Healthy VolunteersPhase 1CORENCT04733144
Bioequivalence Study of Prednisolone and Dexamethasone
A Phase 1 study testing Prednisolone and Dexamethasone in people with Healthy Volunteers, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
The purpose of this study is to compare two different glucocorticoids, prednisolone and dexamethasone at two different doses for their organ specific effects, utilizing modern day standards. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Prednisolone and Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteNetherlands
- Study dates
- 4 Mar 2021to 31 May 2022
- Phase
- Phase 1
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must be healthy with no relevant medical history and no use of medication.
- Female participants aged <50 years must be using oral contraceptives and female participants age ≥50 years must be in the postmenopausal state
- Command of the Dutch language
- Providing written IC
- BMI between 18.5 and 30 kg/m2
- Participants must be between 18 and 75 years of age
Who cannot join
- Potential participants who are unlikely to adhere to the study protocol (for instance subjects which have a history of substance abuse or non-compliance)
- Potential participants with a medical history of:
- Diseases affecting the HPA-axis: e.g. primary and secondary adrenal insufficiency, pituitary tumors, and nightshift workers
- Diseases affecting the HPG-axis: e.g. Cushing disease.
- Chronic inflammatory diseases: e.g. rheumatoid arthritis, polymyalgia rheumatic, and asthma
- Psychiatric diseases
Show all 10Show fewer
- Diabetes
- Shift workers
- Potential participants with a kidney function <60 ml/min/1.73m2, abnormalities in liver enzymes, and/or abnormalities in thyroid function
- Potential participants who are dependent on corticosteroids, e.g. asthmatic patients, and transplant recipients
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Groningen
Groningen, 9713 GZ
Suzanne P. Stam, MD, 0031503617293, s.p.stam@umcg.nl
Annet Vulto, MD, 0031503617293, a.vulto@umcg.nl
About this study
Official title: An Bioequivalence Study of Prednisolone and Dexamethasone; Corticosteroids Revised - The CORE Study
The purpose of this study is to compare two different glucocorticoids, prednisolone and dexamethasone at two different doses for their organ specific effects, utilizing modern day standards.
Read the detailed description
Study design: A randomised, double blind, cross-over clinical trial.
Study population: healthy human adult volunteers including 12 males and 12 females aged 18-75 years old.
Intervention: In random order, subjects will receive 7,5 mg prednisolone for one week, directly followed by 30 mg of prednisolone for one week. After a washout period of 4 weeks (or by exception 8 weeks), subjects will receive 1,125 mg dexamethasone for one week, directly followed by 4,5 mg dexamethasone for one week.
Main study parameters/endpoints: The main study endpoint is the difference in total urinary cortisol excretion as measured in 24h-urine between the lower doses of prednisolone and dexamethasone as well as between the higher doses of prednisolone and dexamethasone.
- Conditions
- Healthy Volunteers
- Being tested
- Prednisolone, Dexamethasone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoloneDrug
7,5 mg prednisolone (low dose) 30 mg prednisolone (high dose)
DexamethasoneDrug
1,125 mg dexamethasone 4,5 mg dexamethasone
| Study group | Role | What they receive |
|---|---|---|
| Prednisolone-Dexamethasone | Active comparator | Participants will receive 1 week of low dose (7,5 mg) prednisolone directly followed by 1 week of high dose prednisolone (30 mg). After a wash-out period, participants in this arm will receive 1 week of low dose dexamethasone (1,125 mg) directly followed by 1 week of high dose dexamethasone (4,5 mg). Receives: Drug: Prednisolone; Drug: Dexamethasone |
| Dexamethasone-Prednisolone | Active comparator | Participants will receive 1 week of low dose (1,125 mg) dexamethasone directly followed by 1 week of high dose dexamethasone (30 mg). After a wash-out period, participants in this arm will receive 1 week of low dose prednisolone (7,5 mg) directly followed by 1 week of high dose prednisolone (30 mg). Receives: Drug: Prednisolone; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suppression of the hypothalamic-pituitary-adrenal axis - low dose
