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Efficacy of OSTENIL PLUS (Hyaluronic Acid) Versus SYNVISC-ONE in Patients With Tibiofemoral Osteoarthritis

NCT03203408 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 290

Last updated 2017-10-11

No results posted yet for this study

Summary

The main objective of the study was to demonstrate the non-inferiority of the efficacy of a single intra-articular injection of OSTENIL PLUS compared to that of a single intra-articular injection of the reference product SYNVISC-ONE in the treatment of symptomatic tibiofemoral osteoarthritis. The primary endpoint was the change in mean score on the WOMAC pain scales from D0 to D180.

Conditions

Interventions

DEVICE

OSTENIL PLUS

Injection into the joint cavity of the most painful knee

DEVICE

SYNVISC-ONE

Injection into the joint cavity of the most painful knee

Sponsors & Collaborators

  • TRB Chemedica

    lead INDUSTRY

Principal Investigators

  • Renée Liliane Dreiser, Dr · APHP Bichat-Claude Bernard, Paris, France

  • Bernard Avouac, Dr · APHP Henri Mondor, Creteil, France

  • Thomas Bardin, Prof. · APHP Lariboisière, Paris, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-06-21
Primary Completion
2012-11-22
Completion
2012-11-22

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Entities

Diseases

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 NCT03203408 on ClinicalTrials.gov