Evaluation of FLEXOFYTOL® Versus PLACEBO (COPRA)
Primary Purpose
Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
FLEXOFYTOL®
PLACEBO
Sponsored by
About this trial
This is an interventional supportive care trial for Osteoarthritis focused on measuring OsteoArthritis; FLEXOFYTOL®; Curcuma; biomarkers
Eligibility Criteria
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
Sites / Locations
- University Hospital of Liège (CHU-Liège)-Coordinating Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Group A
Group B
Group C
Arm Description
Group A: FLEXOFYTOL® high dosage
Group B: FLEXOFYTOL® low dosage
Group C: PLACEBO
Outcomes
Primary Outcome Measures
Variation of serum levels of sColl2-1 biomarker between T0 and T3 by specific immunoassays (Enzyme-linked Immunosorbent assay, ELISA).
Variation of Global assessment of disease activity by the patient using a Visual analogue scale (VAS) between T0 and T3.
Secondary Outcome Measures
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).
Mean knee pain over the last 24 hours using a visual analogue scale (VAS).
Global assessment of disease activity using a visual analogue scale (VAS).
Evaluation of Incidence of Emergent Adverse Events (AE), drop-outs and safety issues using blood safety analyses on patients with AE (Tolerance).
Count the capsules in investigation kits brought back by the patient.
Dosage by UHPLC-MS/MS and monitoring of curcumin blood level to assess patient compliance.
Evaluation of Patient's satisfaction by Likert scale.
Evaluate the use of rescue treatments i.e. Paracetamol and oral non-steroidal anti-inflammatory drugs (NSAIDs) during the study.
Secondary outcome 8: Knee injury Osteoarthritis Outcome Score (KOOS) index and its subscale scores using a self-administered questionnaire.
Full Information
NCT ID
NCT02909621
First Posted
September 13, 2016
Last Updated
November 2, 2017
Sponsor
Tilman S.A.
Collaborators
Artialis
1. Study Identification
Unique Protocol Identification Number
NCT02909621
Brief Title
Evaluation of FLEXOFYTOL® Versus PLACEBO
Acronym
COPRA
Official Title
Evaluation of Efficacy, Tolerance, and Dose Effects of a Curcuma Extract (FLEXOFYTOL®) Versus PLACEBO in Patients With Knee osteoARthritis (COPRA)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
November 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tilman S.A.
Collaborators
Artialis
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
OsteoArthritis; FLEXOFYTOL®; Curcuma; biomarkers
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Group A: FLEXOFYTOL® high dosage
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Group B: FLEXOFYTOL® low dosage
Arm Title
Group C
Arm Type
Placebo Comparator
Arm Description
Group C: PLACEBO
Intervention Type
Dietary Supplement
Intervention Name(s)
FLEXOFYTOL®
Other Intervention Name(s)
curcuma extract
Intervention Description
The product FLEXOFYTOL® is bio-optimized curcumin.
Intervention Type
Other
Intervention Name(s)
PLACEBO
Primary Outcome Measure Information:
Title
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)
Title
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 Outcome Measure Information:
Title
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)
Title
Mean knee pain over the last 24 hours using a visual analogue scale (VAS).
Time Frame
6 months (between T0 and T6 visit)
Title
Global assessment of disease activity using a visual analogue scale (VAS).
Time Frame
6 months (between T0 and T6 visit)
Title
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)
Title
Count the capsules in investigation kits brought back by the patient.
Time Frame
6 months (between T0 and T6 visit)
Title
Dosage by UHPLC-MS/MS and monitoring of curcumin blood level to assess patient compliance.
Time Frame
6 months (between T0 and T6 visit)
Title
Evaluation of Patient's satisfaction by Likert scale.
Time Frame
6 months (between T0 and T6 visit)
Title
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)
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University Hospital of Liège (CHU-Liège)-Coordinating Center
City
Liège
State/Province
Province Of Liege
ZIP/Postal Code
4000
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31351488
Citation
Henrotin Y, Malaise M, Wittoek R, de Vlam K, Brasseur JP, Luyten FP, Jiangang Q, Van den Berghe M, Uhoda R, Bentin J, De Vroey T, Erpicum L, Donneau AF, Dierckxsens Y. Bio-optimized Curcuma longa extract is efficient on knee osteoarthritis pain: a double-blind multicenter randomized placebo controlled three-arm study. Arthritis Res Ther. 2019 Jul 27;21(1):179. doi: 10.1186/s13075-019-1960-5.
Results Reference
derived
Links:
URL
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4032499/
Description
Decrease of a specific biomarker of collagen degradation in osteoarthritis, Coll2-1, by treatment with highly bioavailable curcumin during an exploratory clinical trial
Learn more about this trial
Evaluation of FLEXOFYTOL® Versus PLACEBO
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