Evaluation of 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.

Inclusion Criteria:Adults younger than 68 yearsDiagnosis of symptomatic knee OA (according to the American College of Rheumatology [ACR]), primary knee (OA)Patients with primary knee arthrosisPatients with confirmed 2-3 Kellgren and Lawrence radiologic degreePatients with pain Visual Analogue Scale (VAS) score ≥ 5Patients that signed informed consentExclusion Criteria:Patients allergic to fish or seafoodPatients that had an arthroscopy within the last yearPatients that had been diagnosed with secondary knee osteoarthritisPatients with concomitant illnesses such as cardiopathy, pneumopathy, non-compensated nephropathy, neuropathy affecting mobility, non-compensated psychiatric disorder, fibromyalgia, and/or cognitive disorderPatients that have received NSAIDs during last 3 weeks previous to join the studyPatients that hace received chondroitin sulfate, glucosamine, diacerein, corticoids infiltration, and/or platelet-rich plasma infiltration in the knee three months before the study inclusionPatients that have had a drug abuse record three years before the inclusionPatients that have had a drug abuse record three years before the inclusion