Doping in SportSporTRIANCT04574232
SporTRIA Study: A Multicentre Trial for Excretion Kinetics of Triamcinolone Acetonide Following Sport Related Intra-articular Injections in Knees; Definitions of the Washout Periods
A study testing knee intra-articular infiltration with Triamcinolone acetonide in people with Doping in Sport and Glucocorticoids, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Intra-articular and peri-articular glucocorticoid (GC) injections are common in sports medicine. However, from 1st January 2022, all injectable GC routes (including intra-articular administration (IA)) will be prohibited in-competition by World Anti-Doping Agency (WADA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Doping in Sport, Glucocorticoids
- What is being tested?
- knee intra-articular infiltration with Triamcinolone acetonide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2023to 1 Dec 2024
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sports practice at least 4h / week
- No comorbidities against indicating intra-articular knee injection
- Subject with a knee disease requiring intra-articular injection of GCs
Who cannot join
- Subject with glucocorticoid (GC) allergy or GC medical contraindication
- Pregnant women or women of childbearing potential without effective contraception
- Washout period of all injectable routes and systemic use of GCs less than 3 months
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Régional Universitaire de Nancy.
Vandœuvre-lès-Nancy, 54500
Edem ALLADO, MD MSc, +33383858585, e.allado@chru-nancy.fr
Edem ALLADO, MD PhD
About this study
Intra-articular and peri-articular glucocorticoid (GC) injections are common in sports medicine. However, from 1st January 2022, all injectable GC routes (including intra-articular administration (IA)) will be prohibited in-competition by World Anti-Doping Agency (WADA). Due to these rules, an IA GC treatment out-of-competition could result in an adverse analytical finding (AAF) in-competition if the washout period is not clearly defined. The aim of this study is to determine the urinary excretion profile of triamcinolone acetonide following IA to help in the definition of the washout periods.
- Conditions
- Doping in Sport, Glucocorticoids
- Being tested
- knee intra-articular infiltration with Triamcinolone acetonide
- Keywords
- glucocordicoids, Doping, sport, urinary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
knee intra-articular infiltration with Triamcinolone acetonideDrug
knee intra-articular intra-articular ultrasound-guided infiltration of Triamcinolone acetonide
| Study group | Role | What they receive |
|---|---|---|
| athletic subjects | Other | athletic subjects who may need intra-articular knee infiltration Receives: Drug: knee intra-articular infiltration with Triamcinolone acetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the excretion profile of triamcinolone acetonide in urine following intra-articular ultrasound-guided injection
For subjects with a glucocorticoids urinary value below the 15 ng/ml threshold at D0 (before injection), identification of the date (up to 35 days) following the intra-articular ultrasound-guided injection which will correspond in the standards of the World Agency (under 15 ng/ml)
Measured: Change from baseline, pre-injection (day 0) to date (up to 35 days) where glucocorticoids urinary value below the 15 ng/ml
Secondary outcomes (7)
Modeling of the excretion profile of triamcinolone acetonide in urine following intra-articular ultrasound-guided injection.
Evolution of urinary triamcinolone acetonide concentration
Measured: evolution glucocorticoids urinary value from baseline, pre-injection (day 0) to Day 35
Determination of the excretion profile of cortisol in urine following intra-articular ultrasound-guided injection to evaluate systemic effect
Measured: Change from baseline, pre-injection (day 0) glucocorticoids urinary value up to 35 days
Determination of the excretion profile of triamcinolone acetonide in DBS anti-doping test following intra-articular ultrasound-guided injection.
Measured: Change from baseline, pre-injection (day 0) glucocorticoids DBS value up to 35 days
Modeling of the excretion profile of triamcinolone acetonide in DBS anti-doping test following intra-articular ultrasound-guided injection.
Evolution of blood triamcinolone acetonide concentration
Measured: evolution glucocorticoids blood value from baseline, pre-injection (day 0) to Day 35
Determination of cortisol levels in DBS to evaluate systemic effect
Measured: Change from baseline, pre-injection (day 0) glucocorticoids DBS value up to 35 days
Identification of GCs on hair mark presence one month after intra-articular ultrasound-guided injection of triamcinolone acetonide.
Measured: Change from baseline, pre-injection (day 0) glucocorticoids hair value up to 35 days
Evaluation of the impact of exogenous corticosteroids on endogenous steroids profile (androgens and GCs) in DBS samples.
Mesure of blood exogenous corticosteroids on endogenous steroidsconcentration
Measured: Change from baseline, pre-injection (day 0) glucocorticoids DBS value up to 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start1 Jan 2023
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Doping in SportStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edem ALLADO, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04574232
- Sponsor's protocol ID
- 2020-A01448-31
- Acronym
- SporTRIA
- Status last verified
- Feb 2023
- First submitted
- 18 Sep 2020
- Last updated
- 27 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data from all patients will be centrally stored in Nancy. Data management will be carried out by CHRU de Nancy (Direction de la Recherche et de l'Innovation). The conditions for data transfer of all or part of the study database are decided by the study sponsor and are the subject of a written contract. This study and the data collected fall within the scope of Reference Methodology MR001. The data may be transmitted to the companies in the group to which the promoter belongs and to its contractual partners in a form which should not permit the direct or indirect identification of persons lending themselves to research
Publications
Allado E, Poussel M, Gambier N, Saunier V, Starck M, Buisson C, Cinquetti G, Albuisson E, Chenuel B. SporTRIA study-a multicentre trial protocol for excretion kinetics of triamcinolone acetonide following sport-related intra-articular injections in knees: definitions of the washout periods. BMJ Open. 2021 Jun 9;11(6):e047548. doi: 10.1136/bmjopen-2020-047548.
