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

NCT05633849 | Completed

• 1 other identifier: GAUDÍ
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 5

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.

Conditions

Knee Osteoarthritis

Keywords

SPMs; Resolvins; Osteoarthritis; Pain; Quality of life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Change in Pain (between groups) assessed by Visual Analogic Scale. Min: 0 (no pain) max: 10 (the worst pain possible)

  Basal and 12 weeks

• Use of Rescue medication and patient drop-outs

  Basal and 12 weeks

• Change in functionality assessed by WOMAC (Eastern Ontario McMaster Universities Osteoarthritis Index) score

  Basal and 12 weeks

• Safety of study product, assessed as percentage of patients suffering adverse events related to study product

  12 weeks

• Changes in pain assessed as changes in OMERACT-OARSI score

  Basal and 12 weeks

Study Arms (2)

Placebo group

PLACEBO COMPARATOR

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

Specialized pro-resolving mediators (SMP) group

EXPERIMENTAL

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

Interventions

SMP group 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

Specialized pro-resolving mediators (SMP) group

Placebo group 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

Placebo group

Eligibility Criteria

• Age: 18 Years - 68 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Solutex GC S.L.: lead
• OAFI Foundation (Osteoarthritis Foundation International): collaborator

Study Sites (5)

Clínica Segura

Las Rozas de Madrid, Madrid, Spain

Location

Clínica Dr. Rodas

Avilés, Principality of Asturias, Spain

Location

Medical Services Ath, Club Bilbao

Bilbao, Vizcaya, Spain

Location

Instituto Poal de Reumatología

Barcelona, Spain

Location

Medical Services F.C. Barcelona

Barcelona, Spain

Location

Related Publications (1)

• 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.

  PMID: 37386594 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis; Pain

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gil Rodas, MD

  Medical Services F.C. Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: randomized, multicentre, double-blind, placebo-controlled, parallel-group pilot study

Study Record Dates

• First Submitted: October 31, 2022
• First Posted: December 1, 2022
• Study Start: May 30, 2018
• Primary Completion: October 14, 2021
• Study Completion: October 14, 2021
• Last Updated: December 7, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (5)