Ignite Creation Date:
2024-05-06 @ 6:21 PM
Last Modification Date:
2024-10-26 @ 2:46 PM
Study NCT ID:
NCT05633849
Status:
COMPLETED
Last Update Posted:
2022-12-07
First Post:
2022-10-31
Brief Title:
Evaluation of the Effect of Pro Resolve Sports on Treatment of Patients With Symptomatic Knee Osteoarthritis
Sponsor:
Solutex GC SL
Organization:
Solutex GC SL
Study Overview
Official Title:
Randomized Double-blind Placebo-controlled Study to Evaluate the Effect of Pro Resolve Sports on Treatment of Patients With Symptomatic Knee Osteoarthritis
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GAUDÍ
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
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 LIPINOVASPM 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 andor cognitive disorder Patients were also excluded if they had received chondroitin sulfate glucosamine diacerein corticoids infiltration andor platelet-rich plasma infiltration in the knee three months before the study inclusion NSAIDs three weeks before the inclusion andor 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
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 LIPINOVASPM 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 andor cognitive disorder Patients were also excluded if they had received chondroitin sulfate glucosamine diacerein corticoids infiltration andor platelet-rich plasma infiltration in the knee three months before the study inclusion NSAIDs three weeks before the inclusion andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None