OsteoarthritisCOPRANCT02909621
Evaluation of FLEXOFYTOL® Versus PLACEBO
A study testing FLEXOFYTOL® in people with Osteoarthritis, run by Tilman S.A. at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- FLEXOFYTOL®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteBelgium
- Study dates
- May 2014to Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female between the age of 45 and 80
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Belgium1 site
University Hospital of Liège (CHU-Liège)-Coordinating Center
Liège, Province of Liege, 4000
About this study
Official title: 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.
Read the 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).
- 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
- 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
- Being tested
- FLEXOFYTOL®, PLACEBO
- Keywords
- OsteoArthritis; FLEXOFYTOL®; Curcuma; biomarkers
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLEXOFYTOL®Dietary supplement
Also called curcuma extract
The product FLEXOFYTOL® is bio-optimized curcumin.
PLACEBOOther
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Group A: FLEXOFYTOL® high dosage Receives: Dietary Supplement: FLEXOFYTOL® |
| Group B | Active comparator | Group B: FLEXOFYTOL® low dosage Receives: Dietary Supplement: FLEXOFYTOL® |
| Group C | Placebo comparator | Group C: PLACEBO Receives: Other: PLACEBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of serum levels of sColl2-1 biomarker between T0 and T3 by specific immunoassays (Enzyme-linked Immunosorbent assay, ELISA).
Measured: 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.
Measured: 3 months (between T0 and T3 visit)
Secondary outcomes (9)
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).
Measured: 6 months (between T0 and T6 visit)
Mean knee pain over the last 24 hours using a visual analogue scale (VAS).
Measured: 6 months (between T0 and T6 visit)
Global assessment of disease activity using a visual analogue scale (VAS).
Measured: 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).
Measured: 6 months (between T0 and T6 visit)
Count the capsules in investigation kits brought back by the patient.
Measured: 6 months (between T0 and T6 visit)
Dosage by UHPLC-MS/MS and monitoring of curcumin blood level to assess patient compliance.
Measured: 6 months (between T0 and T6 visit)
Evaluation of Patient's satisfaction by Likert scale.
Measured: 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.
Measured: 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.
Measured: 6 months (between T0 and T6 visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study startMay 2014
- Primary completionJul 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tilman S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Artialis
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02909621
- Sponsor's protocol ID
- COPRA
- Acronym
- COPRA
- Status last verified
- Nov 2017
- First submitted
- 13 Sep 2016
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 31351488
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy, Tolerance, and Dose Effects of a Curcuma Extract (FLEXOFYTOL®) Versus PLACEBO in Patients With Knee osteoARthritis (COPRA)
- ClinicalTrials.gov ID
- NCT02909621
- Acronym / sponsor ID
- COPRA / COPRA
- Conditions
- Osteoarthritis
- Keywords
- OsteoArthritis; FLEXOFYTOL®; Curcuma; biomarkers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Tilman S.A.Industry (pharma, biotech, devices)
- Collaborators
- Artialis
- Study start
- May 2014
- Primary completion
- Jul 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 21 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
- 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
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Dietary Supplement: FLEXOFYTOL®Group A: FLEXOFYTOL® high dosage |
| Group B | Active comparator | Dietary Supplement: FLEXOFYTOL®Group B: FLEXOFYTOL® low dosage |
| Group C | Placebo comparator | Other: PLACEBOGroup C: PLACEBO |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male or female between the age of 45 and 80
Key exclusion criteria (3 listed)
- Artialis (study coordinator) or Tilman (Sponsor) 's employees
- Participation to a therapeutic clinical trial in the last 3 months
- Under guardianship or judicial protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FLEXOFYTOL®Also: curcuma extractThe product FLEXOFYTOL® is bio-optimized curcumin. | Dietary supplement | Group A, Group B |
| PLACEBO | Other | Group C |
Primary outcome
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)
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)
9 secondary outcomes
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)
Mean knee pain over the last 24 hours using a visual analogue scale (VAS).
Time frame: 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)
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)
Count the capsules in investigation kits brought back by the patient.
Time frame: 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)
Evaluation of Patient's satisfaction by Likert scale.
Time frame: 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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Derived from this study: PubMed 31351488Henrotin 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.
- Decrease of a specific biomarker of collagen degradation in osteoarthritis, Coll2-1, by treatment with highly bioavailable curcumin during an exploratory clinical trialLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FLEXOFYTOL® in people with Osteoarthritis, run by Tilman S.A. at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02909621, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.