Evaluation of FLEXOFYTOL® Versus PLACEBO

Osteoarthritis Clinical Trial

— COPRA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02909621
• Other study ID #: COPRA
• Status: Completed
• Phase: N/A
• First received: September 13, 2016
• Last updated: November 2, 2017
• Start date: May 2014
• Est. completion date: November 2017

Study information

• Verified date: November 2017
• Source: Tilman S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: November 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Dietary Supplement:
• FLEXOFYTOL®
The product FLEXOFYTOL® is bio-optimized curcumin.

Other:
• PLACEBO

Locations

Country	Name	City	State
Belgium	University Hospital of Liège (CHU-Liège)-Coordinating Center	Liège	Province Of Liege

Sponsors (2)

Lead Sponsor	Collaborator
Tilman S.A.	Artialis

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	Mean knee pain over the last 24 hours using a visual analogue scale (VAS).		6 months (between T0 and T6 visit)
Secondary	Global assessment of disease activity using a visual analogue scale (VAS).		6 months (between T0 and T6 visit)
Secondary	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)
Secondary	Count the capsules in investigation kits brought back by the patient.		6 months (between T0 and T6 visit)
Secondary	Dosage by UHPLC-MS/MS and monitoring of curcumin blood level to assess patient compliance.		6 months (between T0 and T6 visit)
Secondary	Evaluation of Patient's satisfaction by Likert scale.		6 months (between T0 and T6 visit)
Secondary	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	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)

External Links

•   Decrease of a specific biomarker of collagen degradation in osteoarthritis, Coll2-1, by treatment with highly bioavailable curcumin during an exploratory clinical trial