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VESTA: Efficacy and Safety Study in Patients Suffering From Knee Osteoarthritis

Sponsor
Pierre Fabre Medicament (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT01469507
Collaborator
(none)
0
Enrollment
2
Arms

Study Details

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").

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
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

Arms and Interventions

Arm Intervention/Treatment
Experimental: V0220

Device: Chondroitin sulfate and sodium hyaluronate
3 weekly injections
Active Comparator: Hyaluronan

Drug: Hyaluronan
3 weekly injections
Other Names:
  • Hyalgan®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pain relief assessed on a global pain Visual Analogic Scale [change from baseline over 24 weeks]

    Secondary Outcome Measures

    1. Functional improvement (questionnaire) [change from baseline over 24 weeks]

    2. Patient's and investigator's global assessment of the disease status (Visual Analogic Scale ) [change from baseline over 24 weeks]

    3. Patient's health related quality of life (questionnaire) [over 24 weeks]

    4. Consumption of analgesic medication (paracetamol and NSAIDs)(number of days and quantity) [over 24 weeks]

    5. Medico-economic questionnaire [over 24 weeks]

    6. Occurrence of adverse events [over 24 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 80 Years
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Pierre Fabre Medicament

    Investigators

    • Principal Investigator: Emmanuel MAHEU, Dr, private practice / unaffiliated

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Pierre Fabre Medicament
    ClinicalTrials.gov Identifier:
    NCT01469507
    Other Study ID Numbers:
    • V00220 IA 0 01
    • 2011-002295-17
    First Posted:
    Nov 10, 2011
    Last Update Posted:
    Feb 21, 2013
    Last Verified:
    Feb 1, 2013
    Additional relevant MeSH terms:
    Osteoarthritis
    Osteoarthritis, Knee
    Hyaluronic Acid

    Study Results

    No Results Posted as of Feb 21, 2013