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

This study has been completed.
Information provided by:
Laboratoires Expanscience S.A. Identifier:
First received: February 3, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
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 Intervention Phase
Hip Osteoarthritis
Drug: ASU
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:

Further study details as provided by Laboratoires Expanscience S.A.:

Primary Outcome Measures:
  • 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.

Study Start Date: December 1999
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ASU (Avocado Soybean Unsaponifiable) Drug: ASU

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.


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

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.
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Please refer to this study by its identifier: NCT01062737

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Pr Michel Lequesne, Principal investigator Identifier: NCT01062737     History of Changes
Other Study ID Numbers: PR 2898
Study First Received: February 3, 2010
Last Updated: February 3, 2010

Additional relevant MeSH terms:
Osteoarthritis, Hip
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases processed this record on May 25, 2017