|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT00448747 |
|
Date of registration:
|
16/03/2007 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Investigation of a New, Oral Growth Hormone Secretagogue, AEZS-130 as a Growth Hormone Stimulation Test.
|
|
Scientific title:
|
A Multi-center, Study Investigating a New, Oral Growth Hormone Secretagogue (GHS)(AEZS 130, Formerly Ardana (ARD)-07) as a Growth Hormone (GH) Stimulation Test in Terms of Safety and Efficacy |
|
Date of first enrolment:
|
June 2007 |
|
Target sample size:
|
101 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT00448747 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
|
|
Phase:
|
Phase 3
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Beverly MK Biller, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Massachusetts General Hospital, Boston |
| | |
|
Key inclusion & exclusion criteria
|
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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Diagnosis of Adult Growth Hormone Deficiency (AGDH)
|
|
Intervention(s)
|
|
Drug: AEZS-130 (formerly ARD-07)
|
|
Drug: L-ARG+GHRH
|
|
Primary Outcome(s)
|
|
Receiver Operating Characteristic (ROC) Analysis on Peak GH (Growth Hormon) Concentrations
[Time Frame: GH sampling: pre-dose and 30, 45, 60, 75, 90, 120, 150 min post-dose]
|
|
Secondary Outcome(s)
|
|
Number of Participants With Drug Related Adverse Events (AEs)
[Time Frame: 14 days]
|
|
Classification and Regression Tree (CART) Analysis of Peak Growth Hormone (GH) Following Macimorelin Administration
[Time Frame: GH sampling: pre-dose and 30, 45, 60, 75, 90, 120, 150 min post-dose]
|
|
Peak Insulin-Like Growth Factor (IGF)-1 Concentration Following Treatment
[Time Frame: 15 min. before macimorelin administration and at 150 min after macimorelin administration]
|
|
Secondary ID(s)
|
|
AEZS 130 047
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|