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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Pierre Fabre Medicament
ClinicalTrials.gov Identifier:
NCT01469507
First received: November 7, 2011
Last updated: February 20, 2013
Last verified: February 2013
  Purpose

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 Intervention
Knee Osteoarthritis
Device: Chondroitin sulfate and sodium hyaluronate
Drug: Hyaluronan

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 NLM:


Further study details as provided by Pierre Fabre Medicament:

Primary Outcome Measures:
  • Pain relief assessed on a global pain Visual Analogic Scale [ Time Frame: change from baseline over 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Functional improvement (questionnaire) [ Time Frame: change from baseline over 24 weeks ] [ Designated as safety issue: No ]
  • Patient's and investigator's global assessment of the disease status (Visual Analogic Scale ) [ Time Frame: change from baseline over 24 weeks ] [ Designated as safety issue: No ]
  • Patient's health related quality of life (questionnaire) [ Time Frame: over 24 weeks ] [ Designated as safety issue: No ]
  • Consumption of analgesic medication (paracetamol and NSAIDs)(number of days and quantity) [ Time Frame: over 24 weeks ] [ Designated as safety issue: No ]
  • Medico-economic questionnaire [ Time Frame: over 24 weeks ] [ Designated as safety issue: No ]
  • Occurrence of adverse events [ Time Frame: over 24 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 0
Arms Assigned Interventions
Experimental: V0220 Device: Chondroitin sulfate and sodium hyaluronate
3 weekly injections
Active Comparator: Hyaluronan Drug: Hyaluronan
3 weekly injections
Other Name: Hyalgan®

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01469507

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

No publications provided

Responsible Party: Pierre Fabre Medicament
ClinicalTrials.gov Identifier: NCT01469507     History of Changes
Other Study ID Numbers: V00220 IA 0 01, 2011-002295-17
Study First Received: November 7, 2011
Last Updated: February 20, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Spain: Spanish Agency of Medicines
Belgium: Federal Agency for Medicinal Products and Health Products

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

ClinicalTrials.gov processed this record on September 18, 2014