Clinical trial NCT05633849: Evaluation of the Effect of Pro Resolve® Sports on Treatment of Patients With Symptomatic Knee Osteoarthritis
Official title: Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Pro Resolve® Sports on Treatment of Patients With Symptomatic Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: SPMs
Resolvins
Osteoarthritis
Pain
Quality of life
Lead sponsor: Solutex GC S.L.
Sponsor class: INDUSTRY
Collaborators: name: OAFI Foundation (Osteoarthritis Foundation International)
First posted: 2022-12-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, multicentre, double-blind, placebo-controlled, parallel-group pilot study
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Pain
timeFrame: Basal and 12 weeks
Secondary outcomes:
measure: Change in Pain (between groups) assessed by Visual Analogic Scale. Min: 0 (no pain) max: 10 (the worst pain possible)
timeFrame: Basal and 12 weeks
measure: Use of Rescue medication and patient drop-outs
timeFrame: Basal and 12 weeks
measure: Change in functionality assessed by WOMAC (Eastern Ontario McMaster Universities Osteoarthritis Index) score
timeFrame: Basal and 12 weeks
measure: Safety of study product, assessed as percentage of patients suffering adverse events related to study product
timeFrame: 12 weeks
measure: Changes in pain assessed as changes in OMERACT-OARSI score
timeFrame: Basal and 12 weeks
measure: Quality of life of patients assessed as changes in EQ-5D-5L score
timeFrame: Basal and 12 weeks
measure: Inflammatory biomarkers: C-reactive protein (CRP)
timeFrame: Basal and 12 weeks
measure: Inflammatory biomarkers: Interleukin -1 (IL-1)
timeFrame: Basal and 12 weeks
measure: Inflammatory biomarkers: Interleukin-6 (IL-6),
timeFrame: Basal and 12 weeks
measure: Inflammatory biomarkers: Interleukin-8 (IL-8)
timeFrame: Basal and 12 weeks
measure: Inflammatory biomarkers: Tumoral Necrosis Factor -α (TNF-α)
timeFrame: Basal and 12 weeks
Other outcomes:
Locations:
city: Avilés
country: Spain
facility: Clínica Dr. Rodas
state: Asturias
city: Las Rozas
country: Spain
facility: Clínica Segura
state: Madrid
city: Bilbao
country: Spain
facility: Medical Services Ath, Club Bilbao
state: Vizcaya
city: Barcelona
country: Spain
facility: Instituto Poal de Reumatología
city: Barcelona
country: Spain
facility: Medical Services F.C. Barcelona
Study officials:
affiliation: Medical Services F.C. Barcelona
name: Gil Rodas, MD
role: PRINCIPAL_INVESTIGATOR
References: