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Evaluation of the Structure Modifying Effect of Avocado-Soybean Unsaponifiables in Hip Osteoarthritis (ERADIAS)

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ClinicalTrials.gov Identifier: NCT01062737
Recruitment Status : Completed
First Posted : February 4, 2010
Last Update Posted : February 4, 2010
Sponsor:
Information provided by:
Laboratoires Expanscience S.A.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hip Osteoarthritis Drug: ASU Phase 3

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Official Title: Evaluation of the Structure-modifying Effect and Safety of Avocado-Soybean Unsaponifiable (Piascledine 300) in Hip Osteoarthritis (OA) a 3 Years Multicenter Randomized, Double Blind, Placebo Controlled Trial
Study Start Date : December 1999
Actual Primary Completion Date : September 2006
Actual Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: ASU (Avocado Soybean Unsaponifiable) Drug: ASU



Primary Outcome Measures :
  1. 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.


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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • primary OA of hip,
  • ACR criteria,
  • older than 45 years,
  • symptomatic painful > 1 an,
  • Lequesne's index > or equal to 3,
  • JSW between 1 and 4 mm on pelvic radiograph.

Exclusion Criteria:

  • secondary OA.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01062737


Locations
France
Multiple locations
Paris, France
Sponsors and Collaborators
Laboratoires Expanscience S.A.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pr Michel Lequesne, Principal investigator
ClinicalTrials.gov Identifier: NCT01062737     History of Changes
Other Study ID Numbers: PR 2898
First Posted: February 4, 2010    Key Record Dates
Last Update Posted: February 4, 2010
Last Verified: February 2010

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases