Prednisolone Urinary Excretion Kinetics

NCT05300490 | Withdrawn

• 1 other identifier: 8328
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Articular Cartilage Disorder of Knee

Keywords

Doping; Prednisolone; Pharmacokinetics; Pharmacogenetics

Outcome Measures

Primary Outcomes (7)

• Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times

  Urinary dosing

  Pre-intervention (infiltration)

• Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times

  Urinary dosing

  Hour24 after intervention

• Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times

  Urinary dosing

  Hour48 after intervention

• Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times

  Urinary dosing

  Day7 after intervention

• Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times

  Urinary dosing

  Day14 after intervention

• Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times

  Urinary dosing

  Day28 after intervention

• Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times

  Urinary dosing

  Day42 after intervention

Study Arms (1)

Knee infiltration

Patients requiring prednisolone knee infiltration as part of routine medical management

Drug: Prednisolone

Interventions

Prednisolone DRUG

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.

Also known as: Infiltration

Knee infiltration

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \- Male or female
• 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
• Affiliated to a social health insurance plan
• Able to understand the protocol and give free, informed and written consent

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Laurent MONASSIER

Strasbourg, 67091, France

Location

MeSH Terms

Interventions

Prednisolone

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: March 29, 2022
• Study Start: May 1, 2023
• Primary Completion: November 1, 2023
• Study Completion: January 1, 2024
• Last Updated: March 20, 2024

Record last verified: 2024-03

Locations

FR (1)