NCT05012033 Evaluation of High Dose Prednisolone Pharmacokinetics in the Acute and Chronic Setting
| NCT ID | NCT05012033 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Imperial College London |
| Condition | Thyroid Eye Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2023-04-12 |
| Primary Completion | 2030-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2023-04-12 with a primary completion date of 2030-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Participants with a diagnosis of Type 1 or Type 2 diabetes mellitus. * Unable to give informed consent. * 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. * Pregnancy. Females of child-bearing age will be asked to provide a urine sample for a pregnancy test at each visit. * 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.
Contact & Investigator
Karim Meeran, MBBS BSc MD
PRINCIPAL INVESTIGATOR
Imperial College London
Frequently Asked Questions
Who can join the NCT05012033 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Thyroid Eye Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05012033 currently recruiting?
Yes, NCT05012033 is actively recruiting participants. Contact the research team at imperial.steroids@nhs.net for enrollment information.
Where is the NCT05012033 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT05012033 clinical trial?
NCT05012033 is sponsored by Imperial College London. The principal investigator is Karim Meeran, MBBS BSc MD at Imperial College London. The trial plans to enroll 120 participants.