ISRCTN26461337
Active, Not Recruiting
Phase 3
Clinical Validation of a Non-Invasive Diagnostic Test for Adrenal Insufficiency using Comparative Pharmacodynamic Equivalence in a Patient Population Salivary Test of Adrenal Response to Liquid Intranasal Tetracosactide - Study 3 (STARLIT-3)
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Adrenal insufficiency
- Sponsor
- Sheffield Children's NHS Foundation Trust
- Enrollment
- 32
- Status
- Active, Not Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Known adrenal insufficiency
- •2\. Basal cortisol \<100 nmol/L or peak on SST \<200 nmol/L at time of diagnosis or since in last 6 months
- •3\. Able to comply with passive drool salivary sampling requirements
- •4\. Able to provide signed written informed consent
- •5\. Age 4\-75 years
Exclusion Criteria
- •1\. Ongoing pregnancy
- •2\. Use of oestrogen\-containing hormonal contraception / Hormone Replacement Therapy (due to the effect on cortisol levels)
- •3\. Co\-morbid condition requiring daily administration of a medication that interferes with the metabolism of glucocorticoids, e.g. known to affect corticosteroid\-binding globulin (CBG), including all oestrogens, or the hypothalamic\-pituitary\-adrenal (HPA) axis, such as loperamide, oral antifungals and opiates
- •4\. Known and active protein losing disorder, e.g. enteropathy or nephrotic syndrome, which may result in a cortisol binding globulin abnormality
- •5\. Known clinical or biochemical evidence of hepatic or renal disease. Creatinine over twice the upper limit of normal (ULN) or elevated liver function tests (alanine transaminase (ALT) or aspartate transaminase (AST) \>3 times the ULN
- •6\. Current uncontrolled active infection (may include later in the trial at clinician's discretion if completely resolved)
- •7\. Known or suspected alcohol dependence or drug misuse
- •8\. Current smoker or vaper (or within 6 months of cessation)
- •9\. Recent (within last 1 week) liquorice ingestion (preparations containing glycyrrhizic acid only)
- •10\. History of known salivary gland or oral mucosa pathology or unable to produce a suitable salivary sample (e.g. as a consequence of drugs that cause dry mouth)
Outcomes
Primary Outcomes
Not specified
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