Efficacy and Safety Study in Patients Suffering From Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

— 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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01469507
• Other study ID #: V00220 IA 0 01
• Secondary ID: 2011-002295-17
• Status: Withdrawn
• Phase: N/A
• First received: November 7, 2011
• Last updated: February 20, 2013

Study information

• Verified date: February 2013
• Source: Pierre Fabre Medicament
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Spain: Spanish Agency of MedicinesBelgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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").

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Chondroitin sulfate and sodium hyaluronate
3 weekly injections

Drug:
• Hyaluronan
3 weekly injections

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pierre Fabre Medicament

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain relief assessed on a global pain Visual Analogic Scale		change from baseline over 24 weeks	No
Secondary	Functional improvement (questionnaire)		change from baseline over 24 weeks	No
Secondary	Patient's and investigator's global assessment of the disease status (Visual Analogic Scale )		change from baseline over 24 weeks	No
Secondary	Patient's health related quality of life (questionnaire)		over 24 weeks	No
Secondary	Consumption of analgesic medication (paracetamol and NSAIDs)(number of days and quantity)		over 24 weeks	No
Secondary	Medico-economic questionnaire		over 24 weeks	No
Secondary	Occurrence of adverse events		over 24 weeks	Yes