URIPRED: Prednisolone Urinary Excretion Kinetics

Sponsor
University Hospital, Strasbourg, France (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05300490
Collaborator
(none)
45
14

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Anticipated Enrollment :
45 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Pilot Study of the Urinary Elimination Kinetics of Prednisolone After Intra-articular Injection in the Knee
Anticipated Study Start Date :
Mar 1, 2022
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Knee infiltration

Patients requiring prednisolone knee infiltration as part of routine medical management

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.
Other Names:
  • Infiltration
  • Outcome Measures

    Primary Outcome Measures

    1. Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times [Pre-intervention (infiltration)]

      Urinary dosing

    2. Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times [Hour24 after intervention]

      Urinary dosing

    3. Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times [Hour48 after intervention]

      Urinary dosing

    4. Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times [Day7 after intervention]

      Urinary dosing

    5. Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times [Day14 after intervention]

      Urinary dosing

    6. Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times [Day28 after intervention]

      Urinary dosing

    7. Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times [Day42 after intervention]

      Urinary dosing

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University Hospital, Strasbourg, France

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Strasbourg, France
    ClinicalTrials.gov Identifier:
    NCT05300490
    Other Study ID Numbers:
    • 8328
    First Posted:
    Mar 29, 2022
    Last Update Posted:
    Mar 29, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Strasbourg, France
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 29, 2022