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Prednisolone Urinary Excretion Kinetics

A Pilot Study of the Urinary Elimination Kinetics of Prednisolone After Intra-articular Injection in the Knee

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05300490
Acronym
URIPRED
Enrollment
0
Registered
2022-03-29
Start date
2023-05-31
Completion date
2024-01-01
Last updated
2024-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Articular Cartilage Disorder of Knee

Keywords

Doping, Prednisolone, Pharmacokinetics, Pharmacogenetics

Brief summary

The urinary elimination kinetics of glucocorticoids after intra-articular injection is very poorly documented. It is estimated that glucocorticoids may be present in the urine up to 6 weeks after intra-articular injection. However, this is not supported by any scientific literature. Despite this lack of evidence, in doping control practice, any presence of glucocorticoids in urine is accepted when the athlete provides evidence of an intra-articular injection that took place less than 6 weeks prior to the doping control. Many doping cases are open to challenge because they are based solely on measurements of prednisolone concentrations and its blood esterase product, prednisone. In order to demonstrate the use of prednisolone for doping purposes (systemic and not intra-articular use), it is therefore necessary to know the urinary elimination kinetics of prednisolone and prednisone, as well as the evolution of the concentration ratio between these 2 molecules.

Interventions

DRUGPrednisolone

In this routine care study, all patients will receive a joint injection of prednisolone at a dose left to the discretion of the physician. The urinary excretion kinetics of this product and its metabolites will then be followed at different times. An association with metabolic genetic profile will be done.

Sponsors

University Hospital, Strasbourg, France
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* \- Male or female * 18-65 years old * requiring intra-articular injection of prednisolone as part of routine care * naive to any corticosteroid administration * requiring a blood biology test as part of routine care and before the infiltration procedure * For women of childbearing age, negative urine pregnancy test at inclusion * Affiliated to a social health insurance plan * Able to understand the protocol and give free, informed and written consent

Exclusion criteria

* NA

Design outcomes

Primary

MeasureTime frameDescription
Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific timesPre-intervention (infiltration)Urinary dosing

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026