Addison's DiseasePhase 4NCT05350020
The Effects of Two Brands of Hydrocortisone Injected Intramuscularly Into Deltoid and Thigh Muscles
A Phase 4 study testing Solu-Cortef 100 MG Injection and Hydrocortisone 100mg/ml in people with Addison's Disease, run by The London Clinic at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Addison's Disease
- What is being tested?
- Solu-Cortef 100 MG Injection and Hydrocortisone 100mg/ml
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Mar 2022to Aug 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Phillip Yeoh contact
United Kingdom1 site, 1 recruiting
- Recruiting
The London Clinic
London, W1G 6HL
Phillip Yeoh
About this study
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
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
- Being tested
- Solu-Cortef 100 MG Injection, Hydrocortisone 100mg/ml
- Medical subject headings
- Addison Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solu-Cortef 100 MG InjectionDrug
Licensed medicine used in clinical practice. Preparations will be used unmodified in this trial withinmarketing authorisations.
Hydrocortisone 100mg/mlDrug
Licensed medicine used in clinical practice. Preparations will be used unmodified in this trial within marketing authorisations.
| Study group | Role | What they receive |
|---|---|---|
| Solu-Cortef® in deltoid muscle | Experimental | Solu-Cortef® in deltoid muscle Receives: Drug: Solu-Cortef 100 MG Injection |
| Solu-Cortef® in thigh muscle | Experimental | Solu-Cortef® in thigh muscle Receives: Drug: Solu-Cortef 100 MG Injection |
| Hydrocortisone 100mg/ml in deltoid muscle | Experimental | Hydrocortisone 100mg/ml in deltoid muscle Receives: Drug: Hydrocortisone 100mg/ml |
| Hydrocortisone 100mg/ml in thigh muscle | Experimental | Hydrocortisone 100mg/ml in thigh muscle Receives: Drug: Hydrocortisone 100mg/ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
State of Hypocortisolaemia when injected into deltoid muscle or thigh muscle
Measure of Peak Serum Cortisol
Measured: 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)
Verbal Numerical Rating Scale for Pain from 0 (no pain) to 10 (worst pain) Size of needle Injection site used Hydrocortisone preparation
Measured: 4 Weeks
Hydrocortisone absorption
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
Measured: 4 Weeks
Ability to Self-Inject
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
Measured: 4 Weeks
Subjective health status/impact on quality of life
AddiQol score (AddiQol Health-related quality of life in Addison's disease) total score 30 Ability to self-inject
Measured: 5 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start14 Mar 2022
- Primary completionMar 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Addison's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The London Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Bouloux, Principal investigator, Endocrinology Consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05350020
- Sponsor's protocol ID
- ATC 017
- Status last verified
- Mar 2022
- First submitted
- 29 Mar 2022
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05350020
- Acronym / sponsor ID
- ATC 017
- Conditions
- Addison's Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- The London ClinicUniversity, hospital or other
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 27 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Solu-Cortef® in deltoid muscle | Experimental | Drug: Solu-Cortef 100 MG InjectionSolu-Cortef® in deltoid muscle |
| Solu-Cortef® in thigh muscle | Experimental | Drug: Solu-Cortef 100 MG InjectionSolu-Cortef® in thigh muscle |
| Hydrocortisone 100mg/ml in deltoid muscle | Experimental | Drug: Hydrocortisone 100mg/mlHydrocortisone 100mg/ml in deltoid muscle |
| Hydrocortisone 100mg/ml in thigh muscle | Experimental | Drug: Hydrocortisone 100mg/mlHydrocortisone 100mg/ml in thigh muscle |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Solu-Cortef 100 MG InjectionLicensed medicine used in clinical practice. Preparations will be used unmodified in this trial withinmarketing authorisations. | Drug | Solu-Cortef® in deltoid muscle, Solu-Cortef® in thigh muscle |
| Hydrocortisone 100mg/mlLicensed medicine used in clinical practice. Preparations will be used unmodified in this trial within marketing authorisations. | Drug | Hydrocortisone 100mg/ml in deltoid muscle, Hydrocortisone 100mg/ml in thigh muscle |
Primary outcome
State of Hypocortisolaemia when injected into deltoid muscle or thigh muscle
Time frame: 4 weeks
Measure of Peak Serum Cortisol
4 secondary outcomes
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)
Time frame: 4 Weeks
Hydrocortisone absorption
Time frame: 4 Weeks
Ability to Self-Inject
Time frame: 4 Weeks
Subjective health status/impact on quality of life
Time frame: 5 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Phillip Yeoh contact
Pierre Bouloux principal investigator
Endocrinology Consultant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Solu-Cortef 100 MG Injection and Hydrocortisone 100mg/ml in people with Addison's Disease, run by The London Clinic at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christine Topham (0203 219 3570, clinicalresearch@thelondonclinic.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State of Hypocortisolaemia when injected into deltoid muscle or thigh muscle (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2022.