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Knee OsteoarthritisPhase 3ARTHROLNCT02905799

Resveratrol in Knee Osteoarthritis

A Phase 3 study testing oral resveratrol in people with Knee Osteoarthritis, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine whether resveratrol is effective in the treatment of painful knee osteoarthritis. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Knee Osteoarthritis
What is being tested?
oral resveratrol
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
142 participants
Where
3 sitesFrance
Study dates
9 Nov 2017to 12 May 2022
Phase
Phase 3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 40 years-old
  • Knee osteoarthritis fulfilling 1986 American College of Rheumatology (ACR) criteria
  • Pain on numeric rating scale ≥ 40/100
  • Symptom duration ≥ 1 month
  • Kellgren and Lawrence X-Ray score 1, 2 or 3
  • Written consent obtained
  • Health insurance cover

Who cannot join

  • History of symptomatic crystal or inflammatory arthritis
  • Knee surgery ≤ 1 year
  • Knee trauma ≤ 2 months
  • Knee intra-articular injections of corticosteroids and/or hyaluronic acid ≤ 2 months
  • Neurologic disorders involving the lower limbs
  • Patient not understanding and not speaking french
Show all 11Show fewer
  • Participation in another biomedical research
  • Contraindication to resveratrol or hypersensitivity to any of its constituents
  • Current use of intramuscular, intravenous or oral corticosteroids
  • Uncontrolled diseases that may require intramuscular, intravenous or oral corticosteroids
  • Current use of anticoagulants

Trial locations and contacts

3 sites in 1 country.

France3 sites

  • Rehabilitation department , CHU Clermont-Ferrand

    Cébazat, 63118

  • Rheumatology Department, Saint Antoine Hospital

    Paris, Paris, 75012

  • Rehabilitation Department, Cochin Hospital

    Paris, Paris, 75014

Other trials in France

About this study

Official title: Evolution of Pain at Three Months by Oral Resveratrol in Primary Knee Osteoarthritis: a Multicenter, Double-blind, Randomized, Placebo-controlled Trial

The purpose of this study is to determine whether resveratrol is effective in the treatment of painful knee osteoarthritis.

Read the detailed description

Osteoarthritis (OA) is the first cause of handicap in individuals over 40 years-old in France. OA physiopathology is driven in part by local joint inflammation responsible for pain and joint destruction. Experimental studies have shown that resveratrol, a molecule antagonist to the aryl hydrocarbon receptor, has anti-inflammatory and chondroprotective properties in vitro and in vivo. The investigators hypothesize that oral resveratrol, in a new formulation improving its bioavailability, could reduce knee pain at 3 months as compared with placebo in people with knee OA.

Being tested
oral resveratrol, oral placebo
Keywords
Osteoarthritis, Knee, Resveratrol, Oral Treatment, Pain, Trial
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.

  • oral resveratrolDrug

    Resveratrol will be administered orally, at the dose of 40 mg (2 caplets) twice a day for one week, then at the dose of 20 mg (1 caplet) twice a day, for a total duration of 6 months.

  • oral placeboDrug

    Placebo will be administered orally : 2 caplets twice a day for one week, then 1 caplet twice a day, for a total duration of 6 months

Study groups in NCT02905799
Study groupRoleWhat they receive
Oral resveratrolExperimentalResveratrol will be administered orally, at the dose of 40 mg (2 caplets) twice a day for one week, then at the dose of 20 mg (1 caplet) twice a day, for a total duration of 6 months.
Receives: Drug: oral resveratrol
Oral PlaceboPlacebo comparatorPlacebo will be administered orally : 2 caplets twice a day for one week, then 1 caplet twice a day, for a total duration of 6 months.
Receives: Drug: oral placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean change from baseline in knee pain in the previous 48 hours

    Using a self-administered 11-point pain numeric rating scale, with 0 = no pain and 100 = maximal pain

    Measured: at 3 months

Secondary outcomes (13)

  1. Mean change from baseline in knee pain in the previous 48 hours

    Using a self-administered 11-point pain numeric rating scale, with 0 = no pain and 100 = maximal pain

    Measured: at 6 months

  2. Mean change from baseline in specific activity limitation

    Using self-administered WOMAC function subscore, with 0 = no

    Measured: at 3 months

  3. Mean change from baseline in specific activity limitation

    Using self-administered WOMAC function subscore, with 0 = no

    Measured: at 6 months

  4. Mean change from baseline in patient's global assessment

    Using a self-administered 11-point global assessment numeric rating scale, with 0 = worst possible and 100 = best possible

    Measured: at 3 months

  5. Mean change from baseline in patient's global assessment

    Using a self-administered 11-point global assessment numeric rating scale, with 0 = worst possible and 100 = best possible

    Measured: at 6 months

  6. Proportion of OARSI-OMERACT responders

    OARSI-OMERACT response

    Measured: at 3 months

  7. Proportion of OARSI-OMERACT responders

    OARSI-OMERACT response

    Measured: at 6 months

  8. Number of intra-articular injections of corticosteroids or hyaluronic acid since last contact

    using self-reporting

    Measured: at 3 months

  9. Number of intra-articular injections of corticosteroids or hyaluronic acid since last contact

    using self-reporting

    Measured: at 6 months

  10. Self-reported consumption of analgesics (non-opioid, weak and strong opioids) since last contact

    using a self-administered 4-class scale (never, several times a month, several times a week, daily)

    Measured: at 3 months

  11. Self-reported consumption of analgesics (non-opioid, weak and strong opioids) since last contact

    using a self-administered 4-class scale (never, several times a month, several times a week, daily)

    Measured: at 6 months

  12. Self-reported consumption of non-steroidal anti-inflammatory drugs since last contact

    using a self-administered 4-class scale (never, several times a month, several times a week, daily)

    Measured: at 3 months

  13. Self-reported consumption of non-steroidal anti-inflammatory drugs since last contact

    using a self-administered 4-class scale (never, several times a month, several times a week, daily)

    Measured: at 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2016 (estimated)
  2. Study start9 Nov 2017
  3. Primary completion9 Feb 2022
  4. Study completion12 May 2022

Resources

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 3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
142 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02905799
Sponsor's protocol ID
P150938
Other IDs
2016-A01310-51
Acronym
ARTHROL
Status last verified
Mar 2026
First submitted
14 Sep 2016
Last updated
4 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Nguyen C, Coudeyre E, Boutron I, Baron G, Daste C, Lefevre-Colau MM, Sellam J, Zauderer J, Berenbaum F, Rannou F. Oral resveratrol in adults with knee osteoarthritis: A randomized placebo-controlled trial (ARTHROL). PLoS Med. 2024 Aug 13;21(8):e1004440. doi: 10.1371/journal.pmed.1004440. eCollection 2024 Aug.

    PubMed 39137167

  • Nguyen C, Boutron I, Baron G, Coudeyre E, Berenbaum F, Poiraudeau S, Rannou F. Evolution of pain at 3 months by oral resveratrol in knee osteoarthritis (ARTHROL): protocol for a multicentre randomised double-blind placebo-controlled trial. BMJ Open. 2017 Sep 29;7(9):e017652. doi: 10.1136/bmjopen-2017-017652.

    PubMed 28965100

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing oral resveratrol in people with Knee Osteoarthritis, run by Assistance Publique - Hôpitaux de Paris at 3 sites 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 7 inclusion and 11 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 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Mean change from baseline in knee pain in the previous 48 hours (time frame: at 3 months). 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 NCT02905799, which also lists 2 linked publications.

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 4 Mar 2026.

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