Trials / Withdrawn
WithdrawnNCT05300490
Prednisolone Urinary Excretion Kinetics
A Pilot Study of the Urinary Elimination Kinetics of Prednisolone After Intra-articular Injection in the Knee
- Status
- Withdrawn
- Phase
- —
- Study type
- Observational
- Enrollment
- 0 (actual)
- Sponsor
- University Hospital, Strasbourg, France · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2023-05-01
- Primary completion
- 2023-11-01
- Completion
- 2024-01-01
- First posted
- 2022-03-29
- Last updated
- 2024-03-20
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT05300490. Inclusion in this directory is not an endorsement.