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

February 20, 2013 updated by: Pierre Fabre Medicament

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

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").

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain relief assessed on a global pain Visual Analogic Scale
Time Frame: change from baseline over 24 weeks
change from baseline over 24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Functional improvement (questionnaire)
Time Frame: change from baseline over 24 weeks
change from baseline over 24 weeks
Patient's and investigator's global assessment of the disease status (Visual Analogic Scale )
Time Frame: change from baseline over 24 weeks
change from baseline over 24 weeks
Patient's health related quality of life (questionnaire)
Time Frame: over 24 weeks
over 24 weeks
Consumption of analgesic medication (paracetamol and NSAIDs)(number of days and quantity)
Time Frame: over 24 weeks
over 24 weeks
Medico-economic questionnaire
Time Frame: over 24 weeks
over 24 weeks
Occurrence of adverse events
Time Frame: over 24 weeks
over 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pierre Fabre Medicament

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 7, 2011

First Submitted That Met QC Criteria

November 8, 2011

First Posted (ESTIMATE)

November 10, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

February 21, 2013

Last Update Submitted That Met QC Criteria

February 20, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V00220 IA 0 01
  • 2011-002295-17 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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