Evaluation of FLEXOFYTOL® Versus PLACEBO
- Conditions
- Osteoarthritis
- Interventions
- Other: PLACEBODietary Supplement: FLEXOFYTOL®
- Registration Number
- NCT02909621
- Lead Sponsor
- Tilman S.A.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
- Male or female between the age of 45 and 80
- Artialis (study coordinator) or Tilman (Sponsor) 's employees
- Participation to a therapeutic clinical trial in the last 3 months
- Under guardianship or judicial protection
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group C PLACEBO Group C: PLACEBO Group A FLEXOFYTOL® Group A: FLEXOFYTOL® high dosage Group B FLEXOFYTOL® Group B: FLEXOFYTOL® low dosage
- Primary Outcome Measures
Name Time Method Variation of serum levels of sColl2-1 biomarker between T0 and T3 by specific immunoassays (Enzyme-linked Immunosorbent assay, ELISA). 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. 3 months (between T0 and T3 visit)
- Secondary Outcome Measures
Name Time Method 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) Mean knee pain over the last 24 hours using a visual analogue scale (VAS). 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) 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)
Trial Locations
- Locations (1)
University Hospital of Liège (CHU-Liège)-Coordinating Center
🇧🇪Liège, Province Of Liege, Belgium