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

Sponsor
The London Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT05350020
Collaborator
(none)
8
1
4
16.6
0.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Solu-Cortef 100 MG Injection
  • Drug: Hydrocortisone 100mg/ml
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
8 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
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
Actual Study Start Date :
Mar 14, 2022
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Solu-Cortef® in deltoid muscle

Solu-Cortef® in deltoid muscle

Drug: Solu-Cortef 100 MG Injection
Licensed medicine used in clinical practice. Preparations will be used unmodified in this trial withinmarketing authorisations.

Experimental: Solu-Cortef® in thigh muscle

Solu-Cortef® in thigh muscle

Drug: Solu-Cortef 100 MG Injection
Licensed medicine used in clinical practice. Preparations will be used unmodified in this trial withinmarketing authorisations.

Experimental: Hydrocortisone 100mg/ml in deltoid muscle

Hydrocortisone 100mg/ml in deltoid muscle

Drug: Hydrocortisone 100mg/ml
Licensed medicine used in clinical practice. Preparations will be used unmodified in this trial within marketing authorisations.

Experimental: Hydrocortisone 100mg/ml in thigh muscle

Hydrocortisone 100mg/ml in thigh muscle

Drug: Hydrocortisone 100mg/ml
Licensed medicine used in clinical practice. Preparations will be used unmodified in this trial within marketing authorisations.

Outcome Measures

Primary Outcome Measures

  1. State of Hypocortisolaemia when injected into deltoid muscle or thigh muscle [4 weeks]

    Measure of Peak Serum Cortisol

Secondary Outcome Measures

  1. 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]

    Verbal Numerical Rating Scale for Pain from 0 (no pain) to 10 (worst pain) Size of needle Injection site used Hydrocortisone preparation

  2. Hydrocortisone absorption [4 Weeks]

    Measured by Injection site circumference measured in Centimeters and BMI (weight in kilograms, height in meters) BMI combined to view Area under curve and Time to peak concentration

  3. Ability to Self-Inject [4 Weeks]

    Measure by assessment of the following: Hypocortisolaemia symptoms Leftover IMP in ampoules (Quanitity of IMP measure in ml to calculate remaining mg of IMP) Time taken to inject

  4. Subjective health status/impact on quality of life [5 Weeks]

    AddiQol score (AddiQol Health-related quality of life in Addison's disease) total score 30 Ability to self-inject

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Age 18-70 inclusive

  2. Written informed consent provided, 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 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.

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 SmPC as being contraindicated or precautionary for use

  5. Patient with concurrent illness in the week preceding screening/study visit.

  6. Patient 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 who is unable or unwilling to comply with the protocol.

  10. Patient taking any medications/substances that are known to interact with hydrocortisone e.g. CYP3A4 inhibitors

  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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The London Clinic London United Kingdom W1G 6HL

Sponsors and Collaborators

  • The London Clinic

Investigators

  • Principal Investigator: Pierre Bouloux, Endocrinology Consultant

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The London Clinic
ClinicalTrials.gov Identifier:
NCT05350020
Other Study ID Numbers:
  • ATC 017
First Posted:
Apr 27, 2022
Last Update Posted:
Apr 27, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 27, 2022