Efficacy and Safety Study in Patients Suffering From Knee Osteoarthritis

NCT01469507 | Withdrawn

• 2 other identifiers: V00220 IA 0 012011-002295-17
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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").

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Pain relief assessed on a global pain Visual Analogic Scale

  change from baseline over 24 weeks

Secondary Outcomes (6)

• Functional improvement (questionnaire)

  change from baseline over 24 weeks

• Patient's and investigator's global assessment of the disease status (Visual Analogic Scale )

  change from baseline over 24 weeks

• Patient's health related quality of life (questionnaire)

  over 24 weeks

• Consumption of analgesic medication (paracetamol and NSAIDs)(number of days and quantity)

  over 24 weeks

• Medico-economic questionnaire

  over 24 weeks

Study Arms (2)

V0220

EXPERIMENTAL

Device: Chondroitin sulfate and sodium hyaluronate

Hyaluronan

ACTIVE COMPARATOR

Drug: Hyaluronan

Interventions

Chondroitin sulfate and sodium hyaluronate DEVICE

3 weekly injections

V0220

Hyaluronan DRUG

3 weekly injections

Also known as: Hyalgan®

Hyaluronan

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pierre Fabre Medicament: lead

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Emmanuel MAHEU, Dr

  private practice / unaffiliated

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2011
• First Posted: November 10, 2011
• Last Updated: February 21, 2013

Record last verified: 2013-02