Resveratrol in Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

— ARTHROL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02905799
• Other study ID #: P150938
• Secondary ID: 2016-A01310-51
• Status: Completed
• Phase: Phase 3
• Start date: November 9, 2017
• Est. completion date: May 12, 2022

Study information

• Verified date: July 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: May 12, 2022
• Est. primary completion date: February 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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 in?ammatory 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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.
• 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

Locations

Country	Name	City	State
France	Rehabilitation department , CHU Clermont-Ferrand	Cebazat
France	Rehabilitation Department, Cochin Hospital	Paris
France	Rheumatology Department, Saint Antoine Hospital	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	URC-CIC Paris Descartes Necker Cochin

Country where clinical trial is conducted

France, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	at 3 months
Secondary	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	at 6 months
Secondary	Mean change from baseline in specific activity limitation	Using self-administered WOMAC function subscore, with 0 = no	at 3 months
Secondary	Mean change from baseline in specific activity limitation	Using self-administered WOMAC function subscore, with 0 = no	at 6 months
Secondary	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	at 3 months
Secondary	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	at 6 months
Secondary	Proportion of OARSI-OMERACT responders	OARSI-OMERACT response	at 3 months
Secondary	Proportion of OARSI-OMERACT responders	OARSI-OMERACT response	at 6 months
Secondary	Number of intra-articular injections of corticosteroids or hyaluronic acid since last contact	using self-reporting	at 3 months
Secondary	Number of intra-articular injections of corticosteroids or hyaluronic acid since last contact	using self-reporting	at 6 months
Secondary	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)	at 3 months
Secondary	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)	at 6 months
Secondary	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)	at 3 months
Secondary	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)	at 6 months