NCT03200288

Brief Summary

This is a study to evaluate the Clinical Performance and Safety of a single intra-articular (i.a.) injection of hyaluronic acid product (as HL-01) in the treatment of pain due to osteoarthritis (OA) of the knee.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
692

participants targeted

Target at P75+ for phase_3 knee-osteoarthritis

Timeline
Completed

Started Jun 2017

Geographic Reach
5 countries

31 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 27, 2017

Completed
2 days until next milestone

Study Start

First participant enrolled

June 29, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2018

Completed
Last Updated

November 16, 2021

Status Verified

February 1, 2019

Enrollment Period

12 months

First QC Date

June 21, 2017

Last Update Submit

November 15, 2021

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Change in VAS (Visual Analogue Scale) pain score

    The primary efficacy variable will be the change from baseline of the VAS pain score calculated as a VAS measure ranging from 0 to 100 mm. A four- step analysis will be followed in order to assess superiority of HL-01 versus Placebo after 6, 12, 18 and 24 weeks.

    Baseline-week 24

Secondary Outcomes (5)

  • Change in Lequesne's Algofunctional Index

    Baseline-Week 24

  • Change in global status assessed by subject (EQ-5D-5L EuroQol Group Health questionnaire)

    Baseline-Week 24

  • Change in global status assessed by physician

    Baseline -Week 24

  • Overall response rate according to OMERACT (Outcome Measures in Rheumatology)-OARSI (Osteoarthritis Research Society International) criteria

    Week 6-Week 24

  • Rescue medication usage

    Week 6-Week 24

Other Outcomes (2)

  • Adverse Events

    Screening -Week 24

  • Level of treatment satisfaction

    Baseline-Week 6

Study Arms (2)

HL-01

EXPERIMENTAL

Single 2 ml intra-articular injection of HL-01 (solution of high and low molecular weight hyaluronic acid (HA))

Device: HL-01: high and low molecular weight hyaluronic acid

Placebo

PLACEBO COMPARATOR

Single 2 ml intra-articular injection of Placebo (physiological solution)

Device: Placebo

Interventions

HL-01: high and low molecular weight hyaluronic acidDEVICE

2 ml intra-articular single injection

Also known as: Sinovial HL®
HL-01
PlaceboDEVICE

2 ml intra-articular single injection

Placebo

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female and male subjects ≥40 to 80 years of age.
  • Subjects with primary knee OA of the medial or lateral femoro-tibial compartment, documented according to ACR criteria with symptoms, at screening, from at least 3 months.
  • Subjects with Kellgren \& Lawrence (K-L) radiological grade 2-3.
  • Subjects with at least one antero-posterior view X-Ray image of the target knee taken within 12 months prior to the screening.
  • Subjects with OA pain intensity meeting the criteria below:
  • If unilateral knee OA: Subjects demonstrating at screening pain intensity in the target knee measured by Visual Analogue Scale (VAS) ≥40 mm VAS, and ≤ 20 mm in the contralateral knee and confirmed at randomization after wash-out from analgesics/NSAIDs.
  • If bilateral knee OA: definition of the most symptomatic joint at screening based on subject's evaluation and Investigator's clinical judgment with subjects demonstrating pain intensity in the target knee measured by Visual Analogue Scale (VAS) ≥40 mm VAS, and ≤ 20mm in the contralateral knee and confirmed at randomization after wash-out from analgesics/NSAIDs.
  • Subjects are able to understand and are willing and able to comply with study procedures including usage of acetaminophen as the only analgesic.
  • Subjects are able to provide informed consent.
  • Any female subject of childbearing potential must agree to use adequate methods of contraception throughout the course of the study.

You may not qualify if:

  • Subjects with secondary (post-traumatic) knee OA of the target and non-target joints.
  • Subjects with K-L radiological grade 4 knee OA.
  • Subjects with a history of knee joint replacement/arthroplasty of the target knee.
  • Subjects with a history of arthroscopy, osteotomy, or surgery of the target knee in the past 12 months.
  • Subjects with any significant injury to the target knee in the last 6 months (as per Investigator judgment).
  • Subjects with Body Mass Index (BMI) ≥32 kg/m2.
  • Subjects with any musculoskeletal condition affecting the target knee that would impair proper assessment of the Investigational Medicinal Device (IMD) performance in the target knee as assessed by the Investigator and such as:
  • severe varus/valgus deformity (\>15°)
  • predominantly patello-femoral pain/syndrome.
  • Subjects with a history of symptomatic hip OA or other health condition i.e. associated with pain and interfering with adequate study endpoints evaluation.
  • Subjects with a known history or present evidence of conditions which may affect the target knee assessments, like rheumatic disease and inflammatory, infective or metabolic joint diseases; recurrent clinical chondrocalcinosis; crystal arthropathies; osteo-articular pathologies differing from arthrosis; articular fracture; ochronosis; acromegaly; haemochromatosis; Wilson's disease; primary osteochondromatosis; heritable disorders; collagen gene mutations.
  • Subjects with venous or lymphatic stasis in the relevant limb.
  • Subjects with a history of the following treatments for knee OA:
  • a) I. a. knee corticosteroids: i. target knee - in the past 3 months ii. non-target knee/other joints - in the past 4 weeks b) Systemic (both oral and parenteral) and topical corticosteroids at the target knee in the past 3 months.
  • c) Topical anti-inflammatories and analgesics applied at the target knee in the past 48 hrs.
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (31)

