Evaluation of the Effect of Pro Resolve® Sports on Treatment of Patients With Symptomatic Knee Osteoarthritis (GAUDÍ)

Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Pro Resolve® Sports on Treatment of Patients With Symptomatic Knee Osteoarthritis

The GAUDI study was a randomized, multicentre, double-blind, placebo-controlled, parallel-group pilot study conducted in 5 Spanish sites.

Eligible patients were adults younger than 68 years diagnosed with symptomatic knee Osteoarthritis and pain score (VAS) ≥ 5.

The primary endpoint was the change in pain from baseline to week 12. Secondary endpoints included the comparison in the change of pain, stiffness, and function according to the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) between groups from baseline to week 12, the assessment of the constant, intermittent, and total pain according to OMERACT-OARSI score, the changes in health-related quality of life score measured by the EUROQoL-5 questionnaire (16) between both study groups, the use of rescue, and anti-inflammatory medication, and the incidence of adverse events (AEs) during the study.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Dietary supplement: Placebo group; Dietary supplement: SMP group

Detailed Description

The GAUDI study was a randomized, multicentre, double-blind, placebo-controlled, parallel-group pilot study conducted in 5 Spanish centers in compliance with the World Medical Association Declaration of Helsinki, all its amendments, and national regulations. The Independent Ethic Committee of Hospital U. La Paz (Madrid, Spain) approved this study. All patients gave their written informed consent.

The study duration was 24 weeks, including a screening period, a treatment period with monthly visits from the start of the study until week 12, and a follow-up visit 24 weeks after the study initiation conducted by telephone call.

Participants were instructed to take two 500 mg softgels of LIPINOVA(SPM group) or olive oil placebo (placebo group) after breakfast and two after dinner during the first 6 weeks of the study. During the next 6 weeks, participants were instructed to take one softgel after breakfast and one after dinner. Thus, the treatment period was 12 weeks.

Eligible patients were adults younger than 68 years diagnosed with symptomatic knee OA (according to the American College of Rheumatology [ACR]), primary knee (OA), confirmed 2-3 Kellgren and Lawrence radiologic degree (15), and pain Visual Analogue Scale (VAS) score ≥ 5. Patients were excluded if they were allergic to fish or seafood, had an arthroscopy within the last year, had been diagnosed with secondary knee osteoarthritis, cardiopathy, pneumopathy, non-compensated nephropathy, neuropathy affecting mobility, non-compensated psychiatric disorder, fibromyalgia, and/or cognitive disorder. Patients were also excluded if they had received chondroitin sulfate, glucosamine, diacerein, corticoids infiltration, and/or platelet-rich plasma infiltration in the knee three months before the study inclusion, NSAIDs three weeks before the inclusion, and/or hyaluronic acid infiltration in the knee six months before the inclusion. Patients could not have had a drug abuse record three years before the inclusion and have participated in another clinical trial.

The primary endpoint was the change in pain measured on a VAS from baseline to week 12. Secondary endpoints included the comparison in the change of pain, stiffness, and function according to the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) between groups from baseline to week 12, the assessment of the constant, intermittent, and total pain according to OMERACT-OARSI score, the changes in health-related quality of life score measured by the EUROQoL-5 questionnaire (16) between both study groups, the use of concomitant, rescue, and anti-inflammatory medication, and the incidence of adverse events (AEs) during the study.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain
    • Instituto Poal de Reumatología
  • Barcelona, Spain
    • Medical Services F.C. Barcelona
  • Asturias
    • Avilés, Asturias, Spain
      • Clínica Dr. Rodas
  • Madrid
    • Las Rozas, Madrid, Spain
      • Clínica Segura
  • Vizcaya
    • Bilbao, Vizcaya, Spain
      • Medical Services Ath, Club Bilbao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults younger than 68 years
• Diagnosis of symptomatic knee OA (according to the American College of Rheumatology [ACR]), primary knee (OA)
• Patients with primary knee arthrosis
• Patients with confirmed 2-3 Kellgren and Lawrence radiologic degree
• Patients with pain Visual Analogue Scale (VAS) score ≥ 5
• Patients that signed informed consent

Exclusion Criteria:

