Clinical trial

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

Name
8328
Description
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.
Trial arms
Trial start
2023-05-01
Estimated PCD
2023-11-01
Trial end
2024-01-01
Status
Withdrawn
Treatment
Prednisolone
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.
Arms:
Knee infiltration
Other names:
Infiltration
Primary endpoint
Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times
Pre-intervention (infiltration)
Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times
Hour24 after intervention
Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times
Hour48 after intervention
Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times
Day7 after intervention
Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times
Day14 after intervention
Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times
Day28 after intervention
Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times
Day42 after intervention
Eligibility criteria
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
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}
Updated at
2024-03-20

1 organization

1 product

1 indication