Efficacy and Safety Study in Patients Suffering From Knee Osteoarthritis
NCT01469507 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2013-02-21
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
Interventions
- DEVICE
-
Chondroitin sulfate and sodium hyaluronate
3 weekly injections
- DRUG
-
Hyaluronan
3 weekly injections
Sponsors & Collaborators
-
Pierre Fabre Medicament
lead INDUSTRY
Principal Investigators
-
Emmanuel MAHEU, Dr · private practice / unaffiliated
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
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