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

Primary Purpose

Knee Osteoarthritis

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Chondroitin sulfate and sodium hyaluronate
Hyaluronan
Sponsored by
Pierre Fabre Medicament
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    V0220

    Hyaluronan

    Arm Description

    Outcomes

    Primary Outcome Measures

    Pain relief assessed on a global pain Visual Analogic Scale

    Secondary Outcome Measures

    Functional improvement (questionnaire)
    Patient's and investigator's global assessment of the disease status (Visual Analogic Scale )
    Patient's health related quality of life (questionnaire)
    Consumption of analgesic medication (paracetamol and NSAIDs)(number of days and quantity)
    Medico-economic questionnaire
    Occurrence of adverse events

    Full Information

    First Posted
    November 7, 2011
    Last Updated
    February 20, 2013
    Sponsor
    Pierre Fabre Medicament
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01469507
    Brief Title
    Efficacy and Safety Study in Patients Suffering From Knee Osteoarthritis
    Acronym
    VESTA
    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

    2. Study Status

    Record Verification Date
    February 2013
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Pierre Fabre Medicament

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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").

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Knee Osteoarthritis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    V0220
    Arm Type
    Experimental
    Arm Title
    Hyaluronan
    Arm Type
    Active Comparator
    Intervention Type
    Device
    Intervention Name(s)
    Chondroitin sulfate and sodium hyaluronate
    Intervention Description
    3 weekly injections
    Intervention Type
    Drug
    Intervention Name(s)
    Hyaluronan
    Other Intervention Name(s)
    Hyalgan®
    Intervention Description
    3 weekly injections
    Primary Outcome Measure Information:
    Title
    Pain relief assessed on a global pain Visual Analogic Scale
    Time Frame
    change from baseline over 24 weeks
    Secondary Outcome Measure Information:
    Title
    Functional improvement (questionnaire)
    Time Frame
    change from baseline over 24 weeks
    Title
    Patient's and investigator's global assessment of the disease status (Visual Analogic Scale )
    Time Frame
    change from baseline over 24 weeks
    Title
    Patient's health related quality of life (questionnaire)
    Time Frame
    over 24 weeks
    Title
    Consumption of analgesic medication (paracetamol and NSAIDs)(number of days and quantity)
    Time Frame
    over 24 weeks
    Title
    Medico-economic questionnaire
    Time Frame
    over 24 weeks
    Title
    Occurrence of adverse events
    Time Frame
    over 24 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Emmanuel MAHEU, Dr
    Organizational Affiliation
    private practice / unaffiliated
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Efficacy and Safety Study in Patients Suffering From Knee Osteoarthritis

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