Efficacy and Safety Study in Patients Suffering From Knee Osteoarthritis
Not Applicable
Withdrawn
- Conditions
- Knee Osteoarthritis
- Interventions
- Device: Chondroitin sulfate and sodium hyaluronate
- Registration Number
- NCT01469507
- Lead Sponsor
- Pierre Fabre Medicament
- 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").
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description V0220 Chondroitin sulfate and sodium hyaluronate - Hyaluronan Hyaluronan -
- Primary Outcome Measures
Name Time Method Pain relief assessed on a global pain Visual Analogic Scale change from baseline over 24 weeks
- Secondary Outcome Measures
Name Time Method Functional improvement (questionnaire) change from baseline over 24 weeks Patient's and investigator's global assessment of the disease status (Visual Analogic Scale ) change from baseline over 24 weeks Patient's health related quality of life (questionnaire) over 24 weeks Consumption of analgesic medication (paracetamol and NSAIDs)(number of days and quantity) over 24 weeks Medico-economic questionnaire over 24 weeks Occurrence of adverse events over 24 weeks