Osteoarthritis, KneePhase 2NCT00992004
Evaluation of the Efficacy of a Turmeric Extract (Arantal®) in Patients With Osteoarthritis of the Knee (Gonarthrosis).
A Phase 2 study testing Arantal® (highly bioavailable turmeric extract) in people with Osteoarthritis, Knee, run by Bioxtract SA at 1 site in France.
Trial summary
The purpose of this study is to determine the efficacy and the tolerance on 15 days of a turmeric extract (Arantal®) on pain related to gonarthrosis. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Arantal® (highly bioavailable turmeric extract)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2009to May 2010
- Phase
- Phase 2
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is 40 through 80 years of age
- Subject diagnosed with femorotibial osteoarthritis of the knee (diagnosed according to the clinical and radiologic criteria of ACR),
- Patient's Assessment of Arthritis Pain measurement on the last 24 hours of at least 50 mm on VAS,
- Patient has not received any NSAIDs within 72 hours and any analgesics within 24 hours,
- Patients with chronic knee pain (i.e., knee pain at least every other day during the month preceding inclusion),
- Patients with radiologic knee osteoarthritis (Kellgren-Lawrence grade 2-4, on radiography less than 12 months old),
- Patients having signed the informed consent,
- Patients capable of comprehend the study instructions.
Who cannot join
- Related to the osteoarthritis pathology:
- Osteoarthritis linked to a metabolic arthropathy: chondrocalcinosis already diagnosed or defined by calcium edging on at least one femorotibial joint space, gout...,
- Predominant associated symptomatic femoropatellar osteoarthritis,
- Chondromatosis or villonodular synovitis of the knee,
- Recent trauma (< 1 month) of the knee responsible for the pain,
- Knee joint effusion justifying an evacuation through puncturing,
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- Inflammatory flare (night pain, joint effusion) corresponding to a KOFUS score less than 7,
- Pathology potentially interfering with the evaluation (metabolic inflammatory arthropathy, rheumatoid arthritis, lower limb radiculalgia, arthritis...),
- 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,
- Patient who took NSAID in the 72 hours prior to inclusion or Analgesics in the 24 hours prior to inclusion,
- Slow-acting drugs for OA and/or dietary supplements taken within less than 3 months prior to the study product administration or for which the dose has been modified in the last three months (ex: chondroitin sulfate, diacerein, soy and avocado unsaponifiables, oxaceprol, granions de cuivre, glucosamine, phytotherapy for OA, homeopathy for OA...),
- Anticoagulant treatment without gastric protection,
- General corticotherapy,
- Contraindication to paracetamol.
- Related to associated pathologies:
- Patient suffering from serious associated illness (liver failure, kidney failure, non-controlled cardiovascular diseases...),
- Peptic ulcer.
- 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
Official title: Comparative, Randomized, Double-blind, Placebo-controlled, Parallel Group Study, to Evaluate the Efficacy of a Turmeric Extract (Arantal®) Versus Placebo in Patients With Osteoarthritis of the Knee (Gonarthrosis).
The purpose of this study is to determine the efficacy and the tolerance on 15 days of a turmeric extract (Arantal®) on pain related to gonarthrosis.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Arantal® (highly bioavailable turmeric extract)
- Keywords
- Osteoarthritis, Knee, Osteoarthritis, Joint Diseases, Arthritis, Rheumatic Diseases
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Joint Diseases, Arthritis, Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arantal® (highly bioavailable turmeric extract)Dietary supplement
4 capsules a day, before breakfast
| Study group | Role | What they receive |
|---|---|---|
| Arantal® | Experimental | Highly bioavailable turmeric extract (food supplement) Receives: Dietary Supplement: Arantal® (highly bioavailable turmeric extract) |
| Placebo | Placebo comparator | Same capsule without the active ingredients (only excipients) Receives: Dietary Supplement: Arantal® (highly bioavailable turmeric extract) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS)
Measured: 15 days
Secondary outcomes (1)
Kinetics of the analgesic effect by a variance analysis in repeated measures (Likert Scale)
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2009 (estimated)
- Study startJun 2009
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bioxtract SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nukleus
- Investigators
- Yves Henrotin, Pr, Principal investigator, University of Liege - Bone and Cartilage Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00992004
- Sponsor's protocol ID
- ARKOS
- Other IDs
- 2009-A00174-53
- Status last verified
- May 2010
- First submitted
- 7 Oct 2009
- Last updated
- 7 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative, Randomized, Double-blind, Placebo-controlled, Parallel Group Study, to Evaluate the Efficacy of a Turmeric Extract (Arantal®) Versus Placebo in Patients With Osteoarthritis of the Knee (Gonarthrosis).
- ClinicalTrials.gov ID
- NCT00992004
- Acronym / sponsor ID
- ARKOS
- Conditions
- Osteoarthritis, Knee
- Keywords
- Osteoarthritis, Knee, Osteoarthritis, Joint Diseases, Arthritis, Rheumatic Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Bioxtract SAIndustry (pharma, biotech, devices)
- Collaborators
- Nukleus
- Study start
- Jun 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 8 Oct 2009 (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 determine the efficacy and the tolerance on 15 days of a turmeric extract (Arantal®) on pain related to gonarthrosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arantal® | Experimental | Dietary Supplement: Arantal® (highly bioavailable turmeric extract)Highly bioavailable turmeric extract (food supplement) |
| Placebo | Placebo comparator | Dietary Supplement: Arantal® (highly bioavailable turmeric extract)Same capsule without the active ingredients (only excipients) |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient is 40 through 80 years of age
- Subject diagnosed with femorotibial osteoarthritis of the knee (diagnosed according to the clinical and radiologic criteria of ACR),
- Patient's Assessment of Arthritis Pain measurement on the last 24 hours of at least 50 mm on VAS,
- Patient has not received any NSAIDs within 72 hours and any analgesics within 24 hours,
- Patients with chronic knee pain (i.e., knee pain at least every other day during the month preceding inclusion),
Key exclusion criteria (25 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 |
|---|---|---|
| Arantal® (highly bioavailable turmeric extract)4 capsules a day, before breakfast | Dietary supplement | Arantal®, Placebo |
Primary outcome
Patient's Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS)
Time frame: 15 days
1 secondary outcome
Kinetics of the analgesic effect by a variance analysis in repeated measures (Likert Scale)
Time frame: 15 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 7 May 2010.
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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.
Yves Henrotin, Pr principal investigator
University of Liege - Bone and Cartilage Research Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Arantal® (highly bioavailable turmeric extract) in people with Osteoarthritis, Knee, run by Bioxtract SA at 1 site in France.
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 25 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 7 May 2010. 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 France. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Patient's Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS) (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 May 2010.