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ISRCTN
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ISRCTN76960238
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ClinicalTrials.gov identifier
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Public title
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Assessing the clinical benefit of food supplement, Genecol®, in subjects with joint pain at the lower, upper limbs or at the lumbar spine
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Scientific title
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A randomised, double-blind, placebo controlled phase IV trial to assess the clinical benefit of Genacol®, a food supplement made of a proprietary collagen hydrolysate (1200 mg/day), over a period of 24 weeks, in subjects with joint pain at the lower, upper limbs or at the lumbar spine
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Acronym
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NA
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Serial number at source
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NUTRA-CH-01
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Study hypothesis
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Genacol® is a food supplement made of a proprietary collagen hydrolysate already registered, as food supplement, in various countries, including Belgium, Canada, France, the United Kingdom, Spain, Italy, the United States, and others. The aim of this supplementation is to reduce pain and reduce functional disabilities in subject with joint pain.
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Lay summary
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Ethics approval
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The Ethics Committee of Liege CHU approved on the 17th of June 2009 (ref: B70720096310)
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Study design
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Randomised double blind placebo controlled study
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Countries of recruitment
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Belgium
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Disease/condition/study domain
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Joint pain
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Participants - inclusion criteria
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Men and women over 50 years with joint pain (hip, knee, elbow, shoulder, hand and lumbar spine) over 30mm on a 0-100mm visual analogue scale.
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Participants - exclusion criteria
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1. Unlikely to cooperate in the study
2. Poor compliance anticipated by the investigator
3. Participating in another trial at the same time or within the previous 1 months with active therapeutic intervention (except if the patient only performed the screening visit without taking the tested supplement)
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Anticipated start date
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01/07/2009
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Anticipated end date
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01/07/2010
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use contact details below to request a patient information sheet.
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Target number of participants
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200
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Interventions
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Participants will be randomised to receive
1. Genacol®
Active ingredient: Collagene hydrolysate (400 mg/capsule; 1200 mg/day)
2. Placebo
Main ingredient: maltodextrin (400mg/capsule; 1200mg/day)
Participants will be required to take 3 hard gel capsules once daily before bed during the entire study period (24 weeks)
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Primary outcome measure(s)
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Percentage of clinical responders between the active treatment and placebo groups
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Secondary outcome measure(s)
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Outcomes will be evaluated at weeks 12 and 24
1. Pain rescue treatment consumption
2. Pain/function changes; assessed by
2.1. Visual analogue scale (VAS)
2.2. Lequesne index
2.3. Disability of Arm Shoulder and Hand (DASH) score
2.4. Functional Disability Scale for the Assessment of Low Back Pain (Echelle d'Incapacité Fonctionnelle pour l'Evaluation des Lombalgies [EIFEL]) questionnaire
3. Health-related quality of life changes; assessed with the SF-36
4. Utility value changes; assessed by EQ-5D
5. Tolerability and incidence of any adverse events
6. Global satisfaction of the treatment will be assessed by mean of a global questionnaire (also at week 4)
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Sources of funding
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Nutraveris (France)
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Trial website
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Publications
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Contact name
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Prof
Jean-Yves
Reginster
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Address
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University of Liège
CHU Sart Tilman Bat B23
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City/town
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Liege
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Zip/Postcode
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4000
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Country
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Belgium
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Sponsor
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Nutraveris (France)
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Address
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Nutraveris
18 C, rue du Sabot
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City/town
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Ploufragan
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Zip/Postcode
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22440
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Country
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France
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Date applied
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01/02/2010
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Last edited
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22/02/2010
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Date ISRCTN assigned
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22/02/2010
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