Clinical trial NCT01469507: Efficacy and Safety Study in Patients Suffering From Knee Osteoarthritis
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Pierre Fabre Medicament
Sponsor class: INDUSTRY
First posted: 2011-11-10
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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").


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

Primary outcomes:
measure: Pain relief assessed on a global pain Visual Analogic Scale
timeFrame: change from baseline over 24 weeks
Secondary outcomes:
measure: Functional improvement (questionnaire)
timeFrame: change from baseline over 24 weeks
measure: Patient's and investigator's global assessment of the disease status (Visual Analogic Scale )
timeFrame: change from baseline over 24 weeks
measure: Patient's health related quality of life (questionnaire)
timeFrame: over 24 weeks
measure: Consumption of analgesic medication (paracetamol and NSAIDs)(number of days and quantity)
timeFrame: over 24 weeks
measure: Medico-economic questionnaire
timeFrame: over 24 weeks
measure: Occurrence of adverse events
timeFrame: over 24 weeks
Other outcomes:
Locations:
Study officials:
affiliation: private practice / unaffiliated
name: Emmanuel MAHEU, Dr
role: PRINCIPAL_INVESTIGATOR
References: