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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02558829 |
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Date of registration:
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21/09/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Validation of Macimorelin as a Test for Adult Growth Hormone Deficiency
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Scientific title:
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Confirmatory Validation of Oral Macimorelin as a Growth Hormone (GH) Stimulation Test (ST) for the Diagnosis of Adult Growth Hormone Deficiency (AGHD) in Comparison With the Insulin Tolerance Test (ITT) |
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Date of first enrolment:
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December 3, 2015 |
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Target sample size:
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157 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02558829 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Austria
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France
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Germany
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Italy
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Poland
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Serbia
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Spain
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United Kingdom
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United States
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Contacts
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Name:
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Jose M Garcia, MD PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Baylor College of Medicine, Houston, TX, U.S. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Suspected growth hormone deficiency (GHD), based on either of the following:
- structural hypothalamic or pituitary disease, or
- surgery or irradiation in these areas, or
- head trauma as an adult, or
- evidence of other pituitary hormone deficiencies, or
- idiopathic childhood onset GHD (without known hypothalamic or pituitary lesion or
injury).
- Healthy* control subjects, matching a 'high likelihood GHD' subjects
Exclusion Criteria:
- GH therapy within 1 month prior to anticipated first GHST within this trial (within 3
months in case of long-acting GH formulation).
- GHST within 7 days prior to the anticipated first test day within the trial.
- Subjects with a medical history and clinical signs of a not adequately treated thyroid
dysfunction or subjects who had a change in thyroid therapy within 30 days prior to
anticipated first test day within the trial.
- Untreated hypogonadism or not on a stable substitution treatment within 30 days prior
to anticipated first test day within the trial.
- Treatment with drugs directly affecting the pituitary secretion of somatotropin (e.g.
somatostatin analogues, clonidine, levodopa, and dopamine agonists) or provoking the
release of somatostatin; antimuscarinic agents (atropine).
- Concomitant use of a CYP3A4 inducer (e.g., carbamazepine, phenobarbital, phenytoin,
pioglitazone, rifabutin, rifampin, St. John's Wort).
- Medical history of ongoing clinically symptomatic severe psychiatric disorders.
- Parkinson's disease.
- Cushing disease or patients on supraphysiologic glucocorticoid therapy within 30 days
prior to the anticipated first test day within the trial.
- Type 1 diabetes or untreated or poorly controlled Type 2 diabetes, as defined by HbA1c
> 8%.
- Body mass index (BMI) = 40.0 kg/m2.
- Participation in a trial with any investigational drug within 30 days prior to trial
entry.
- Vigorous physical exercise within 24 hours prior to each GHST within this trial.
- Known hypersensitivity to macimorelin or insulin, or any of the constituents of either
preparation.
- Clinically significant cardiovascular or cerebrovascular disease.
- Prolonged ECG QT interval, defined as corrected QT interval (QTc) > 500 msec.
- Concomitant treatment with any drugs that might prolong QT/QTc.
- Elevation of laboratory parameters indicating hepatic or renal dysfunction or damage
(aspartate amino transferase (ASAT), alanine aminotransferase (ALAT), gamma-glutamyl
transpeptidase (GGT)> 2.5 x ULN; ), creatinine, or bilirubin > 1.5x ULN).
- Medical history of seizure disorders.
- Known immunosuppression.
- Current active malignancy other than non-melanoma skin cancer.
- Breastfeeding or positive urine pregnancy test (for women of childbearing potential
only).
- Women of childbearing age without contraception, such as hormonal contraception or use
of condom and spermicides or use of diaphragm and spermicides or Intra Uterine Device
(IUD).
- Lack of ability or willingness to give informed consent.
- Anticipated non-availability for trial visits/procedures.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Growth Hormone Deficiency With Pituitary Anomalies
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Intervention(s)
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Drug: Insulin
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Drug: Macimorelin
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Primary Outcome(s)
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Co-primary Efficacy Variables: Percent Positive and Percent Negative Agreement of Macimorelin-GHST (MAC) With ITT
[Time Frame: 90 minutes]
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Secondary Outcome(s)
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Overall Agreements (Positive/ Negative) for MAC and ITT
[Time Frame: 90 minutes]
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Number of Participants With Any Test Emergent Adverse Event (TEAE), With Any TEAE Likely or Possibly Related, and With Any Test Emergent Severe AE
[Time Frame: up to 70 days]
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ECG: Change in Heart Rate From Baseline at 60 Minutes Post-dose
[Time Frame: 60 minutes]
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Secondary ID(s)
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2015-002337-22
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AEZS-130-052
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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