Clinical trial NCT05300490: Prednisolone Urinary Excretion Kinetics
Official title: A Pilot Study of the Urinary Elimination Kinetics of Prednisolone After Intra-articular Injection in the Knee
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Articular Cartilage Disorder of Knee
Keywords: Doping
Prednisolone
Pharmacokinetics
Pharmacogenetics
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2022-03-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient consulting the rheumatology department of the university hospital of Strasbourg (France) for a knee pathology requiring a glucocorticoid infiltration.

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.


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

Primary outcomes:
measure: Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times
timeFrame: Pre-intervention (infiltration)
measure: Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times
timeFrame: Hour24 after intervention
measure: Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times
timeFrame: Hour48 after intervention
measure: Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times
timeFrame: Day7 after intervention
measure: Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times
timeFrame: Day14 after intervention
measure: Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times
timeFrame: Day28 after intervention
measure: Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times
timeFrame: Day42 after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Laurent MONASSIER
Study officials:
References: