NCT02909621

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Tilman S.A. · Industry
• Sex: All
• Age: 45 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	FLEXOFYTOL®	The product FLEXOFYTOL® is bio-optimized curcumin.
OTHER	PLACEBO

Timeline

• Start date: 2014-05-01
• Primary completion: 2017-07-01
• Completion: 2017-11-01
• First posted: 2016-09-21
• Last updated: 2017-11-06

Locations

1 site across 1 country: Belgium