Osteoarthritis
Conditions
Keywords
OsteoArthritis; FLEXOFYTOL®; Curcuma; biomarkers
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.
Interventions
DIETARY_SUPPLEMENTFLEXOFYTOL®
The product FLEXOFYTOL® is bio-optimized curcumin.
OTHERPLACEBO
Sponsors
Artialis
Tilman S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Male or female between the age of 45 and 80
Exclusion criteria
* Artialis (study coordinator) or Tilman (Sponsor) 's employees * Participation to a therapeutic clinical trial in the last 3 months * Under guardianship or judicial protection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) |
| 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) |
| 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) |
| Dosage by UHPLC-MS/MS and monitoring of curcumin blood level to assess patient compliance. | 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) |
Countries
Belgium
Outcome results
None listed