PubMed 34108168
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SporTRIA Study: A Multicentre Trial for Excretion Kinetics of Triamcinolone Acetonide Following Sport Related Intra-articular Injections in Knees; Definitions of the Washout Periods
- ClinicalTrials.gov ID
- NCT04574232
- Acronym / sponsor ID
- SporTRIA / 2020-A01448-31
- Conditions
- Doping in Sport, Glucocorticoids
- Keywords
- glucocordicoids, Doping, sport, urinary
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 5 Oct 2020 (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.
Intra-articular and peri-articular glucocorticoid (GC) injections are common in sports medicine. However, from 1st January 2022, all injectable GC routes (including intra-articular administration (IA)) will be prohibited in-competition by World Anti-Doping Agency (WADA). Due to these rules, an IA GC treatment out-of-competition could result in an adverse analytical finding (AAF) in-competition if the washout period is not clearly defined. The aim of this study is to determine the urinary excretion profile of triamcinolone acetonide following IA to help in the definition of the washout periods.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| athletic subjects | Other | Drug: knee intra-articular infiltration with Triamcinolone acetonideathletic subjects who may need intra-articular knee infiltration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Sports practice at least 4h / week
- No comorbidities against indicating intra-articular knee injection
- Subject with a knee disease requiring intra-articular injection of GCs
Key exclusion criteria (3 listed)
- Subject with glucocorticoid (GC) allergy or GC medical contraindication
- Pregnant women or women of childbearing potential without effective contraception
- Washout period of all injectable routes and systemic use of GCs less than 3 months
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 |
|---|---|---|
| knee intra-articular infiltration with Triamcinolone acetonideknee intra-articular intra-articular ultrasound-guided infiltration of Triamcinolone acetonide | Drug | athletic subjects |
Primary outcome
Determination of the excretion profile of triamcinolone acetonide in urine following intra-articular ultrasound-guided injection
Time frame: Change from baseline, pre-injection (day 0) to date (up to 35 days) where glucocorticoids urinary value below the 15 ng/ml
For subjects with a glucocorticoids urinary value below the 15 ng/ml threshold at D0 (before injection), identification of the date (up to 35 days) following the intra-articular ultrasound-guided injection which will correspond in the standards of the World Agency (under 15 ng/ml)
7 secondary outcomes
Modeling of the excretion profile of triamcinolone acetonide in urine following intra-articular ultrasound-guided injection.
Time frame: evolution glucocorticoids urinary value from baseline, pre-injection (day 0) to Day 35
Determination of the excretion profile of cortisol in urine following intra-articular ultrasound-guided injection to evaluate systemic effect
Time frame: Change from baseline, pre-injection (day 0) glucocorticoids urinary value up to 35 days
Determination of the excretion profile of triamcinolone acetonide in DBS anti-doping test following intra-articular ultrasound-guided injection.
Time frame: Change from baseline, pre-injection (day 0) glucocorticoids DBS value up to 35 days
Modeling of the excretion profile of triamcinolone acetonide in DBS anti-doping test following intra-articular ultrasound-guided injection.
Time frame: evolution glucocorticoids blood value from baseline, pre-injection (day 0) to Day 35
Determination of cortisol levels in DBS to evaluate systemic effect
Time frame: Change from baseline, pre-injection (day 0) glucocorticoids DBS value up to 35 days
Identification of GCs on hair mark presence one month after intra-articular ultrasound-guided injection of triamcinolone acetonide.
Time frame: Change from baseline, pre-injection (day 0) glucocorticoids hair value up to 35 days
Evaluation of the impact of exogenous corticosteroids on endogenous steroids profile (androgens and GCs) in DBS samples.
Time frame: Change from baseline, pre-injection (day 0) glucocorticoids DBS value up to 35 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2023.
- Derived from this study: PubMed 34108168Allado E, Poussel M, Gambier N, Saunier V, Starck M, Buisson C, Cinquetti G, Albuisson E, Chenuel B. SporTRIA study-a multicentre trial protocol for excretion kinetics of triamcinolone acetonide following sport-related intra-articular injections in knees: definitions of the washout periods. BMJ Open. 2021 Jun 9;11(6):e047548. doi: 10.1136/bmjopen-2020-047548.
- Individual participant dataSharing planned: Yes. The data from all patients will be centrally stored in Nancy. Data management will be carried out by CHRU de Nancy (Direction de la Recherche et de l'Innovation). The conditions for data transfer of all or part of the study database are decided by the study sponsor and are the subject of a written contract. This study and the data collected fall within the scope of Reference Methodology MR001. The data may be transmitted to the companies in the group to which the promoter belongs and to its contractual partners in a form which should not permit the direct or indirect identification of persons lending themselves to research
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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.
Centre Hospitalier Régional Universitaire de Nancy.
Vandœuvre-lès-Nancy, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing knee intra-articular infiltration with Triamcinolone acetonide in people with Doping in Sport and Glucocorticoids, run by Central Hospital, Nancy, 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 27 Feb 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of the excretion profile of triamcinolone acetonide in urine following intra-articular ultrasound-guided injection (time frame: Change from baseline, pre-injection (day 0) to date (up to 35 days) where glucocorticoids urinary value below the 15 ng/ml). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04574232, which also lists 1 linked publication.
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 27 Feb 2023.