Evaluation of FLEXOFYTOL® Versus PLACEBO (COPRA)

Tilman S.A.

Status: Completed

Conditions: Osteoarthritis

Treatments: Other: PLACEBO; Dietary Supplement: FLEXOFYTOL®

Study type: Interventional

Funder types: Industry

Identifiers

NCT02909621

COPRA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 3 patient groups, including a placebo group

Group A

Active Comparator group

Description:

Group A: FLEXOFYTOL® high dosage

Treatment:

Dietary Supplement: FLEXOFYTOL®

Group B

Active Comparator group

Description:

Group B: FLEXOFYTOL® low dosage

Treatment:

Dietary Supplement: FLEXOFYTOL®

Group C

Placebo Comparator group

Description:

Group C: PLACEBO

Treatment:

Other: PLACEBO