Addison's Disease MedDRA version: 20.1 Level: PT Classification code 10001130 Term: Addison's disease System Organ Class: 10014698 - Endocrine disorders
Conditions
Interventions
Trade Name: Solu-Cortef
Product Name: Solu-Cortef
Pharmaceutical Form: Powder for injection
INN or Proposed INN: Hydrocortisone
CAS Number: 50237
Concentration unit: mg milligram(s)
Concentration type
Sponsors
The London Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess whether IM Hydrocortisone Injection site using deltoid muscle is equally effective to thigh muscle during the state of hypocortisolaemia in patients with cortisol deficiency assessed by serum cortisol profiles;Secondary Objective: To investigate any differences in pain perception using differences sizes of needles, muscle groups (deltoid versus thigh) and hydrocortisone preparations (Solu-Cortef vesus Hydrocortisone 100mg/ml) To understand if circumference of injections site and patient's BMI affect hydrocortisone absorption To assess following nurse education on hydrocortisone self-injection whether the patient is able to self-inject during their state of hypocortisolaemia To assess if the number of taught self-injections has an impact of patient's quality of life.;Primary end point(s): Peak serum cortisol, mean cortisol, time to peak and serum cortisol area under curve following deltoid and thigh muscle injections of hydrocortisone (Hydrocortisone 100mg/ml versus Solu-Cortef®).;Timepoint(s) of evaluation of this end point: 0.5hour, 1 hour, 2 hours, 6 hours and 8 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Injection site circumference to cortisol area under curve and time to peak BMI to cortisol area under curve and time to peak Leftover of hydorcortisone in ampoultes to serum cortisol area under curve and time to peak Overall pain scores for both preparations and each of those Size of needles to pain scores Injection sites circumference to pain scores Hypocortisolaemia symptoms and ability to self-inject Hydrocortisone preparations and ability to self-inject AddiQoL scores and ability to self-inject;Timepoint(s) of evaluation of this end point: Injection site measurement will be taken immediately after the injection BMI will be collected on screening visit. Leftover of hydrocortisone in ampoules will be measured after patient has administered the injection. Pain score will be collected immediately after the injection then at 1 hour, 8 hours and 72 hours post injection. Symptoms for hypocortisolaemia will be collected before hydrocortisone injection then at 6 hours The name of the hydrocortisone will be recorded after each injection. AddiQoL score will complete AddiQoL at baseline visit and at the end of the study or when they decided to terminate from the study | — |
Countries
United Kingdom
Contacts
Public ContactPhillip Yeoh Endocrinology Dept
The London Clinic
Outcome results
None listed