EUCTR2009-013355-29-GB进行中（未招募）1 期
A multi-stage clinical study to develop a non-invasive Short Synacthen Test (SST) with nasally administered synacthen and salivary cortisol. The validated non-invasive SST will be used to establish normative data in children and to detect adrenal suppression in asthmatic children. - The development of a non-invasive Short Synacthen Test - NeSST Study
Sheffield Children's NHS Foundation Hospital0 个研究点目标入组 258 人开始时间: 2010年6月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 258
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Stage 1(a+b): Healthy, male volunteers aged 18-64, with no exclusion criteria listed below.
- •Stage 2: Healthy children of either sex, aged between 2 years and 15 years, with no exclusion criteria listed below.
- •Stage 3: Healthy children of both sexes, aged between 6 months and 15 years, without exclusion criteria 1,2,3,5,6,7,8,9,10,11,12 and 14 listed below.
- •Phase 4: Children of both sexes, aged between 6 months and 15 years, prescribed varying doses of regular inhaled corticosteroids and without exclusion criteria 1,5,9,10,11,12 and 14 as listed below.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Past or present history of an endocrinopathy.
- •2. Past or present history of asthma.
- •3. Past or present history of allergic rhinitis
- •4. Past or present history of peptic ulcer disease/GI bleed/significant dyspepsia.
- •5. Past history of intra-cranial, renal or adrenal pathology.
- •6. Presently on any prescribed medication.
- •7. Presently, or within the last 3 months, been prescribed any type of corticosteroid (oral, inhaled, nasal, rectal, intravenous, intramuscular, intra-articular, intra-ocular, topical).
- •8. Ever been prescribed a prolonged course (more than 1 month) of oral steroids.
- •9. Previous serious allergic reaction or an episode of anaphylaxis.
- •10. Previous adverse reaction (including mild hypersensitivity)to ACTH or synacthen.
- •11. Coryzal symptoms within the last week.
- •12. Current smoker.
- •13. Body Mass Index more than 30.
- •14. Currently pregnant
- •15. Currently anaemic
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