Trial | NCT02909621  Report issue

Title

Evaluation of FLEXOFYTOL® Versus PLACEBO
Evaluation of Efficacy, Tolerance, and Dose Effects of a Curcuma Extract (FLEXOFYTOL®) Versus PLACEBO in Patients With Knee osteoARthritis (COPRA)

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    curcumin ...

  • Study Participants

    150
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.
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.
Study Started
May 31
2014
Primary Completion
Jul 31
2017
Study Completion
Nov 30
2017
Last Update
Nov 06
2017

Dietary Supplement FLEXOFYTOL®

The product FLEXOFYTOL® is bio-optimized curcumin.

  • Other names: curcuma extract

Other PLACEBO

Group A Active Comparator

Group A: FLEXOFYTOL® high dosage

Group B Active Comparator

Group B: FLEXOFYTOL® low dosage

Group C Placebo Comparator

Group C: PLACEBO

Criteria 

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
No Results Posted