CHU Centre Ville (Brull) - Bone Metabolism Unit

Liège, Belgium

Location

Rheumazentrum Prof. Dr. med. Gunther Neeck

Bad Doberan, Germany

Location

Klinische Forschung Berlin-Mitte GmbH

Berlin, Germany

Location

DGS Schmerzzentrum Eichstätt

Eichstätt, Germany

Location

AmBeNet GmbHDas Ambulante BehandlungsNetz

Leipzig, Germany

Location

Revita Rendelő

Budapest, Hungary

Location

Semmelweis Egyetem - Ortopediai Klinika

Budapest, Hungary

Location

Szent Margit Rendelőintézet

Budapest, Hungary

Location

DEEK University

Debrecen, Hungary

Location

MEDIDEA Egeszsegugyi es Szolgaltato Beteti Tarsasag

Kiskunfélegyháza, Hungary

Location

Swan Med SMO

Létavértes, Hungary

Location

Istituto Ortopedico Gaetano Pini

Milan, Italy

Location

Fisiatria Policlinico di Napoli

Napoli, Italy

Location

Ospedale San Pietro - FATEBENEFRATELLI

Roma, Italy

Location

NZOZ VITAMED Gałaj i Cichomski Sp. j.

Bydgoszcz, Poland

Location

ETG Chełm

Chełm, Poland

Location

Centrum Medyczne Lukamed

Chojnice, Poland

Location

Centrum Kliniczno-Badawcze

Elblag, Poland

Location

Gdańskie Centrum Zdrowia

Gdansk, Poland

Location

ETG Łódź

Lodz, Poland

Location

Klinika Zdrowej Kości

Lodz, Poland

Location

ETG Lublin

Lublin, Poland

Location

SOLB - Zbigniew Zegota

Ostróda, Poland

Location

ETG Siedlce

Siedlce, Poland

Location

RCMed

Sochaczew, Poland

Location

Lubelskie Centrum Diagnostyczne

Świdnik, 21-040, Poland

Location

ETG Warszawa

Warsaw, Poland

Location

Europejskie Centrum Leczenia Chorób Cywilizacyjnych

Warsaw, Poland

Location

NZOZ Wilmed

Warsaw, Poland

Location

Wasilczyk Medical Clinic Indywidualna Praktyka Lekarska Cezary Wasilczyk

Warsaw, Poland

Location

ETG Zamość

Zamość, Poland

Location

Related Publications (2)

  • Migliore A, Blicharski T, Plebanski R, Zegota Z, Gyula G, Rannou F, Reginster JY. Knee Osteoarthritis Pain Management with an Innovative High and Low Molecular Weight Hyaluronic Acid Formulation (HA-HL): A Randomized Clinical Trial. Rheumatol Ther. 2021 Dec;8(4):1617-1636. doi: 10.1007/s40744-021-00363-3. Epub 2021 Aug 30.

    PMID: 34462887DERIVED

  • Bruyere O, Dardenne N, Donneau AF, Reginster JY. Responder Profile to Pharmaceutical-Grade Chondroitin Sulfate: An Analysis of the CONCEPT Trial. Adv Ther. 2020 Nov;37(11):4641-4648. doi: 10.1007/s12325-020-01484-x. Epub 2020 Sep 21.

    PMID: 32954487DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
During the course of the study only the physicians who will perform the intra-articular injection (injectors) will be unblinded. All the other physicians (assessors) and study participants will be blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2017

First Posted

June 27, 2017

Study Start

June 29, 2017

Primary Completion

June 27, 2018

Study Completion

October 30, 2018

Last Updated

November 16, 2021

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

HU(6)IT(3)PL(17)BE(1)DE(4)