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Clinical Trials/NCT00556608
NCT00556608CompletedPhase 4

Efficacy Evaluation of Intra-articular Hyaluronic Acid (Sinovial®) vs Synvisc® in the Treatment of Symptomatic Knee Osteoarthritis. A Double-blind, Controlled, Randomised, Parallel-group Non-inferiority Study

IBSA Institut Biochimique SA20 sites in 6 countries381 target enrollmentStarted: November 1, 2007Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
381
Locations
20
Primary Endpoint
Improvement in WOMAC pain subscore from baseline
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this study is to prove the non-inferiority of the intra-articular injection of hyaluronic acid (Sinovial®) in the symptomatic treatment of knee OA in comparison to Synvisc®.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
40 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Age between 40 and 80 years
  • •Primary knee OA of the medial or lateral femoro-tibial compartment
  • •Symptoms for at least 3 months
  • •Diagnosis according to ACR criteria
  • •Kellgren & Lawrence radiological grade 2-3
  • •Patients who failed to respond sufficiently (not responders) to analgesics and/or NSAIDs taken regularly or responders intolerant to the regular use of analgesics and/or NSAIDs.
  • •Mean WOMAC pain subscore at the target knee >= 40 mm and < 80 mm on a VAS at baseline after wash-out from analgesics/NSAIDs· If bilateral knee OA: definition of the most symptomatic joint at screening based on patient's evaluation and Investigator's clinical judgment and mean WOMAC pain subscore at baseline in the contra-lateral knee < 30 mm
  • •Written informed consent
  • •Subject able to understand, co-operative and reliable

Exclusion Criteria

  • •BMI >= 32 kg/m2
  • •Secondary (post-traumatic) knee OA
  • •Predominantly patello-femoral pain/syndrome
  • •No remaining joint space width
  • •Symptomatic hip OA or other interfering health condition
  • •Severe varus/valgus deformity (>15°)
  • •History/present evidence of (target knee): inflammatory, infective or metabolic joint diseases; recurrent clinical chondrocalcinosis; crystal arthropaties; osteo-articular pathologies differing from arthrosis; articular fracture; ochronosis; acromegaly; haemochromatosis; Wilson's disease; primary osteochondromatosis; heritable disorders; collagen gene mutations.
  • •Concomitant rheumatic disease
  • •Significant injury to the target knee in the last 6 months
  • •Previous joint replacement/arthroplasty (target knee)
  • •Arthroscopy/osteotomy/surgery in the past 1 year (target knee)
  • •Any surgery scheduled in the next 6 months
  • •Venous or lymphatic stasis in the relevant limb
  • •Skin infection/disease/trauma at the injection site
  • •Systemic or i.a. (target knee) corticosteroids in the past 3 months
  • •I.a. corticosteroids (non-target joint) in the past 4 weeks
  • •Viscosupplementation (target knee) in the past year
  • •Recently started (in the last 3 months) physical therapy (target knee)
  • •Recently (in the last 3 months) started therapy or change in dosage of SYSADOAs
  • •Ongoing anticoagulant therapy
  • •Chronic or recurrent use of NSAIDs/analgesics/narcotics because of diseases different from OA of the target knee
  • •History of allergy or hypersensitivity to hyaluronic acid or paracetamol or avian proteins
  • •Participation in a clinical study in the last 3 months
  • •Pregnant or lactating women, and women of childbearing potential not willing to use adequate contraception
  • •Patients unable to stay in the study for 6 months, non-cooperating, not able to understand

Arms & Interventions

Sinovial

Experimental

3 intra-articular injections of Sinovial®

Intervention: Sinovial® (syringe containing sodium hyaluronate solution) (Device)

Sinvisc

Active Comparator

Intervention: Synvisc® ( syringe containing Hylan G-F 20 solution) (Device)

Outcomes

Primary Outcomes

Improvement in WOMAC pain subscore from baseline

Time Frame: to week 26

Secondary Outcomes

  • Change in WOMAC OA Index total score and pain, function and stiffness subscores;Change in Lequesne's algofunctional index; Change in global pain (visit assessment); Change in global status by the patient;Change in global status by the Investigator;SPID%(26 weeks)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (20)

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