NCT05350020Unknown4 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
The London Clinic1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2022年3月14日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- State of Hypocortisolaemia when injected into deltoid muscle or thigh muscle
研究概览
简要总结
The study will be looking at the cortisol profiles of hypocortisolaemic patients following 100mg injections of two hydrocortisone preparations (Solu-Cortef® & Hydrocortisone 100mg/ml). The investigators plan to use two methods of intramuscular injection to administer the preparations, one using a 1inch orange needle into the deltoid muscle and the other using a 1.25inch blue needle into the thigh muscle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-70 inclusive
- •Written informed consent provided, prior to any study related assessments/procedure being conducted.
- •Men & Women with a BMI between 18-30kg/m2
- •Addison's disease or Bilateral Adrenalectomised patients with pre-hydrocortisone cortisol level below 100nmol/L and ACTH greater than 50ng/L on screening visit
- •All patients must be stabilised on hydrocortisone with no change in dosage for 6 months, other than transient increases for concurrent illness.
- •Able to self-inject into deltoid and thigh muscles following teaching at recruitment.
- •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 patient's 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.
排除标准
- •Patient on oestrogen based or mixed oral contraceptives unless willing to use alternate effective method of contraception
- •Patient on any forms of oral steroids other than hydrocortisone.
- •Any patient with secondary adrenal failure
- •Patients with a diagnosis of any disease or condition listed in Hydrocortisone 100mg/ml and Solu-Cortef®'s SmPC as being contraindicated or precautionary for use
- •Patient with concurrent illness in the week preceding screening/study visit.
- •Patient must not have had an adrenal crisis in the week before screening
- •Patient with Nelson's syndrome.
- •Participating in another IMP investigation
- •Patient who is unable or unwilling to comply with the protocol.
- •Patient taking any medications/substances that are known to interact with hydrocortisone e.g. CYP3A4 inhibitors
- •Pregnant or breastfeeding patients
- •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
研究组 & 干预措施
Solu-Cortef® in deltoid muscle
Experimental
Solu-Cortef® in deltoid muscle
干预措施: Solu-Cortef 100 MG Injection (Drug)
Solu-Cortef® in thigh muscle
Experimental
Solu-Cortef® in thigh muscle
干预措施: Solu-Cortef 100 MG Injection (Drug)
Hydrocortisone 100mg/ml in deltoid muscle
Experimental
Hydrocortisone 100mg/ml in deltoid muscle
干预措施: Hydrocortisone 100mg/ml (Drug)
Hydrocortisone 100mg/ml in thigh muscle
Experimental
Hydrocortisone 100mg/ml in thigh muscle
干预措施: Hydrocortisone 100mg/ml (Drug)
结局指标
主要结局
State of Hypocortisolaemia when injected into deltoid muscle or thigh muscle
时间窗: 4 weeks
Measure of Peak Serum Cortisol
次要结局
- Pain perception following use of difference sizes of needles (1inch orange needle versus 1.25inch blue needle), muscle groups (deltoid versus thigh) and hydrocortisone preparations (Solu-Cortef® versus Hydrocortisone 100mg/ml)(4 Weeks)
- Ability to Self-Inject(4 Weeks)
- Hydrocortisone absorption(4 Weeks)
- Subjective health status/impact on quality of life(5 Weeks)
研究者
研究点 (1)
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