ISRCTN26461337进行中（未招募）3 期
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)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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)
- •11. Previous severe allergic reaction or anaphylaxis, or adverse reaction to any antigen of ACTH or Synacthen
- •12. Participation in another clinical trial of an investigational or licensed drug or device within the last 3 months
- •13. Unable to comply with the requirements of the protocol
- •14. Any other significant medical or psychiatric conditions that in the opinion of the investigator would preclude participation in the trial
- •15. For nasal visit only - Coryzal symptoms within the last week - just excluded from that visit
研究者
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