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

Osteoarthritis (OA) of the Knee Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04732793
• Other study ID #: LG-HACL026
• Status: Completed
• Phase: N/A
• Start date: February 3, 2021
• Est. completion date: December 7, 2021

Study information

• Verified date: March 2022
• Source: LG Chem
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 284
• Est. completion date: December 7, 2021
• Est. primary completion date: June 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis (OA) of the Knee
• Osteoarthritis, Knee

Intervention

Device:
• Hyruan ONE®
For use as a symptomatic treatment of osteoarthritis (OA) of the knee
• Durolane®
For use as a symptomatic treatment of osteoarthritis (OA) of the knee

Locations

Country	Name	City	State
Poland	Lubelskie Centrum Diagnostyczne	Swidnik

Sponsors (1)

Lead Sponsor	Collaborator
LG Chem

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	from Baseline to 13 weeks post injection.