Prednisolone Urinary Excretion Kinetics

NCT ID: NCT05300490

Last Updated: 2024-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-31

Study Completion Date

2024-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Articular Cartilage Disorder of Knee

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Knee infiltration

Patients requiring prednisolone knee infiltration as part of routine medical management

Prednisolone

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Infiltration

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Laurent MONASSIER

Strasbourg, , France

Site Status

Countries

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France

Other Identifiers

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8328

Identifier Type: -

Identifier Source: org_study_id

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