Efficacy and Safety Study in Patients Suffering From Knee Osteoarthritis (VESTA)

Pierre Fabre

Status

Withdrawn

Conditions

Knee Osteoarthritis

Treatments

Device: Chondroitin sulfate and sodium hyaluronate

Drug: Hyaluronan

Study type

Interventional

Funder types

Industry

Identifiers

NCT01469507

2011-002295-17 (EudraCT Number)

V00220 IA 0 01

Details and patient eligibility

About

The primary objective of this study is to compare a combination of hyaluronic acid and chondroitin sulfate (V0220) to Hyalgan® on pain relief in patients with symptomatic knee osteoarthritis (OA) over 24 weeks when administered in three weekly injections.

Chondroitin sulfate is one of the components of cartilage. Studies have shown that chondroitin sulphate improves the quality of the hyaluronic acid produced in the joint. The benefit of V0220 combination is based on two main physicochemical properties, in line with the characteristics of osteoarthritic disease: optimising the rheological behaviour and improving the buffering effect on synovial flow ("outflow buffering").

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

presenting with uni or bilateral medial and/or lateral femorotibial osteoarthritis of the knee evolving for more than 6 months
patients taking analgesic medications for at least 3 months prior to randomisation and dissatisfied with their current therapy

Exclusion criteria

isolated symptomatic femoropatellar osteoarthritis
target knee prothesis
having undergone an articular lavage, or an arthroscopy or any surgery on the target knee in the 6 months preceding randomisation,
target knee osteoarthritis with clinical joint effusion at selection and at randomization
body mass index (BMI) greater than or equal to 30,
patient having received any corticosteroid treatment by any administration route (other than inhalers, ocular, auricular route) in the month preceding randomisation,
patient having received intra-articular steroid injection in the target knee within the month preceding randomisation or patient having received intra-articular hyaluronic acid in the target knee in the 6 months preceding randomisation