Bioequivalence Study of Prednisolone and Dexamethasone

NCT ID: NCT04733144

Last Updated: 2022-04-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-04
• Study Completion Date: 2022-05-31

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Prednisolone-Dexamethasone

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).

Group Type: ACTIVE_COMPARATOR

Prednisolone

Intervention Type: DRUG

7,5 mg prednisolone (low dose) 30 mg prednisolone (high dose)

Dexamethasone

Intervention Type: DRUG

1,125 mg dexamethasone 4,5 mg dexamethasone

Dexamethasone-Prednisolone

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).

Group Type: ACTIVE_COMPARATOR

Prednisolone

Intervention Type: DRUG

7,5 mg prednisolone (low dose) 30 mg prednisolone (high dose)

Dexamethasone

Intervention Type: DRUG

1,125 mg dexamethasone 4,5 mg dexamethasone

Interventions

Prednisolone

7,5 mg prednisolone (low dose) 30 mg prednisolone (high dose)

Intervention Type: DRUG

Dexamethasone

1,125 mg dexamethasone 4,5 mg dexamethasone

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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:

1. Diseases affecting the HPA-axis: e.g. primary and secondary adrenal insufficiency, pituitary tumors, and nightshift workers

2. Diseases affecting the HPG-axis: e.g. Cushing disease.

3. Chronic inflammatory diseases: e.g. rheumatoid arthritis, polymyalgia rheumatic, and asthma

4. Psychiatric diseases

5. 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

A.P. van Beek, MD PhD

Dr. A.P. van Beek, Endocrinologist, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

André P. van Beek, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Stephan J.L. Bakker, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Locations

University Medical Center Groningen

Groningen, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Suzanne P. Stam, MD

Role: CONTACT

s.p.stam@umcg.nl

0031503617293

Facility Contacts

Suzanne P. Stam, MD

Role: primary

s.p.stam@umcg.nl

0031503617293

Annet Vulto, MD

Role: backup

a.vulto@umcg.nl

0031503617293

References

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.

Reference Type: DERIVED

PMID: 35473729 (View on PubMed)

Other Identifiers

2019-004983-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

201900874

Identifier Type: -

Identifier Source: org_study_id