A Phase 3 interventional study of ASU in Hip Osteoarthritis, sponsored by Laboratoires Expanscience S.A.. Completed at 1 site in France. Open to participants aged 45 Years to 75 Years. Per ClinicalTrials.gov, last updated 2010-02-04.
Sponsored by Laboratoires Expanscience S.A. · Phase 3 and Interventional
This study aims to assess the long term (three years) ability of ASU (Avocado Soya unsaponifiable) to slow the decrease of radiographic JSW (Joint Space Width) in hip osteoarthritis (OA). This is a randomized, double blind, comparative, parallel group study versus placebo.
Inclusion criteria:
Primary hip OA, fulfilling ACR criteria, patient over 45 y, painful > 1 year, Lequesne's index > or equal to 3, with minimum JSW at the target hip > 1 mm and \< 4 mm on pelvic radiograph.
Primary criterion of efficacy:
The main criterion of efficacy is the change of JSW between baseline and end point. JSW is measured on the narrowest joint on pelvic or target hip X ray by blinded reader.
Randomisation is stratified according JSW at baseline (\< 2,5 mm or > or equal to 2,5 mm).
Statistical analysis:
The Full Analysis Set (FAS) is defined by patients with at least one baseline value and one post baseline value.
The main analysis is scheduled on FAS using a Missing At Random (MAR)with a multiple model repeated measure (MMRM)to take in account missing value.
SAP (Statistical Analysis Plan) schedule to analyse JSW change as quantitative variable using an ANCOVA and as qualitative variable (progressors defined as JSW loss upper than 0,5 mm) using Mantel Haentzel test.
642 studies on the registry are indexed under Osteoarthritis, Hip; 122 are open to participants now.
Browse Osteoarthritis, Hip studies →Laboratoires Expanscience S.A. is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Drug: ASU
The main criterion of efficacy is the change of JSW between baseline and end point. JSW is measured on the narrowest joint on pelvic or target hip X ray by blinded reader.
The record gives a start of Dec 1999, a primary completion of Sep 2006 and a completion of Sep 2006. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Feb 2010. You cannot join it, but the record below documents what was studied.
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Laboratoires Expanscience S.A.