NCT01062737

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Dec 1999

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1999

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

February 3, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 4, 2010

Completed
Last Updated

February 4, 2010

Status Verified

February 1, 2010

Enrollment Period

6.8 years

First QC Date

February 3, 2010

Last Update Submit

February 3, 2010

Conditions

Hip Osteoarthritis

Outcome Measures

Primary Outcomes (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.

Study Arms (1)

ASU (Avocado Soybean Unsaponifiable)

EXPERIMENTAL
Drug: ASU

Interventions

ASUDRUG
ASU (Avocado Soybean Unsaponifiable)

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • secondary OA.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Multiple locations

Paris, France

Location

Related Publications (1)

  • Maheu E, Cadet C, Marty M, Moyse D, Kerloch I, Coste P, Dougados M, Mazieres B, Spector TD, Halhol H, Grouin JM, Lequesne M. Randomised, controlled trial of avocado-soybean unsaponifiable (Piascledine) effect on structure modification in hip osteoarthritis: the ERADIAS study. Ann Rheum Dis. 2014 Feb;73(2):376-84. doi: 10.1136/annrheumdis-2012-202485. Epub 2013 Jan 23.

    PMID: 23345601DERIVED

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
phase 3
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 3, 2010

First Posted

February 4, 2010

Study Start

December 1, 1999

Primary Completion

September 1, 2006

Study Completion

September 1, 2006

Last Updated

February 4, 2010

Record last verified: 2010-02

Locations

FR(1)