Evaluation of Efficacy, Tolerance, and Dose Effects of a Curcuma Extract (FLEXOFYTOL®) Versus PLACEBO in Patients With Knee osteoARthritis (COPRA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Variation of serum levels of sColl2-1 biomarker between T0 and T3 by specific immunoassays (Enzyme-linked Immunosorbent assay, ELISA).
研究概览
简要总结
This study is a prospective, randomized, double-blind, placebo-controlled with 3 parallel-groups and multicenter trial in patients suffering from knee OA (osteoarthrosis).
A first exploratory non comparative study (TILFLEXY002, NCT01909037, Henrotin et al., 2014 BMC Complementary and Alternative Medicine) evaluated the efficacy of FLEXOFYTOL® at the dose of 2x3 caps/day, during a 3-month period, in 22 patients suffering from knee OA, on the serum levels of cartilage-specific and inflammatory biomarkers, on the evaluation of pain and on the global patient assessment of disease activity.
This study demonstrated a statistically significant decrease of sColl2-1 cartilage specific biomarker, an early decrease of the ultrasensitive C-reactive protein (CRP), an improvement of the global assessment of the disease by the patient as well as a good tolerance and compliance for the treatment. Results of this exploratory study are encouraging and justify the setup of a randomized, placebo-controlled double blind and dose-ranging trial.
详细描述
150 patients suffering from symptomatic knee OA will be randomized in 3 parallel groups (50 patients per group). Each patient will be enrolled in the study for 6 months including 4 visits: Inclusion visit (T0), follow-up visits after 1 month (T1), 3 months (T3) and 6 months (T6).
A. Primary objective
- Evaluate the efficacy of two different dosages of FLEXOFYTOL® versus PLACEBO on arthritis related biomarker coll2-1 and on patient assessment of disease activity in patients suffering from knee OA after a 3 months treatment
B. Secondary objectives
- Evaluate the efficacy of two different dosages of FLEXOFYTOL® versus PLACEBO on arthritis-related and inflammatory biomarkers.
- Evaluate the efficacy of two different dosages of FL EXOFYTOL® versus PLACEBO on pain and function.
- Evaluate the tolerance, the compliance and the patients' satisfaction.
- Evaluate the use of rescue treatments i.e. Paracetamol and oral non-steroidal antiinflammatory drugs (NSAIDs) during the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female between the age of 45 and 80
排除标准
- •Artialis (study coordinator) or Tilman (Sponsor) 's employees
- •Participation to a therapeutic clinical trial in the last 3 months
- •Under guardianship or judicial protection
研究组 & 干预措施
Group C
Group C: PLACEBO
干预措施: PLACEBO (Other)
Group A
Group A: FLEXOFYTOL® high dosage
干预措施: FLEXOFYTOL® (Dietary Supplement)
Group B
Group B: FLEXOFYTOL® low dosage
干预措施: FLEXOFYTOL® (Dietary Supplement)
结局指标
主要结局
Variation of serum levels of sColl2-1 biomarker between T0 and T3 by specific immunoassays (Enzyme-linked Immunosorbent assay, ELISA).
时间窗: 3 months (between T0 and T3 visit)
Variation of Global assessment of disease activity by the patient using a Visual analogue scale (VAS) between T0 and T3.
时间窗: 3 months (between T0 and T3 visit)
次要结局
- Variation of serum levels of sColl2-1 (type II collagen degradation) and ultrasensitive CRP (C-reactive protein) biomarkers by specific immunoassays (Enzyme-linked Immunosorbent assay, ELISA).(6 months (between T0 and T6 visit))
- Global assessment of disease activity using a visual analogue scale (VAS).(6 months (between T0 and T6 visit))
- Mean knee pain over the last 24 hours using a visual analogue scale (VAS).(6 months (between T0 and T6 visit))
- Evaluation of Incidence of Emergent Adverse Events (AE), drop-outs and safety issues using blood safety analyses on patients with AE (Tolerance).(6 months (between T0 and T6 visit))
- Count the capsules in investigation kits brought back by the patient.(6 months (between T0 and T6 visit))
- Dosage by UHPLC-MS/MS and monitoring of curcumin blood level to assess patient compliance.(6 months (between T0 and T6 visit))
- Evaluation of Patient's satisfaction by Likert scale.(6 months (between T0 and T6 visit))
- Evaluate the use of rescue treatments i.e. Paracetamol and oral non-steroidal anti-inflammatory drugs (NSAIDs) during the study.(6 months (between T0 and T6 visit))
- Secondary outcome 8: Knee injury Osteoarthritis Outcome Score (KOOS) index and its subscale scores using a self-administered questionnaire.(6 months (between T0 and T6 visit))