NCT05012033Recruiting
Evaluation of High Dose Prednisolone Pharmacokinetics in the Acute and Chronic Setting
Source: ClinicalTrials.gov · Last updated 27 Mar 2026
Brief summary (registry, in English)
This is a pilot study to investigate serum prednisolone profiles in: * Patients on high doses of prednisolone for any inflammatory disorder, both in the acute and chronic setting. * Patients stepping up from or down to prednisolone therapy in association with a course of high dose methyl-prednisolone or dexamethasone. The study will comprise 3 groups, including those started on high doses of prednisolone acutely in an inpatient or outpatient setting, participants on chronically high doses, and those receiving a several week course of high dose methylprednisolone or dexamethasone. The study aims to measure prednisolone levels at a number of time points to investigate serum profile differences in those receiving prednisolone acutely compared with longer term steroid use. Further samples will be taken to characterise additional metabolic changes.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 120 (estimated)
- First submitted
- 30 Jul 2021
- Start date
- 12 Apr 2023
- Primary completion date
- Dec 2030
- Lead sponsor
- Imperial College London
- NCT number
- NCT05012033
What you commit to
- Study type: Observational
- Planned participants: 120
- From 12 Apr 2023 to the primary completion date, Dec 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Taking supplements or herbal medications that the participant is unwilling or unable to stop prior to and during the study period e.g. St John's Wort (may decrease prednisolone levels), Cat's claw, Echinacea (immunomodulatory properties).
- Currently taking medications that alter CYP3A4 metabolism of glucocorticoids that the participant is unwilling or unable to stop prior to and during the study period e.g. phenytoin, phenobarbital, rifampicin, rifabutin, carbamazepine, primidone, aminogluethimide, itraconazole, ketoconazole, ciclosporin or ritonavir.
Other illness
- Participants with a diagnosis of Type 1 or Type 2 diabetes mellitus.
- History of any medical, psychological or other condition, or use of any medications, including over-the-counter products, which, in the opinion of the investigators, would either interfere with the study or compromise the safety of the participant.
Age
- Pregnancy. Females of child-bearing age will be asked to provide a urine sample for a pregnancy test at each visit.
Other
- Unable to give informed consent.
Who the study is looking for
- Aged 18 - 75 years
- Male or female
- Participants who are otherwise healthy enough to participate, as determined by pre-study medical history
- Participants who are able and willing to give written informed consent to participate in the study
- Group A only: Patients requiring acute (\<5 days) high dose (minimum 30mg) oral prednisolone therapy for antiinflammatory purposes in either an inpatient or outpatient setting.
- Group B only: Minimum of 1 month duration of high dose prednisolone (\>30mg) if in the chronic use group.
- Group C only: Patients started on high dose methylprednisolone (\>3 day course) or prolonged courses of dexamethasone.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Imperial College Healthcare NHS Trust Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.