Difference in HPA-axis suppression as measured by the difference of total urinary cortisol excretion in 24h-urine between 7,5 mg prednisolone and 1,125 mg dexamethasone
Measured: 1 week per treatment
Suppression of the hypothalamic-pituitary-adrenal axis - high dose
Difference of total urinary cortisol excretion in 24h-urine between 30 mg prednisolone (preceded by 7,5 mg prednisolone for one week) and 4,5 mg dexamethasone (preceded by 1,125 mg dexamethasone for one week)
Measured: 1 week per treatment
Secondary outcomes (28)
Changes in hypothalamic-pituitary-adrenal axis suppression - 1
Effect of a dosage increase from low dose to high dose prednisolone on total urinary cortisol excretion in 24h-urine
Measured: 1 week per treatment
Changes in hypothalamic-pituitary-adrenal axis suppression - 2
Effect of a dosage increase from low dose to high dose dexamethasone on total urinary cortisol excretion in 24h-urine
Measured: 1 week per treatment
Suppression of the hypothalamic-pituitary-adrenal axis - plasma cortisol
The between-group difference in plasma cortisol levels
Measured: 1 week per treatment
Suppression of the hypothalamic-pituitary-adrenal axis - ACTH
The between-group difference in adrenocorticotropic hormone levels
Measured: 1 week per treatment
Suppression of the hypothalamic-pituitary-adrenal axis - metabolites of the 24h-urine steroid profile
The between-group difference in metabolites of the 24h-urine steroid profile
Measured: 1 week per treatment
Suppression of the hypothalamic-pituitary-gonadal axis - androgen profile
The between-group difference in androgen profiles
Measured: 1 week per treatment
Suppression of the hypothalamic-pituitary-gonadal axis - gonadotropins
The between-group difference in luteinizing hormone and follicle stimulating hormone
Measured: 1 week per treatment
Suppression of the hypothalamic-pituitary-gonadal axis - metabolites of the 24h-urine steroid profile
The between-group difference in metabolites of the 24h-urine steroid profile
Measured: 1 week per treatment
Pharmacokinetics
Area under the curve
Measured: 1 week per treatment
Suppression of the immune system - granulocyte count
The between-group difference in granulocyte count
Measured: 1 week per treatment
Suppression of the immune system - PBMCs
The between-group difference in peripheral blood mononuclear cell count
Measured: 1 week per treatment
Effect on blood pressure
The between-group difference in systolic and diastolic blood pressure
Measured: 1 week per treatment
Effect on the Renin-angiotensin-aldosterone system - plasma renin
The between-group difference in plasma renin
Measured: 1 week per treatment
Effect on the Renin-angiotensin-aldosterone system - aldosterone
The between-group difference in aldosterone
Measured: 1 week per treatment
Effect on the Renin-angiotensin-aldosterone system - plasma potassium
The between-group difference in plasma potassium
Measured: 1 week per treatment
Effect on the Renin-angiotensin-aldosterone system - 24h-urine potassium
The between-group difference in 24h-urine potassium
Measured: 1 week per treatment
Effect on the Renin-angiotensin-aldosterone system - trans-tubular potassium gradient
The between-group difference in trans-tubular potassium gradient
Measured: 1 week per treatment
Metabolic parameters - OGTT
The between-group difference in oral glucose tolerence tests
Measured: 1 week per treatment
Metabolic parameters - lipid profile
The between-group difference in lipid profile
Measured: 1 week per treatment
Metabolic parameters - NEFAs
The between-group difference in non-esterified fatty acids
Measured: 1 week per treatment
Muscle mass
The between-group difference in 24h urinary creatinine excretion rate
Measured: 1 week per treatment
Muscle strength
The between-group difference in handgrip strength
Measured: 1 week per treatment
Clinical parameters - Weight
The between-group difference in weight in kg
Measured: 1 week per treatment
Clinical parameters - Body Mass Index (BMI)
The between-group difference in BMI in kg/m2
Measured: 1 week per treatment
Clinical parameters - Waist circumference
The between-group difference in waist circumference in cm
Measured: 1 week per treatment
Clinical parameters - Hip circumference
The between-group difference in hip circumference in cm
Measured: 1 week per treatment
Questionnaires - Quality of life
The between-group difference in quality of life, measured using the 36-Item Short Form Health Survey (SF-36). The score ranges from 0-100, with lower scores indicating a worse health status.
