Authority: | United States: Food and Drug Administration |
|
Hypothalamic Diseases Pituitary Diseases Hypopituitarism Endocrine System Diseases |
Central Nervous System Diseases Endocrinopathy Brain Diseases |
|
Nervous System Diseases |
