Clinical trial NCT02905799: Resveratrol in Knee Osteoarthritis
Official title: Evolution of Pain At Three Months by Oral Resveratrol in Primary Knee Osteoarthritis: a Multicenter, Double-blind, Randomized, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Knee Osteoarthritis
Keywords: Osteoarthritis
Knee
Resveratrol
Oral Treatment
Pain
Trial
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: URC-CIC Paris Descartes Necker Cochin
First posted: 2016-09-19
Enrollment: 142
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

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.

Eligibility 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
* Current use of anticoagulants

Primary outcomes:
measure: Mean change from baseline in knee pain in the previous 48 hours
timeFrame: at 3 months
Secondary outcomes:
measure: Mean change from baseline in knee pain in the previous 48 hours
timeFrame: at 6 months
measure: Mean change from baseline in specific activity limitation
timeFrame: at 3 months
measure: Mean change from baseline in specific activity limitation
timeFrame: at 6 months
measure: Mean change from baseline in patient's global assessment
timeFrame: at 3 months
measure: Mean change from baseline in patient's global assessment
timeFrame: at 6 months
measure: Proportion of OARSI-OMERACT responders
timeFrame: at 3 months
measure: Proportion of OARSI-OMERACT responders
timeFrame: at 6 months
measure: Number of intra-articular injections of corticosteroids or hyaluronic acid since last contact
timeFrame: at 3 months
measure: Number of intra-articular injections of corticosteroids or hyaluronic acid since last contact
timeFrame: at 6 months
measure: Self-reported consumption of analgesics (non-opioid, weak and strong opioids) since last contact
timeFrame: at 3 months
measure: Self-reported consumption of analgesics (non-opioid, weak and strong opioids) since last contact
timeFrame: at 6 months
measure: Self-reported consumption of non-steroidal anti-inflammatory drugs since last contact
timeFrame: at 3 months
measure: Self-reported consumption of non-steroidal anti-inflammatory drugs since last contact
timeFrame: at 6 months
Other outcomes:
Locations:
city: Cebazat
country: France
facility: Rehabilitation department , CHU Clermont-Ferrand
city: Paris
country: France
facility: Rheumatology Department, Saint Antoine Hospital
city: Paris
country: France
facility: Rehabilitation Department, Cochin Hospital
Study officials:
affiliation: Université Paris Descartes, PRES Sorbonne Paris Cité
name: Christelle NGUYEN, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.