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Resveratrol in Knee Osteoarthritis (ARTHROL)

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ClinicalTrials.gov Identifier: NCT02905799
Recruitment Status : Recruiting
First Posted : September 19, 2016
Last Update Posted : December 8, 2017
Sponsor:
Collaborator:
Unité de Recherche Clinique (URC) Paris Descartes Cochin
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Drug: oral resveratrol Drug: oral placebo Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 164 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: Evolution of Pain at Three Months by Oral Resveratrol in Primary Knee Osteoarthritis: a Multicenter, Double-blind, Randomized, Placebo-controlled Trial
Actual Study Start Date : November 9, 2017
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
Drug Information available for: Resveratrol

Arm Intervention/treatment
Experimental: Oral resveratrol
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.
Drug: oral resveratrol
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.

Placebo Comparator: Oral Placebo
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.
Drug: oral placebo
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




Primary Outcome Measures :
  1. Mean change from baseline in knee pain in the previous 48 hours [ Time Frame: at 3 months ]
    Using a self-administered 11-point pain numeric rating scale, with 0 = no pain and 100 = maximal pain


Secondary Outcome Measures :
  1. Mean change from baseline in knee pain in the previous 48 hours [ Time Frame: at 6 months ]
    Using a self-administered 11-point pain numeric rating scale, with 0 = no pain and 100 = maximal pain

  2. Mean change from baseline in specific activity limitation [ Time Frame: at 3 months ]
    Using self-administered WOMAC function subscore, with 0 = no

  3. Mean change from baseline in specific activity limitation [ Time Frame: at 6 months ]
    Using self-administered WOMAC function subscore, with 0 = no

  4. Mean change from baseline in patient's global assessment [ Time Frame: at 3 months ]
    Using a self-administered 11-point global assessment numeric rating scale, with 0 = worst possible and 100 = best possible

  5. Mean change from baseline in patient's global assessment [ Time Frame: at 6 months ]
    Using a self-administered 11-point global assessment numeric rating scale, with 0 = worst possible and 100 = best possible

  6. Proportion of OARSI-OMERACT responders [ Time Frame: at 3 months ]
    OARSI-OMERACT response

  7. Proportion of OARSI-OMERACT responders [ Time Frame: at 6 months ]
    OARSI-OMERACT response

  8. Number of intra-articular injections of corticosteroids or hyaluronic acid since last contact [ Time Frame: at 3 months ]
    using self-reporting

  9. Number of intra-articular injections of corticosteroids or hyaluronic acid since last contact [ Time Frame: at 6 months ]
    using self-reporting

  10. Self-reported consumption of analgesics (non-opioid, weak and strong opioids) since last contact [ Time Frame: at 3 months ]
    using a self-administered 4-class scale (never, several times a month, several times a week, daily)

  11. Self-reported consumption of analgesics (non-opioid, weak and strong opioids) since last contact [ Time Frame: at 6 months ]
    using a self-administered 4-class scale (never, several times a month, several times a week, daily)

  12. Self-reported consumption of non-steroidal anti-inflammatory drugs since last contact [ Time Frame: at 3 months ]
    using a self-administered 4-class scale (never, several times a month, several times a week, daily)

  13. Self-reported consumption of non-steroidal anti-inflammatory drugs since last contact [ Time Frame: at 6 months ]
    using a self-administered 4-class scale (never, several times a month, several times a week, daily)



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02905799


Contacts
Contact: François Rannou, MD, PhD +33 1 58 41 25 35 francois.rannou@aphp.fr
Contact: Alexandra BRUNEAU, Master + 33 1 58 41 12 13 alexandra.bruneau@aphp.fr

Locations
France
Rehabilitation department , CHU Clermont-Ferrand Not yet recruiting
Cebazat, France, 63118
Contact: Emmanuel Coudeyre, MD, PhD    +33473750900    ecoudeyre@chu-clermontferrand.fr   
Rheumatology Department, Saint Antoine Hospital Not yet recruiting
Paris, France, 75012
Contact: Francis Berenbaum, MD, PhD    +33149282520    francis.berenbaum@aphp.fr   
Rehabilitation Department, Cochin Hospital Recruiting
Paris, France, 75014
Contact: François Rannou, MD, PhD    +33 1 58 41 25 35    francois.rannou@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Unité de Recherche Clinique (URC) Paris Descartes Cochin
Investigators
Study Director: Christelle NGUYEN, MD, PhD Université Paris Descartes, PRES Sorbonne Paris Cité

Publications of Results:
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02905799     History of Changes
Other Study ID Numbers: P150938
2016-A01310-51 ( Registry Identifier: ANSM )
First Posted: September 19, 2016    Key Record Dates
Last Update Posted: December 8, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Osteoarthritis
Knee
Resveratrol
Oral Treatment
Pain
Trial

Additional relevant MeSH terms:
Resveratrol
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Antimutagenic Agents
Anticarcinogenic Agents