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

NCT ID: NCT05633849

Last Updated: 2022-12-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-30
• Study Completion Date: 2021-10-14

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: PLACEBO_COMPARATOR

Placebo group

Intervention Type: DIETARY_SUPPLEMENT

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

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

Group Type: EXPERIMENTAL

SMP group

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

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

Intervention Type: 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

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 68 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

OAFI Foundation (Osteoarthritis Foundation International)

UNKNOWN

Sponsor Role: collaborator

Solutex GC S.L.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gil Rodas, MD

Role: PRINCIPAL_INVESTIGATOR

Medical Services F.C. Barcelona

Locations

Clínica Segura

Las Rozas de Madrid, Madrid, Spain

Clínica Dr. Rodas

Avilés, Principality of Asturias, Spain

Medical Services Ath, Club Bilbao

Bilbao, Vizcaya, Spain

Instituto Poal de Reumatología

Barcelona, , Spain

Medical Services F.C. Barcelona

Barcelona, , Spain

Countries

Spain

References

Moller I, Rodas G, Villalon JM, Rodas JA, Angulo F, Martinez N, Verges J. Randomized, double-blind, placebo-controlled study to evaluate the effect of treatment with an SPMs-enriched oil on chronic pain and inflammation, functionality, and quality of life in patients with symptomatic knee osteoarthritis: GAUDI study. J Transl Med. 2023 Jun 29;21(1):423. doi: 10.1186/s12967-023-04283-4.

Reference Type: DERIVED

PMID: 37386594 (View on PubMed)

Other Identifiers

GAUDÍ

Identifier Type: -

Identifier Source: org_study_id