To Assess the Safety and Effectiveness of Hyruan ONE Versus a Comparator for the Treatment of Knee Osteoarthritis in Europe

March 15, 2022 updated by: LG Chem

A Prospective, Active Controlled, Randomised, Parallel Group, Double Blind, Multicentre Study to Assess the Safety and Effectiveness of Hyruan ONE Versus a Comparator for the Treatment of Knee Osteoarthritis in Europe

To Assess the Safety and Effectiveness of Hyruan ONE versus a Comparator for the Treatment of Knee Osteoarthritis in Europe

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

284

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Świdnik, Poland, 21-040
        • Lubelskie Centrum Diagnostyczne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subject is ≥40 years old.
  2. Subject has radiographic evidence of mild-to-moderate OA (Kellgren Lawrence Scale grade II III) in one or both knees. Radiographs to be taken within 12 months prior to the Screening visit.
  3. Subject has OA pain in the target knee despite conservative physical treatments and/or analgesics.

Exclusion Criteria:

  1. Subject has rheumatoid arthritis or other inflammatory metabolic arthritis.
  2. Subject has a documented history of hypersensitivity to HA.
  3. Subject has a documented infection or severe inflammation of the target knee joint.
  4. Subject has a skin disease in the area of the injection site.
  5. Subject has a clinically apparently tense effusion of the target knee on examination determined by either a positive bulge sign or positive ballottement of the patella (patellar tap).
  6. Subject has chronic pain requiring chronic ongoing analgesic therapy that confounds the measurement of pain in the target knee.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hyruan ONE®
Device: Hyruan ONE®
For use as a symptomatic treatment of osteoarthritis (OA) of the knee
Active Comparator: Durolane®
Device: Durolane®
For use as a symptomatic treatment of osteoarthritis (OA) of the knee

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change in the WOMAC(Western Ontario and McMaster Universities Osteoarthritis Index) Likert pain subscore
Time Frame: from Baseline to 13 weeks post injection.

The WOMAC Likert Index measures 3 separate dimensions: pain, stiffness, and function. The subject will self assess the level of pain in the target knee joint for the prior 48 hours (5 questions), the level of difficulty of performing daily activities (17 questions), and the level of stiffness (2 questions) using the WOMAC Likert Questionnaire (24 total questions; 4 points/question).

Each item of the WOMAC Likert Index will be assessed using the scale of 0=none, 1=a little, 2=moderate, 3=severe, 4=very severe. The aggregate total score that can result for each scale is as follows:

Pain = 0-20 Stiffness = 0-8 Physical function = 0-68.
from Baseline to 13 weeks post injection.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LG Chem

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2021

Primary Completion (Actual)

June 11, 2021

Study Completion (Actual)

December 7, 2021

Study Registration Dates

First Submitted

January 7, 2021

First Submitted That Met QC Criteria

January 28, 2021

First Posted (Actual)

February 1, 2021

Study Record Updates

Last Update Posted (Actual)

March 16, 2022

Last Update Submitted That Met QC Criteria

March 15, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LG-HACL026

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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