Articular Cartilage Disorder of KneeURIPREDNCT05300490
Prednisolone Urinary Excretion Kinetics
An observational study of Articular Cartilage Disorder of Knee, run by University Hospital, Strasbourg, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Articular Cartilage Disorder of Knee
- What is being tested?
- Prednisolone
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- May 2023to 1 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient consulting the rheumatology department of the university hospital of Strasbourg (France) for a knee pathology requiring a glucocorticoid infiltration.
Who may be able to join
- - 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
Who cannot join
- NA
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of the Urinary Elimination Kinetics of Prednisolone After Intra-articular Injection in the Knee
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
- Being tested
- Prednisolone
- Keywords
- Doping, Prednisolone, Pharmacokinetics, Pharmacogenetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoloneDrug
Also called Infiltration
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.
| Study group | Role | What they receive |
|---|---|---|
| Knee infiltration | Patients requiring prednisolone knee infiltration as part of routine medical management Receives: Drug: Prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times
Urinary dosing
Measured: Pre-intervention (infiltration)
Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times
Urinary dosing
Measured: Hour24 after intervention
Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times
Urinary dosing
Measured: Hour48 after intervention
Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times
Urinary dosing
Measured: Day7 after intervention
Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times
Urinary dosing
Measured: Day14 after intervention
Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times
Urinary dosing
Measured: Day28 after intervention
Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times
Urinary dosing
Measured: Day42 after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study startMay 2023 (estimated)
- Primary completionNov 2023 (estimated)
- Study completion1 Jan 2024
Why it stopped: As practices had changed by the time this trial was being set up, there was no inclusion in this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Articular Cartilage Disorder of KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05300490
- Sponsor's protocol ID
- 8328
- Acronym
- URIPRED
- Status last verified
- Mar 2024
- First submitted
- 15 Feb 2022
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Urinary Elimination Kinetics of Prednisolone After Intra-articular Injection in the Knee
- ClinicalTrials.gov ID
- NCT05300490
- Acronym / sponsor ID
- URIPRED / 8328
- Conditions
- Articular Cartilage Disorder of Knee
- Keywords
- Doping, Prednisolone, Pharmacokinetics, Pharmacogenetics
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: As practices had changed by the time this trial was being set up, there was no inclusion in this study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- May 2023 (estimated)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 29 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Knee infiltration | – | Drug: PrednisolonePatients requiring prednisolone knee infiltration as part of routine medical management |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient consulting the rheumatology department of the university hospital of Strasbourg (France) for a knee pathology requiring a glucocorticoid infiltration.
Key inclusion criteria (8 listed)
- - 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
Key exclusion criteria (1 listed)
- NA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrednisoloneAlso: InfiltrationIn 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. | Drug | Knee infiltration |
Primary outcome
Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times
Time frame: Pre-intervention (infiltration)
Urinary dosing
Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times
Time frame: Hour24 after intervention
Urinary dosing
Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times
Time frame: Hour48 after intervention
Urinary dosing
Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times
Time frame: Day7 after intervention
Urinary dosing
Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times
Time frame: Day14 after intervention
Urinary dosing
Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times
Time frame: Day28 after intervention
Urinary dosing
Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times
Time frame: Day42 after intervention
Urinary dosing
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
Related trials for Articular Cartilage Disorder of Knee
RecruitingPhase 3
Phase 3 Pivotal Trial Comparing CARTISTEM® and Surgical Comparator for Knee Cartilage Lesions and Osteoarthritis
Knee Cartilage Defects
Recruiting
Autologous Adipose-Derived Stem Cell Injections for Knee Osteoarthritis
Osteoarthritis, Knee
RecruitingObservational study
Cartilage Biomarker Response to Acute Mechanical Loading in Women With Knee Osteoarthritis: Comparison by Antiresorptive Treatment Status
Knee Osteoarthritis
Recruiting
Subchondral Drilling Diameter During CARTISTEM Implantation for Knee Cartilage Defects
Osteoarthritis, Knee, Articular Cartilage Defects of the Knee
RecruitingPhase 3
A Study of MACI in Patients Aged 10 to 17 Years With Symptomatic Chondral or Osteochondral Defects of the Knee
Chondral Defect, Osteochondritis Dissecans (OCD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Articular Cartilage Disorder of Knee, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative urinary determination (presence or absence) by LC-MS/MS of the prednisolone/prednisone ratio at specific times (time frame: Pre-intervention (infiltration)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.