Efficacy and Safety Study in Patients Suffering From Knee Osteoarthritis

NCT ID: NCT01469507

Last Updated: 2013-02-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL

Brief Summary

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").

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

V0220

Group Type: EXPERIMENTAL

Chondroitin sulfate and sodium hyaluronate

Intervention Type: DEVICE

3 weekly injections

Hyaluronan

Group Type: ACTIVE_COMPARATOR

Hyaluronan

Intervention Type: DRUG

3 weekly injections

Interventions

Chondroitin sulfate and sodium hyaluronate

3 weekly injections

Intervention Type: DEVICE

Hyaluronan

3 weekly injections

Intervention Type: DRUG

Other Intervention Names

Hyalgan®

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pierre Fabre Medicament

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emmanuel MAHEU, Dr

Role: PRINCIPAL_INVESTIGATOR

private practice / unaffiliated

Other Identifiers

2011-002295-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

V00220 IA 0 01

Identifier Type: -

Identifier Source: org_study_id