- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01469507
Efficacy and Safety Study in Patients Suffering From Knee Osteoarthritis (VESTA)
Comparative Study of Efficacy and Safety of Three Intra Articular Injections of V0220 Versus Hyalgan® in Patients Suffering From Symptomatic Knee Osteoarthritis. A Multinational Multicentric, Randomised, Double-blind, Parallel-group Study
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").
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: V0220
|
3 weekly injections
|
ACTIVE_COMPARATOR: Hyaluronan
|
3 weekly injections
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain relief assessed on a global pain Visual Analogic Scale
Time Frame: change from baseline over 24 weeks
|
change from baseline over 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Functional improvement (questionnaire)
Time Frame: change from baseline over 24 weeks
|
change from baseline over 24 weeks
|
Patient's and investigator's global assessment of the disease status (Visual Analogic Scale )
Time Frame: change from baseline over 24 weeks
|
change from baseline over 24 weeks
|
Patient's health related quality of life (questionnaire)
Time Frame: over 24 weeks
|
over 24 weeks
|
Consumption of analgesic medication (paracetamol and NSAIDs)(number of days and quantity)
Time Frame: over 24 weeks
|
over 24 weeks
|
Medico-economic questionnaire
Time Frame: over 24 weeks
|
over 24 weeks
|
Occurrence of adverse events
Time Frame: over 24 weeks
|
over 24 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Emmanuel MAHEU, Dr, private practice / unaffiliated
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- V00220 IA 0 01
- 2011-002295-17 (EUDRACT_NUMBER)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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