Prednisolone Urinary Excretion Kinetics

Articular Cartilage Disorder of Knee Clinical Trial

— URIPRED  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05300490
• Other study ID #: 8328
• Status: Withdrawn
• Start date: May 2023
• Est. completion date: January 1, 2024

Study information

• Verified date: March 2024
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 1, 2024
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Articular Cartilage Disorder of Knee
• Cartilage Diseases

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
France	Laurent MONASSIER	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times	Urinary dosing	Pre-intervention (infiltration)
Primary	Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times	Urinary dosing	Hour24 after intervention
Primary	Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times	Urinary dosing	Hour48 after intervention
Primary	Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times	Urinary dosing	Day7 after intervention
Primary	Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times	Urinary dosing	Day14 after intervention
Primary	Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times	Urinary dosing	Day28 after intervention
Primary	Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times	Urinary dosing	Day42 after intervention