Back to resultsTo Assess the Safety and Effectiveness of Hyruan ONE Versus a Comparator for the Treatment of Knee Osteoarthritis in Europe
Primary Purpose
Osteoarthritis (OA) of the Knee
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Hyruan ONE®
Durolane®
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis (OA) of the Knee
Eligibility Criteria
Inclusion Criteria:
- Subject is ≥40 years old.
- 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.
- Subject has OA pain in the target knee despite conservative physical treatments and/or analgesics.
Exclusion Criteria:
- Subject has rheumatoid arthritis or other inflammatory metabolic arthritis.
- Subject has a documented history of hypersensitivity to HA.
- Subject has a documented infection or severe inflammation of the target knee joint.
- Subject has a skin disease in the area of the injection site.
- 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).
- Subject has chronic pain requiring chronic ongoing analgesic therapy that confounds the measurement of pain in the target knee.
Sites / Locations
- Lubelskie Centrum Diagnostyczne
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Hyruan ONE®
Durolane®
Arm Description
Outcomes
Primary Outcome Measures
The change in the WOMAC(Western Ontario and McMaster Universities Osteoarthritis Index) Likert pain subscore
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04732793
Brief Title
To Assess the Safety and Effectiveness of Hyruan ONE Versus a Comparator for the Treatment of Knee Osteoarthritis in Europe
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
February 3, 2021 (Actual)
Primary Completion Date
June 11, 2021 (Actual)
Study Completion Date
December 7, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LG Chem
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To Assess the Safety and Effectiveness of Hyruan ONE versus a Comparator for the Treatment of Knee Osteoarthritis in Europe
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis (OA) of the Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
284 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hyruan ONE®
Arm Type
Experimental
Arm Title
Durolane®
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Hyruan ONE®
Intervention Description
For use as a symptomatic treatment of osteoarthritis (OA) of the knee
Intervention Type
Device
Intervention Name(s)
Durolane®
Intervention Description
For use as a symptomatic treatment of osteoarthritis (OA) of the knee
Primary Outcome Measure Information:
Title
The change in the WOMAC(Western Ontario and McMaster Universities Osteoarthritis Index) Likert pain subscore
Description
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.
Time Frame
from Baseline to 13 weeks post injection.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject is ≥40 years old.
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.
Subject has OA pain in the target knee despite conservative physical treatments and/or analgesics.
Exclusion Criteria:
Subject has rheumatoid arthritis or other inflammatory metabolic arthritis.
Subject has a documented history of hypersensitivity to HA.
Subject has a documented infection or severe inflammation of the target knee joint.
Subject has a skin disease in the area of the injection site.
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).
Subject has chronic pain requiring chronic ongoing analgesic therapy that confounds the measurement of pain in the target knee.
Facility Information:
Facility Name
Lubelskie Centrum Diagnostyczne
City
Świdnik
ZIP/Postal Code
21-040
Country
Poland
12. IPD Sharing Statement
Learn more about this trial
To Assess the Safety and Effectiveness of Hyruan ONE Versus a Comparator for the Treatment of Knee Osteoarthritis in Europe
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