EUCTR2012-001104-37-GB进行中（未招募）不适用
Pulsed glucocorticoid replacement therapy for patients with adrenocortical insufficiency secondary to Addison’s disease and congenital adrenal hyperplasia - the pulses study
niversity Hospitals Bristol NHS Foundation Trust0 个研究点开始时间: 2014年7月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •Male and female patients with confirmed Addison’s disease and CAH
- •Aged 18 to 64 years
- •Females of child bearing potential must be using a highly effective method of contraception / birth control as defined in ICH (M3) if sexually active
- •Right handed
- •Able to give informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Any significant current cerebral, cardiovascular, respiratory, hepatobiliary, pancreatic disease, renal dysfunction, gastrointestinal emptying or motility disturbances.
- •No current treatment or within the last 3 months of another underlying disease that could necessitate treatment with glucocorticoids
- •Taking of medications that interfere with cortisol metabolism (antiepileptics, St Johns wart, rifampicin)
- •Diagnosis of Addison’s disease less than 6 months ago
- •Pregnant or lactating women
- •Greater than 21 units of alcohol per week
- •Taking of any investigational drug within the past two months
- •Known allergy to any of the study medications and /or materials used in the pump
- •Needle phobia
- •Contraindication to fMRI scan i.e. metal implant/shrapnel
- •Claustrophobia
- •Left handed/ambidextrous
研究者
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