- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02909621
Evaluation of FLEXOFYTOL® Versus PLACEBO (COPRA)
Evaluation of Efficacy, Tolerance, and Dose Effects of a Curcuma Extract (FLEXOFYTOL®) Versus PLACEBO in Patients With Knee osteoARthritis (COPRA)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Province Of Liege
-
Liège, Province Of Liege, Belgium, 4000
- University Hospital of Liège (CHU-Liège)-Coordinating Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group A
Group A: FLEXOFYTOL® high dosage
|
The product FLEXOFYTOL® is bio-optimized curcumin.
Other Names:
|
Active Comparator: Group B
Group B: FLEXOFYTOL® low dosage
|
The product FLEXOFYTOL® is bio-optimized curcumin.
Other Names:
|
Placebo Comparator: Group C
Group C: PLACEBO
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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)
|
3 months (between T0 and T3 visit)
|
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)
|
3 months (between T0 and T3 visit)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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)
|
6 months (between T0 and T6 visit)
|
Mean knee pain over the last 24 hours using a visual analogue scale (VAS).
Time Frame: 6 months (between T0 and T6 visit)
|
6 months (between T0 and T6 visit)
|
Global assessment of disease activity using a visual analogue scale (VAS).
Time Frame: 6 months (between T0 and T6 visit)
|
6 months (between T0 and T6 visit)
|
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)
|
6 months (between T0 and T6 visit)
|
Count the capsules in investigation kits brought back by the patient.
Time Frame: 6 months (between T0 and T6 visit)
|
6 months (between T0 and T6 visit)
|
Dosage by UHPLC-MS/MS and monitoring of curcumin blood level to assess patient compliance.
Time Frame: 6 months (between T0 and T6 visit)
|
6 months (between T0 and T6 visit)
|
Evaluation of Patient's satisfaction by Likert scale.
Time Frame: 6 months (between T0 and T6 visit)
|
6 months (between T0 and T6 visit)
|
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)
|
6 months (between T0 and T6 visit)
|
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)
|
6 months (between T0 and T6 visit)
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- COPRA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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