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Resveratrol in Knee Osteoarthritis (ARTHROL)

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
oral resveratrol
oral placebo
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Knee Osteoarthritis focused on measuring Osteoarthritis, Knee, Resveratrol, Oral Treatment, Pain, Trial

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rehabilitation department , CHU Clermont-Ferrand
  • Rheumatology Department, Saint Antoine Hospital
  • Rehabilitation Department, Cochin Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Oral resveratrol

Oral Placebo

Arm Description

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 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Mean change from baseline in specific activity limitation
Using self-administered WOMAC function subscore, with 0 = no
Mean change from baseline in specific activity limitation
Using self-administered WOMAC function subscore, with 0 = no
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
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
Proportion of OARSI-OMERACT responders
OARSI-OMERACT response
Proportion of OARSI-OMERACT responders
OARSI-OMERACT response
Number of intra-articular injections of corticosteroids or hyaluronic acid since last contact
using self-reporting
Number of intra-articular injections of corticosteroids or hyaluronic acid since last contact
using self-reporting
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)
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)
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)
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)

Full Information

First Posted
September 14, 2016
Last Updated
July 28, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
URC-CIC Paris Descartes Necker Cochin
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1. Study Identification

Unique Protocol Identification Number
NCT02905799
Brief Title
Resveratrol in Knee Osteoarthritis
Acronym
ARTHROL
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

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
November 9, 2017 (Actual)
Primary Completion Date
February 9, 2022 (Actual)
Study Completion Date
May 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
URC-CIC Paris Descartes Necker Cochin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Osteoarthritis, Knee, Resveratrol, Oral Treatment, Pain, Trial

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
142 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oral resveratrol
Arm Type
Experimental
Arm Description
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.
Arm Title
Oral Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
oral resveratrol
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
oral placebo
Intervention Description
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 Measure Information:
Title
Mean change from baseline in knee pain in the previous 48 hours
Description
Using a self-administered 11-point pain numeric rating scale, with 0 = no pain and 100 = maximal pain
Time Frame
at 3 months
Secondary Outcome Measure Information:
Title
Mean change from baseline in knee pain in the previous 48 hours
Description
Using a self-administered 11-point pain numeric rating scale, with 0 = no pain and 100 = maximal pain
Time Frame
at 6 months
Title
Mean change from baseline in specific activity limitation
Description
Using self-administered WOMAC function subscore, with 0 = no
Time Frame
at 3 months
Title
Mean change from baseline in specific activity limitation
Description
Using self-administered WOMAC function subscore, with 0 = no
Time Frame
at 6 months
Title
Mean change from baseline in patient's global assessment
Description
Using a self-administered 11-point global assessment numeric rating scale, with 0 = worst possible and 100 = best possible
Time Frame
at 3 months
Title
Mean change from baseline in patient's global assessment
Description
Using a self-administered 11-point global assessment numeric rating scale, with 0 = worst possible and 100 = best possible
Time Frame
at 6 months
Title
Proportion of OARSI-OMERACT responders
Description
OARSI-OMERACT response
Time Frame
at 3 months
Title
Proportion of OARSI-OMERACT responders
Description
OARSI-OMERACT response
Time Frame
at 6 months
Title
Number of intra-articular injections of corticosteroids or hyaluronic acid since last contact
Description
using self-reporting
Time Frame
at 3 months
Title
Number of intra-articular injections of corticosteroids or hyaluronic acid since last contact
Description
using self-reporting
Time Frame
at 6 months
Title
Self-reported consumption of analgesics (non-opioid, weak and strong opioids) since last contact
Description
using a self-administered 4-class scale (never, several times a month, several times a week, daily)
Time Frame
at 3 months
Title
Self-reported consumption of analgesics (non-opioid, weak and strong opioids) since last contact
Description
using a self-administered 4-class scale (never, several times a month, several times a week, daily)
Time Frame
at 6 months
Title
Self-reported consumption of non-steroidal anti-inflammatory drugs since last contact
Description
using a self-administered 4-class scale (never, several times a month, several times a week, daily)
Time Frame
at 3 months
Title
Self-reported consumption of non-steroidal anti-inflammatory drugs since last contact
Description
using a self-administered 4-class scale (never, several times a month, several times a week, daily)
Time Frame
at 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christelle NGUYEN, MD, PhD
Organizational Affiliation
Université Paris Descartes, PRES Sorbonne Paris Cité
Official's Role
Study Director
Facility Information:
Facility Name
Rehabilitation department , CHU Clermont-Ferrand
City
Cebazat
ZIP/Postal Code
63118
Country
France
Facility Name
Rheumatology Department, Saint Antoine Hospital
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Rehabilitation Department, Cochin Hospital
City
Paris
ZIP/Postal Code
75014
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28965100
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.
Results Reference
result

Learn more about this trial

Resveratrol in Knee Osteoarthritis

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