Measured: 1 week per treatment
(Serious) Adverse Events
The between-group difference in (serious) adverce events
Measured: 1 week per treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start4 Mar 2021
- Primary completion31 May 2022 (estimated)
- Study completion31 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, A.P. van Beek, MD PhD, University Medical Center Groningen
- Investigators
- André P. van Beek, MD,PhD, Principal investigator, University Medical Center GroningenStephan J.L. Bakker, MD,PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04733144
- Sponsor's protocol ID
- 201900874
- Other IDs
- 2019-004983-23, 2019
- Acronym
- CORE
- Status last verified
- Apr 2022
- First submitted
- 15 Jan 2021
- Last updated
- 12 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After deidentification, individual data that are the foundation of the results reported in future manuscripts can be made available (text, tables, figures, and appendices).
Publications
Stam SP, Vulto A, Vos MJ, Kerstens MN, Rutgers A, Kema I, Touw DJ, Bakker SJ, van Beek AP. Rationale and design of the CORE (COrticosteroids REvised) study: protocol. BMJ Open. 2022 Apr 26;12(4):e061678. doi: 10.1136/bmjopen-2022-061678.
PubMed 35473729
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Bioequivalence Study of Prednisolone and Dexamethasone; Corticosteroids Revised - The CORE Study
- ClinicalTrials.gov ID
- NCT04733144
- Acronym / sponsor ID
- CORE / 201900874
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 4 Mar 2021 (actual)
- Primary completion
- 31 May 2022 (estimated)
- Study completion
- 31 May 2022 (estimated)
- First posted
- 1 Feb 2021 (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 purpose of this study is to compare two different glucocorticoids, prednisolone and dexamethasone at two different doses for their organ specific effects, utilizing modern day standards.
Detailed description
Study design: A randomised, double blind, cross-over clinical trial.
Study population: healthy human adult volunteers including 12 males and 12 females aged 18-75 years old.
Intervention: In random order, subjects will receive 7,5 mg prednisolone for one week, directly followed by 30 mg of prednisolone for one week. After a washout period of 4 weeks (or by exception 8 weeks), subjects will receive 1,125 mg dexamethasone for one week, directly followed by 4,5 mg dexamethasone for one week.
Main study parameters/endpoints: The main study endpoint is the difference in total urinary cortisol excretion as measured in 24h-urine between the lower doses of prednisolone and dexamethasone as well as between the higher doses of prednisolone and dexamethasone.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prednisolone-Dexamethasone | Active comparator | Drug: Prednisolone, Drug: DexamethasoneParticipants will receive 1 week of low dose (7,5 mg) prednisolone directly followed by 1 week of high dose prednisolone (30 mg). After a wash-out period, participants in this arm will receive 1 week of low dose dexamethasone (1,125 mg) directly followed by 1 week of high dose dexamethasone (4,5 mg). |
| Dexamethasone-Prednisolone | Active comparator | Drug: Prednisolone, Drug: DexamethasoneParticipants will receive 1 week of low dose (1,125 mg) dexamethasone directly followed by 1 week of high dose dexamethasone (30 mg). After a wash-out period, participants in this arm will receive 1 week of low dose prednisolone (7,5 mg) directly followed by 1 week of high dose prednisolone (30 mg). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants must be healthy with no relevant medical history and no use of medication.
