SporTRIA Study: A Multicentre Trial for Excretion Kinetics of Triamcinolone Acetonide Following Sport Related Intra-articular Injections in Knees; Definitions of the Washout Periods
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Determination of the excretion profile of triamcinolone acetonide in urine following intra-articular ultrasound-guided injection
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
athletic subjects
athletic subjects who may need intra-articular knee infiltration
干预措施: knee intra-articular infiltration with Triamcinolone acetonide (Drug)
结局指标
主要结局
Determination of the excretion profile of triamcinolone acetonide in urine following intra-articular ultrasound-guided injection
时间窗: 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)
次要结局
- Modeling of the excretion profile of triamcinolone acetonide in urine following intra-articular ultrasound-guided injection.(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(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.(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 glucocorticoids blood value from baseline, pre-injection (day 0) to Day 35)
- Determination of cortisol levels in DBS to evaluate systemic effect(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.(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.(Change from baseline, pre-injection (day 0) glucocorticoids DBS value up to 35 days)
研究者
Edem ALLADO
Doctor
Central Hospital, Nancy, France