EUCTR2015-001090-40-GB进行中（未招募）1 期
An open label pilot study to investigate the effects of two preparations of hydrocortisone (Hydrocortisone 100mg/ml and Solu-Cortef) injected intramuscularly into the deltoid and upper thigh muscle during the state of hypocortisolaemia - Effects of 100mg Hydrocortisone injection into Deltoid & Thigh
The London Clinic0 个研究点目标入组 8 人开始时间: 2015年4月8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
- 8
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
- •1. Age 18-70 inclusive
- •2. Written informed consent obtained prior to any study related assessments/procedure being conducted.
- •3. Men & Women with a BMI between 18-30kg/m2
- •4. Addison’s disease or Bilateral Adrenalectomised patients with pre hydrocortisone cortisol level below 100nmol/L and ACTH greater than 50ng/L on screening visit
- •5. All patients must be stabilised on hydrocortisone with no change in dosage for 6 months, other than transient increases for concurrent illness.
- •6. Able to self-inject into deltoid and thigh muscles following teaching at recruitment.
- •7. Female patients of child-bearing potential must be willing to use an acceptable method of birth control/abstinence from the time consent is signed until 6 weeks after treatment is discontinued. Acceptable methods include: physical barrier (male or female condom, contraceptive sponges, diaphragms and cervical caps), contraceptive pill or patch, spermicidal method alongside a physical barrier or an intrauterine device (IUD). Abstinence is also acceptable if it falls in line with the patients’ usual lifestyle however it must be complete abstinence and not either; periodic, ovulation timed, symptothermal or withdrawal based. Those patients that utilise hormonal contraceptives must have used the same method for at least three months before additional barrier contraception (as described above). Patients of non-child-bearing potential are defined as having 12 month amenorrhoea or are surgically sterile.
- •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 7
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •1. Patient on oestrogen based or mixed oral contraceptives unless willing to use alternate effective method of contraception
- •2. Patient on any forms of oral steroids other than hydrocortisone.
- •3. Any patient with secondary adrenal failure
- •4. Patients with a diagnosis of any disease or condition listed in Hydrocortisone 100mg/ml and Solu-Cortef®’s as being contraindicated or precautionary for use
- •5. Patient with concurrent illness in the week preceding screening/study visit.
- •6. Patients must not have had an adrenal crisis in the week before screening
- •7. Patient with Nelson’s syndrome.
- •8. Participating in another IMP investigation
- •9. Patient taking any medications/substances that are known to interact with hydrocortisone e.g. CYP3A4 inhibitors
- •10. Patient is unable or unwilling to comply with the protocol.
- •11. Pregnant or breastfeeding patients
- •12. Patient has any other disease or condition that, in the opinion of the investigator, might compromise patient safety or interfere with the results of the trial
研究者
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