Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05633849 |
| Other study ID # |
GAUDÍ |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 30, 2018 |
| Est. completion date |
October 14, 2021 |
Study information
| Verified date |
December 2022 |
| Source |
Solutex GC S.L. |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
