The Effects of Two Brands of Hydrocortisone Injected Intramuscularly Into Deltoid and Thigh Muscles

NCT05350020 | Unknown Phase 4

• 1 other identifier: ATC 017
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Addison's Disease

Outcome Measures

Primary Outcomes (1)

• State of Hypocortisolaemia when injected into deltoid muscle or thigh muscle

  Measure of Peak Serum Cortisol

  4 weeks

Secondary Outcomes (4)

• 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

• Hydrocortisone absorption

  4 Weeks

• Ability to Self-Inject

  4 Weeks

• Subjective health status/impact on quality of life

  5 Weeks

Study Arms (4)

Solu-Cortef® in deltoid muscle

EXPERIMENTAL

Solu-Cortef® in deltoid muscle

Drug: Solu-Cortef 100 MG Injection

Solu-Cortef® in thigh muscle

EXPERIMENTAL

Solu-Cortef® in thigh muscle

Drug: Solu-Cortef 100 MG Injection

Hydrocortisone 100mg/ml in deltoid muscle

EXPERIMENTAL

Hydrocortisone 100mg/ml in deltoid muscle

Drug: Hydrocortisone 100mg/ml

Hydrocortisone 100mg/ml in thigh muscle

EXPERIMENTAL

Hydrocortisone 100mg/ml in thigh muscle

Drug: Hydrocortisone 100mg/ml

Interventions

Solu-Cortef 100 MG Injection DRUG

Licensed medicine used in clinical practice. Preparations will be used unmodified in this trial withinmarketing authorisations.

Solu-Cortef® in deltoid muscle; Solu-Cortef® in thigh muscle

Hydrocortisone 100mg/ml DRUG

Licensed medicine used in clinical practice. Preparations will be used unmodified in this trial within marketing authorisations.

Hydrocortisone 100mg/ml in deltoid muscle; Hydrocortisone 100mg/ml in thigh muscle

Eligibility Criteria

• Age: 18 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The London Clinic: lead

Study Sites (1)

The London Clinic

London, W1G 6HL, United Kingdom

RECRUITING

MeSH Terms

Conditions

Addison Disease

Interventions

hydrocortisone hemisuccinate; Injections; Hydrocortisone

Condition Hierarchy (Ancestors)

Adrenal Insufficiency; Adrenal Gland Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

Study Officials

• Pierre Bouloux

  Endocrinology Consultant

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine Topham

CONTACT

0203 219 3570; clinicalresearch@thelondonclinic.co.uk

Phillip Yeoh

CONTACT

0207 953 4444

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2022
• First Posted: April 27, 2022
• Study Start: March 14, 2022
• Primary Completion: March 1, 2023
• Study Completion: August 1, 2023
• Last Updated: April 27, 2022

Record last verified: 2022-03

Locations

GB (1)