MedTrace Logo

Efficacy Study of Intra-articular Hyaluronic Acid in the Knee Osteoarthritis

NCT00556608 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 381

Last updated 2012-12-04

No results posted yet for this study

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®.

Conditions

  • Osteoarthritis, Knee

Interventions

DEVICE

Sinovial® (syringe containing sodium hyaluronate solution)

2 mL 0.8% sodium hyaluronate (16 mg) solution. 3 intra-articular injections once-a-week.

DEVICE

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

2 mL 0.8% Hylan G-F 20 (16 mg) solution. 3 intra-articular injections once-a-week.

Sponsors & Collaborators

  • IBSA Institut Biochimique SA

    lead INDUSTRY

Principal Investigators

  • Karel PAVELKA, MD · Institute of Rheumatology-Na Slupi 4 - 12850 Praha 2 (Czech Republic)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2009-07-31
Completion
2010-05-31

Countries

  • Czechia
  • France
  • Germany
  • Italy
  • Slovakia
  • Switzerland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00556608 on ClinicalTrials.gov