- Female participants aged <50 years must be using oral contraceptives and female participants age ≥50 years must be in the postmenopausal state
- Command of the Dutch language
- Providing written IC
- BMI between 18.5 and 30 kg/m2
Key exclusion criteria (10 listed)
- Potential participants who are unlikely to adhere to the study protocol (for instance subjects which have a history of substance abuse or non-compliance)
- Potential participants with a medical history of:
- Shift workers
- Potential participants with a kidney function <60 ml/min/1.73m2, abnormalities in liver enzymes, and/or abnormalities in thyroid function
- Potential participants who are dependent on corticosteroids, e.g. asthmatic patients, and transplant recipients
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 |
|---|---|---|
| Prednisolone7,5 mg prednisolone (low dose) 30 mg prednisolone (high dose) | Drug | Dexamethasone-Prednisolone, Prednisolone-Dexamethasone |
| Dexamethasone1,125 mg dexamethasone 4,5 mg dexamethasone | Drug | Dexamethasone-Prednisolone, Prednisolone-Dexamethasone |
Primary outcome
Suppression of the hypothalamic-pituitary-adrenal axis - low dose
Time frame: 1 week per treatment
Difference in HPA-axis suppression as measured by the difference of total urinary cortisol excretion in 24h-urine between 7,5 mg prednisolone and 1,125 mg dexamethasone
Suppression of the hypothalamic-pituitary-adrenal axis - high dose
Time frame: 1 week per treatment
Difference of total urinary cortisol excretion in 24h-urine between 30 mg prednisolone (preceded by 7,5 mg prednisolone for one week) and 4,5 mg dexamethasone (preceded by 1,125 mg dexamethasone for one week)
28 secondary outcomes
Changes in hypothalamic-pituitary-adrenal axis suppression - 1
Time frame: 1 week per treatment
Changes in hypothalamic-pituitary-adrenal axis suppression - 2
Time frame: 1 week per treatment
Suppression of the hypothalamic-pituitary-adrenal axis - plasma cortisol
Time frame: 1 week per treatment
Suppression of the hypothalamic-pituitary-adrenal axis - ACTH
Time frame: 1 week per treatment
Suppression of the hypothalamic-pituitary-adrenal axis - metabolites of the 24h-urine steroid profile
Time frame: 1 week per treatment
Suppression of the hypothalamic-pituitary-gonadal axis - androgen profile
Time frame: 1 week per treatment
Suppression of the hypothalamic-pituitary-gonadal axis - gonadotropins
Time frame: 1 week per treatment
Suppression of the hypothalamic-pituitary-gonadal axis - metabolites of the 24h-urine steroid profile
Time frame: 1 week per treatment
Pharmacokinetics
Time frame: 1 week per treatment
Suppression of the immune system - granulocyte count
Time frame: 1 week per treatment
Suppression of the immune system - PBMCs
Time frame: 1 week per treatment
Effect on blood pressure
Time frame: 1 week per treatment
Effect on the Renin-angiotensin-aldosterone system - plasma renin
Time frame: 1 week per treatment
Effect on the Renin-angiotensin-aldosterone system - aldosterone
Time frame: 1 week per treatment
Effect on the Renin-angiotensin-aldosterone system - plasma potassium
Time frame: 1 week per treatment
Effect on the Renin-angiotensin-aldosterone system - 24h-urine potassium
Time frame: 1 week per treatment
Effect on the Renin-angiotensin-aldosterone system - trans-tubular potassium gradient
Time frame: 1 week per treatment
Metabolic parameters - OGTT
Time frame: 1 week per treatment
Metabolic parameters - lipid profile
Time frame: 1 week per treatment
Metabolic parameters - NEFAs
Time frame: 1 week per treatment
Muscle mass
Time frame: 1 week per treatment
Muscle strength
Time frame: 1 week per treatment
Clinical parameters - Weight
Time frame: 1 week per treatment
Clinical parameters - Body Mass Index (BMI)
Time frame: 1 week per treatment
Clinical parameters - Waist circumference
Time frame: 1 week per treatment
Clinical parameters - Hip circumference
Time frame: 1 week per treatment
Questionnaires - Quality of life
Time frame: 1 week per treatment
(Serious) Adverse Events
Time frame: 1 week per treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
- Derived from this study: PubMed 35473729Stam SP, Vulto A, Vos MJ, Kerstens MN, Rutgers A, Kema I, Touw DJ, Bakker SJ, van Beek AP. Rationale and design of the CORE (COrticosteroids REvised) study: protocol. BMJ Open. 2022 Apr 26;12(4):e061678. doi: 10.1136/bmjopen-2022-061678.
- Individual participant dataSharing planned: Yes. After deidentification, individual data that are the foundation of the results reported in future manuscripts can be made available (text, tables, figures, and appendices).
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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.
André P. van Beek, MD,PhD principal investigator
University Medical Center Groningen
Stephan J.L. Bakker, MD,PhD principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Prednisolone and Dexamethasone in people with Healthy Volunteers, run by University Medical Center Groningen at 1 site in Netherlands.
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 6 inclusion and 10 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 12 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 Netherlands. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Suzanne P. Stam, MD (0031503617293, s.p.stam@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Suppression of the hypothalamic-pituitary-adrenal axis - low dose (time frame: 1 week per treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04733144, which also lists 1 linked publication.
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 12 Apr 2022.