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

Hip Osteoarthritis Clinical Trial

— ERADIAS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01062737
• Other study ID #: PR 2898
• Status: Completed
• Phase: Phase 3
• First received: February 3, 2010
• Last updated: February 3, 2010
• Start date: December 1999
• Est. completion date: September 2006

Study information

• Verified date: February 2010
• Source: Laboratoires Expanscience S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: September 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 75 Years

Eligibility

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.

Study Design

N/A

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Hip

Intervention

Drug:
• ASU

Locations

Country	Name	City	State
France	Multiple locations	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Laboratoires Expanscience S.A.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.