Resveratrol in Knee Osteoarthritis

Phase 3

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Drug: oral resveratrol; Drug: oral placebo

• Registration Number: NCT02905799
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2016-09-14
• Study First Submitted QC: 2016-09-16
• Study First Posted: 2016-09-19
• Study Start: 2017-11-09
• Primary Completion: 2022-02-09
• Study Completion: 2022-05-12
• Status Verified: 2022-07
• Last Update Submitted: 2024-10-24
• Last Update Posted: 2024-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral resveratrol	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.
Oral Placebo	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

Name	Time	Method
Mean change from baseline in knee pain in the previous 48 hours	at 3 months	Using a self-administered 11-point pain numeric rating scale, with 0 = no pain and 100 = maximal pain

Secondary Outcome Measures

Name	Time	Method
Mean change from baseline in specific activity limitation	at 6 months	Using self-administered WOMAC function subscore, with 0 = no
Mean change from baseline in knee pain in the previous 48 hours	at 6 months	Using a self-administered 11-point pain numeric rating scale, with 0 = no pain and 100 = maximal pain
Proportion of OARSI-OMERACT responders	at 6 months	OARSI-OMERACT response
Number of intra-articular injections of corticosteroids or hyaluronic acid since last contact	at 6 months	using self-reporting
Self-reported consumption of non-steroidal anti-inflammatory drugs since last contact	at 6 months	using a self-administered 4-class scale (never, several times a month, several times a week, daily)
Mean change from baseline in patient's global assessment	at 6 months	Using a self-administered 11-point global assessment numeric rating scale, with 0 = worst possible and 100 = best possible
Self-reported consumption of analgesics (non-opioid, weak and strong opioids) since last contact	at 6 months	using a self-administered 4-class scale (never, several times a month, several times a week, daily)

Trial Locations

Locations (3)

Rehabilitation department , CHU Clermont-Ferrand; 🇫🇷 Cebazat, France

Rheumatology Department, Saint Antoine Hospital; 🇫🇷 Paris, France

Rehabilitation Department, Cochin Hospital; 🇫🇷 Paris, France