Efficacy and Safety Study in Patients Suffering From Knee Osteoarthritis (VESTA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01469507
Recruitment Status : Withdrawn
First Posted : November 10, 2011
Last Update Posted : February 21, 2013
Information provided by (Responsible Party):
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").

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Device: Chondroitin sulfate and sodium hyaluronate Drug: Hyaluronan Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: V0220 Device: Chondroitin sulfate and sodium hyaluronate
3 weekly injections
Active Comparator: Hyaluronan Drug: Hyaluronan
3 weekly injections
Other Name: Hyalgan®

Primary Outcome Measures :
  1. Pain relief assessed on a global pain Visual Analogic Scale [ Time Frame: change from baseline over 24 weeks ]

Secondary Outcome Measures :
  1. Functional improvement (questionnaire) [ Time Frame: change from baseline over 24 weeks ]
  2. Patient's and investigator's global assessment of the disease status (Visual Analogic Scale ) [ Time Frame: change from baseline over 24 weeks ]
  3. Patient's health related quality of life (questionnaire) [ Time Frame: over 24 weeks ]
  4. Consumption of analgesic medication (paracetamol and NSAIDs)(number of days and quantity) [ Time Frame: over 24 weeks ]
  5. Medico-economic questionnaire [ Time Frame: over 24 weeks ]
  6. Occurrence of adverse events [ Time Frame: over 24 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01469507

Sponsors and Collaborators
Pierre Fabre Medicament
Principal Investigator: Emmanuel MAHEU, Dr private practice / unaffiliated

Responsible Party: Pierre Fabre Medicament Identifier: NCT01469507     History of Changes
Other Study ID Numbers: V00220 IA 0 01
2011-002295-17 ( EudraCT Number )
First Posted: November 10, 2011    Key Record Dates
Last Update Posted: February 21, 2013
Last Verified: February 2013

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Protective Agents