ISRCTN62724177进行中（未招募）Unknown
Clinical validation of a non-invasive diagnostic test for adrenal insufficiency using comparative pharmacodynamic equivalence in a healthy population
适应症
试验速览
- 阶段
- Unknown
- 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
- •Current participant inclusion criteria as of 17/11/2023:
- •1. Healthy men, women and children aged 4-69 years old
- •2. Able to comply with passive drool salivary sampling requirements
- •3. Provision of signed written informed consent
- •Previous participant inclusion criteria:
- •1. Healthy men, women and children aged 2-69 years old
- •2. Able to comply with passive drool salivary sampling requirements
- •3. Provision of signed written informed consent
排除标准
- •1. Known adrenal insufficiency, Cushing's syndrome or any other adrenal or pituitary gland disorder
- •2. Ongoing pregnancy
- •3. Use of oestrogen-containing hormonal contraception / Hormone Replacement Therapy (due to the effect on cortisol levels)
- •4. Known 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, including opioids, oral antifungals, loperamide
- •5. Known and active protein losing disorders, e.g. enteropathy or nephrotic syndrome, who may have a cortisol binding globulin abnormality
- •6. 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).
- •7. Participants on regular, inhaled, topical, nasal, ocular, rectal, oral or intra-articular steroids for any indication in the last 3 months
- •8. Current uncontrolled active infection
- •9. BMI >35 kg/m² (or BMI >3 standard deviations (SD) above the mean for age and sex if <16 years)
- •10. Known or suspected alcohol dependence or drug misuse
- •11. Current smoker or vaper (or within 6 months of cessation)
- •12. Recent (within 1 week) liquorice ingestion (preparations containing glycyrrhizic acid only)
- •13. Individuals with a history of known salivary gland or oral mucosa pathology who are unable to produce a suitable salivary sample (e.g. as a consequence of drugs that cause dry mouth)
- •14. Previous severe allergic reaction or anaphylaxis or adverse reaction to any antigen of ACTH or Synacthen
- •15. Participation in another clinical trial of an investigational or licensed drug within the 3 months prior to inclusion in study
- •16. Participants unable to comply with the requirements of the protocol
- •17. Participants with any other significant medical or psychiatric conditions that in the opinion of the investigator would preclude participation in the trial
- •18. For nasal visits only: coryzal symptoms within the last week (and will be asked to report any new symptoms occurring within 24 hours of the test)
研究者
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