• Patients allergic to fish or seafood
• Patients that had an arthroscopy within the last year
• Patients that had been diagnosed with secondary knee osteoarthritis
• Patients with concomitant illnesses such as cardiopathy, pneumopathy, non-compensated nephropathy, neuropathy affecting mobility, non-compensated psychiatric disorder, fibromyalgia, and/or cognitive disorder
• Patients that have received NSAIDs during last 3 weeks previous to join the study
• Patients that hace received chondroitin sulfate, glucosamine, diacerein, corticoids infiltration, and/or platelet-rich plasma infiltration in the knee three months before the study inclusion
• Patients that have had a drug abuse record three years before the inclusion
• Patients that have had a drug abuse record three years before the inclusion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo group; In placebo group, participants were instructed to take two 500 mg olive oil placebo (placebo group) after breakfast and two after dinner during the first 6 weeks of the study. During the next 6 weeks, participants were instructed to take one softgel after breakfast and one after dinner. Thus, the treatment period was 12 weeks	Dietary supplement: Placebo group; Participants were instructed to take two 500 mg softgels of olive oil placebo after breakfast and two after dinner during the first 6 weeks of the study. During the next 6 weeks, participants were instructed to take one softgel after breakfast and one after dinner. Thus, the treatment period was 12 weeks
Experimental: Specialized pro-resolving mediators (SMP) group; In SPM group, Participants were instructed to take two 500 mg softgels of LIPINOVA after breakfast and two after dinner during the first 6 weeks of the study. During the next 6 weeks, participants were instructed to take one softgel after breakfast and one after dinner. Thus, the treatment period was 12 weeks	Dietary supplement: SMP group; Participants were instructed to take two 500 mg softgels of LIPINOVA(SPM group) after breakfast and two after dinner during the first 6 weeks of the study. During the next 6 weeks, participants were instructed to take one softgel after breakfast and one after dinner. Thus, the treatment period was 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain	Change in pain measured on a visual analogic scale (VAS) (intragroup). Min: 0 (no pain) max: 10 (the worst pain possible)	Basal and 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain (between groups) assessed by Visual Analogic Scale. Min: 0 (no pain) max: 10 (the worst pain possible)	Change in pain (between groups)	Basal and 12 weeks
Use of Rescue medication and patient drop-outs	Percentage of patients that drops-out the study and percentage of patients that need to use rescue medication during the study	Basal and 12 weeks
Change in functionality assessed by WOMAC (Eastern Ontario McMaster Universities Osteoarthritis Index) score	Changes in functionality using WOMAC score. Min: 0 (better), max: 96 (worse)	Basal and 12 weeks
Safety of study product, assessed as percentage of patients suffering adverse events related to study product	% of adverse events related to study product	12 weeks
Changes in pain assessed as changes in OMERACT-OARSI score	Changes in OMERACT-OARSI score. Min: 0 (better), max 44 (worse)	Basal and 12 weeks
Quality of life of patients assessed as changes in EQ-5D-5L score	Changes in Quality of life (EQ-5D). Visual analogue scale (quantitative): min: 0 (worse), max: 100 (better). qualitative variables: mobility, self-care, usual activities, pain/discomfort, anxiety/depression Min: 1 (better); max: 5 (worse)	Basal and 12 weeks
Inflammatory biomarkers: C-reactive protein (CRP)	Changes in Inflammatory biomarkers: CRP	Basal and 12 weeks
Inflammatory biomarkers: Interleukin -1 (IL-1)	Changes in Inflammatory biomarkers: IL-1	Basal and 12 weeks
Inflammatory biomarkers: Interleukin-6 (IL-6),	Changes in Inflammatory biomarkers: IL-6	Basal and 12 weeks
Inflammatory biomarkers: Interleukin-8 (IL-8)	Changes in Inflammatory biomarkers: IL-8	Basal and 12 weeks
Inflammatory biomarkers: Tumoral Necrosis Factor -α (TNF-α)	Changes in Inflammatory biomarkers: TNF-α	Basal and 12 weeks

Collaborators and Investigators

• Sponsor: Solutex GC S.L.
• Collaborators: OAFI Foundation (Osteoarthritis Foundation International)
• Investigators: Principal Investigator: Gil Rodas, MD, Medical Services F.C. Barcelona

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2018
• Primary Completion (Actual): October 14, 2021
• Study Completion (Actual): October 14, 2021

Study Registration Dates

• First Submitted: October 31, 2022
• First Submitted That Met QC Criteria: November 21, 2022
• First Posted (Actual): December 1, 2022

Study Record Updates

• Last Update Posted (Estimate): December 7, 2022
• Last Update Submitted That Met QC Criteria: December 5, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Osteoarthritis; Pain; Quality of life; Resolvins; SPMs
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: GAUDÍ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No