Knee OsteoarthritisEarly Phase 1NCT01909037
Exploratory Non Comparative Study to Evaluate the Efficacy of Highly Bioavailable Curcumin (Flexofytol) in Patients With Knee Osteoarthritis
A Early Phase 1 study testing Flexofytol (bio-optimized curcumin) in people with Knee Osteoarthritis, run by Tilman S.A. at 1 site in Belgium.
Trial summary
The purpose of this study is to evaluate the efficacy of bio-optimized curcumin(Flexofytol) during a 90-days period in knee ostearthritis patients on the serum levels of specific biomarkers of osteoarthritis and on the evaluation of pain. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Flexofytol (bio-optimized curcumin)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2012to Dec 2012
- Phase
- Early Phase 1
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 45 to 80 years of age
- Internal femorotibial gonarthrosis responding to the clinical and radiological criteria of ACR
- Symptomatic knee for more than 6 months
- Mean knee pain on the last 24 hours of at least 40 mm on VAS
- Kellgren \& Laurence grade II to III
- Patients able to avoid NSAIDs and analgesics during the study
- Patients having signed informed consent
- Patients able to follow the study instructions
Who cannot join
- Related to the osteoarthritis pathology:
- Osteoarthritis linked to a metabolic arthropathy
- Predominant associated symptomatic femoropatellar osteoarthritis
- Chondromatosis or villonodular synovitis of the knee
- Recent trauma (< 1 month) of the knee responsible for the pain
- Inflammatory flare
Show all 27Show fewer
- Pathology potentially interfering with the evaluation (metabolic inflammatory arthropathy, rheumatoid arthritis, lower limb radiculalgia, arthritis...
- Paget disease
- Homolateral coxarthrosis
- Articular Prosthesis
- Knee joint effusion
- Related to previous and associated treatments:
- Corticosteroids injection in the previous month, whatever the joint concerned,
- Hyaluronan injection in the evaluated knee during the previous 6 months,
- NSAID or analgesics in the 72 hours prior to inclusion
- No modification of Slow-acting drugs for OA and/or dietary supplements taken within less than 6 months prior to the study(ex: chondroitin sulfate, diacerein, soy and avocado unsaponifiables, oxaceprol, granions de cuivre, glucosamine, phytotherapy for OA, homeopathy for OA...),
- Anticoagulant (coumarinic) treatment and heparin
- General corticotherapy,
- Contraindication to paracetamol.
- Related to associated pathologies:
- Patient suffering from serious associated illness (liver failure, kidney failure, non-controlled cardiovascular diseases...)
- Related to patients:
- Pregnant or breastfeeding women
- Pre-menopausal women with no contraception
- Patients unable to write
- Patients enrolled in a clinical trial in the previous 3 months
- Patients under juristic protection or under guardianship.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the efficacy of bio-optimized curcumin(Flexofytol) during a 90-days period in knee ostearthritis patients on the serum levels of specific biomarkers of osteoarthritis and on the evaluation of pain.
- Conditions
- Knee Osteoarthritis
- Being tested
- Flexofytol (bio-optimized curcumin)
- Keywords
- osteoarthritis, curcumin, biomarker, pain
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexofytol (bio-optimized curcumin)Dietary supplement
2x3 caps/day (before breakfast and in the evening) for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Flexofytol (bio-optimized curcumin) | Experimental | Not described Receives: Dietary Supplement: Flexofytol (bio-optimized curcumin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum levels of biomarkers of cartilage metabolism and inflammation
Change from baseline of serum levels of biomarkers
Measured: 84 days
Secondary outcomes (1)
Pain and the global patient assessment of disease activity using a Visual Analog Scale (VAS)
Change from baseline of the mean pain over the last 24 hours and of the global assessment of disease activity by the patient
Measured: 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2013 (estimated)
- Study startMar 2012
- Primary completionDec 2012
- Study completionDec 2012
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 Knee 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tilman S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bioxtract SA
- Responsible party
- Sponsor
- Investigators
- Caroline Castermans, MD, Principal investigator, Citadelle Hospital of LiegeYvan Dierckxsens, Study director, Tilman S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01909037
- Sponsor's protocol ID
- TILFLEXFY 002
- Status last verified
- Jul 2013
- First submitted
- 18 Jul 2013
- Last updated
- 23 Jun 2015
- Results posted
- No
Publications
Henrotin Y, Gharbi M, Dierckxsens Y, Priem F, Marty M, Seidel L, Albert A, Heuse E, Bonnet V, Castermans C. Decrease of a specific biomarker of collagen degradation in osteoarthritis, Coll2-1, by treatment with highly bioavailable curcumin during an exploratory clinical trial. BMC Complement Altern Med. 2014 May 17;14:159. doi: 10.1186/1472-6882-14-159.
PubMed 24886572
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Non Comparative Study to Evaluate the Efficacy of Highly Bioavailable Curcumin (Flexofytol) in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT01909037
- Acronym / sponsor ID
- TILFLEXFY 002
- Conditions
- Knee Osteoarthritis
- Keywords
- osteoarthritis, curcumin, biomarker, pain
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Tilman S.A.Industry (pharma, biotech, devices)
- Collaborators
- Bioxtract SA
- Study start
- Mar 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 26 Jul 2013 (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.
The purpose of this study is to evaluate the efficacy of bio-optimized curcumin(Flexofytol) during a 90-days period in knee ostearthritis patients on the serum levels of specific biomarkers of osteoarthritis and on the evaluation of pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Flexofytol (bio-optimized curcumin) | Experimental | Dietary Supplement: Flexofytol (bio-optimized curcumin) |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 45 to 80 years of age
- Internal femorotibial gonarthrosis responding to the clinical and radiological criteria of ACR
- Symptomatic knee for more than 6 months
- Mean knee pain on the last 24 hours of at least 40 mm on VAS
- Kellgren \& Laurence grade II to III
Key exclusion criteria (27 listed)
- Related to the osteoarthritis pathology:
- Related to previous and associated treatments:
- Related to associated pathologies:
- Related to patients:
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 (bio-optimized curcumin)2x3 caps/day (before breakfast and in the evening) for 3 months | Dietary supplement | Flexofytol (bio-optimized curcumin) |
Primary outcome
Serum levels of biomarkers of cartilage metabolism and inflammation
Time frame: 84 days
Change from baseline of serum levels of biomarkers
1 secondary outcome
Pain and the global patient assessment of disease activity using a Visual Analog Scale (VAS)
Time frame: 84 days
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 23 Jun 2015.
- Derived from this study: PubMed 24886572Henrotin Y, Gharbi M, Dierckxsens Y, Priem F, Marty M, Seidel L, Albert A, Heuse E, Bonnet V, Castermans C. Decrease of a specific biomarker of collagen degradation in osteoarthritis, Coll2-1, by treatment with highly bioavailable curcumin during an exploratory clinical trial. BMC Complement Altern Med. 2014 May 17;14:159. doi: 10.1186/1472-6882-14-159.
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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.
Caroline Castermans, MD principal investigator
Citadelle Hospital of Liege
Yvan Dierckxsens study director
Tilman S.A.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Flexofytol (bio-optimized curcumin) in people with Knee 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 8 inclusion and 27 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 23 Jun 2015. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Serum levels of biomarkers of cartilage metabolism and inflammation (time frame: 84 days). 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 NCT01909037, 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 23 Jun 2015.