Status:
COMPLETED
Investigation of a New, Oral Growth Hormone Secretagogue, AEZS-130 as a Growth Hormone Stimulation Test.
Lead Sponsor:
AEterna Zentaris
Conditions:
Diagnosis of Adult Growth Hormone Deficiency (AGDH)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 c...
Detailed Description
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 recei...
Eligibility Criteria
Inclusion
- Inclusion for Matched Control Subjects:
- Undergone normal growth and development
- Normal serum prolactin (PRL) concentrations
- Females should have a history of regular, age-appropriate menses
- Males should have normal serum testosterone concentrations
- Matched GHD subject already enrolled in study; matched in terms of sex, age, BMI and Estrogen status (women only)
- Exclusion Criteria for Matched Control Subjects:
- Inability or unwillingness to comply with study medication
- Pregnancy or lactation
- Clinically relevant ECG abnormalities (including QT/QTc interval \> 450 ms) at any time prior to dosing at Visit 2
- Treatment with any drugs that might prolong QT/QTc
- Inclusion criteria dor Adult GHD Subjects:
- Confirmed GH deficiency with a low IGF-1
- 3 months of stable treatment for those requiring hormone replacement therapy for hormones deficiencies other than GHD
- subjects with hypogonadism must be treated with sex steroid therapy, excluding women over 50 yr of age
- women on estrogen therapy, for whatever reason, must be on stable treatment for ar least 3 months prior to study
- Exclusion criteria for Adult GHD Subjects:
- Untreated hypothyroidism
- Known hypersensitivity to any excipient in study medication
- Inability or unwillingness to comply with study procedures
- Intracranial lesions stable for less than 12 months
- GH therapy within one month of study entry
- Clinically significant cardiovascular, or cerebrovascular disease
- Current active malignancy other than non-melanoma skin cancer
- Renal or hepatic dysfunction (\> 3 x ULN liver function enzymes (LFEs) - aspartate amino transferase (ASAT); alanine amino transferase (ALAT); gamma-glutamyltransferase (GGT) or creatinine \> 2x ULN)
- Pregnancy or lactation
- Active Cushing's disease
- Clinically relevant ECG abnormalities (including QT/heart rate corrected QT interval (QTc) interval \> 450 ms) at any time prior to dosing at Visit 2
- Treatment with any drugs that might prolong QT/QTc
Exclusion
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT00448747
Start Date
June 1 2007
End Date
July 1 2011
Last Update
July 23 2019
Active Locations (13)
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1
Celerion
Tempe, Arizona, United States, 85283
2
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
3
Harbor-UCLA Medical Center
Torrance, California, United States, 90502
4
Northwestern University
Chicago, Illinois, United States, 60611-3008