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NCT Number: NCT02909621

Evaluation of FLEXOFYTOL® Versus PLACEBO

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.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Liège (CHU-Liège)-Coordinating Center

Liège, Province of Liege, 4000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FLEXOFYTOL®

Dietary Supplement

The product FLEXOFYTOL® is bio-optimized curcumin.

Other names: curcuma extract

Placebo

Other

Primary outcomes

  1. Variation of serum levels of sColl2-1 biomarker between T0 and T3 by specific immunoassays (Enzyme-linked Immunosorbent assay, ELISA).

    Time frame: 3 months (between T0 and T3 visit)

  2. Variation of Global assessment of disease activity by the patient using a Visual analogue scale (VAS) between T0 and T3.

    Time frame: 3 months (between T0 and T3 visit)

Secondary outcomes

  1. 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).

    Time frame: 6 months (between T0 and T6 visit)

  2. Mean knee pain over the last 24 hours using a visual analogue scale (VAS).

    Time frame: 6 months (between T0 and T6 visit)

  3. Global assessment of disease activity using a visual analogue scale (VAS).

    Time frame: 6 months (between T0 and T6 visit)

  4. Evaluation of Incidence of Emergent Adverse Events (AE), drop-outs and safety issues using blood safety analyses on patients with AE (Tolerance).

    Time frame: 6 months (between T0 and T6 visit)

  5. Count the capsules in investigation kits brought back by the patient.

    Time frame: 6 months (between T0 and T6 visit)

  6. Dosage by UHPLC-MS/MS and monitoring of curcumin blood level to assess patient compliance.

    Time frame: 6 months (between T0 and T6 visit)

  7. Evaluation of Patient's satisfaction by Likert scale.

    Time frame: 6 months (between T0 and T6 visit)

  8. Evaluate the use of rescue treatments i.e. Paracetamol and oral non-steroidal anti-inflammatory drugs (NSAIDs) during the study.

    Time frame: 6 months (between T0 and T6 visit)

  9. Secondary outcome 8: Knee injury Osteoarthritis Outcome Score (KOOS) index and its subscale scores using a self-administered questionnaire.

    Time frame: 6 months (between T0 and T6 visit)

Sponsors and collaborators

Lead sponsor

Tilman S.A.

Industry

Collaborators

  • Artialis

Registry information

Official study title

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

Acronym: COPRA

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Sep 21, 2016
Registry last updated
Nov 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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