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

October 10, 2017 updated by: TRB Chemedica

Efficacy of OSTENIL PLUS (Hyaluronic Acid) Versus SYNVISC-ONE in Patients With Tibiofemoral Osteoarthritis. A Randomised, Controlled, Double-blind, Parallel-group Study With a 6-month Follow-up

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

After a period of washout-out for NSAIDs, the patients received a single intra-articular injection of OSTENIL PLUS or of SYNVISC-ONE in the most painful knee. The study involved a preselection visit at D-7 and five further visits: at D0 (baseline, evaluation before intra-articular injection), at D2 ± 2 days (injection), at D30 ± 15 days, at D90 ± 15 days and C5 at D180 ± 15 days.

To enrol the patients as quickly as possible, 129 sites, i.e. general medical or rheumatology practices, were open. After verifying the inclusion and exclusion criteria, the evaluating investigators assigned a randomisation number based on the chronological order of inclusion of patients at their site. The patient was then sent to the injecting investigator so that he/she could give the injection of the product corresponding to the randomisation number.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
290

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female aged 40-85 years;
  • Primary knee osteoarthritis complying with the American College or Rheumatology criteria;
  • Radiographically defined osteoarthritis: joint space narrowing and osteophyte in X-ray taken less than one year previously and modified Kellgren-Lawrence grade Ib-III;
  • Symptoms on one side only, with a mean WOMAC A of ≥40 mm. If knee osteoarthritis is bilateral, a difference for that score between the contralateral knee and the selected knee should be of at least 20 mm;
  • Pain present on at least 15 days in the month before inclusion;
  • Failure or intolerance of first line analgesics and NSAIDs;
  • With health insurance;
  • Understanding and following the study instructions;
  • Signed the informed consent.

Exclusion Criteria:

  • Knee osteoarthritis that is not symptomatic or insufficiently symptomatic;
  • Bilateral symptomatic knee osteoarthritis of the same severity on both sides;
  • Post-traumatic secondary knee osteoarthritis;
  • Knee osteoarthritis of radiographic grade I, Ia or IV;
  • Exclusively patellofemoral osteoarthritis where the symptoms are principally of patellofemoral origin (Patellar syndrome);
  • Symptomatic homolateral coxarthrosis;
  • Varus or valgus deformation of the selected knee (deformation axis ≥15° in X-ray);
  • Inflammatory rheumatism (rheumatoid arthritis, psoriatic rheumatism, articular chondrocalcinosis, gout, Paget's disease, ankylosing spondylitis, lupus, etc.);
  • History of injury to the selected knee during the 6 months before inclusion;
  • Venous or lymphatic stenosis of the lower limb;
  • Femoral or sciatic nerve root pain of the lower limb to be tested;
  • Tendinopathy (e.g. hip periarthritis);
  • Treatment with intra-articular hyaluronic acid in the selected knee during the 6 months before inclusion;
  • Intra-articular injection of corticosteroids in the selected knee during the 2 months before inclusion;
  • Treatment with symptomatic slow-acting drugs for osteoarthritis and/or dietary supplements for osteoarthritis (chondroitin sulphate, diacerein, avocado and soybean unsaponifiables, oxaceprol, copper granions, glucosamine) which had been started less than 3 months previously or whose dose had been changed during the last 3 months before inclusion;
  • Total knee replacement of the selected knee;
  • Surgery of the other knee or of the hip or any other surgery scheduled during the period of the study;
  • History of any surgical intervention, arthroscopy, osteotomy, etc. in the year before inclusion;
  • Obesity: body mass index ≥30 kg/m2;
  • History of autoimmune disease;
  • Severe condition likely to interfere with the evaluation, such as neoplasia, malignant blood disease, kidney disease, liver disease or severe infection;
  • Very marked hydrarthrosis (requiring puncture) at the time of inclusion;
  • Wound or skin condition of the selected knee;
  • Anticoagulant treatment with heparin or warfarin (platelet antiaggregants such as ASPIRIN ≤325 mg/d, ticlopidine or clopidogrel were allowed);
  • Known hypersensitivity to hyaluronic acid and/or to avian proteins and/or paracetamol;
  • Known hypersensitivity to mannitol;
  • Participation in a clinical research study within the previous 3 months;
  • Pregnancy, breast-feeding.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: OSTENIL PLUS
A single intra-articular injection of sodium hyaluronate 40 mg/2.0 ml at Day 2, i.e. 2 days post Baseline (Day 0 = Week 0)
Device: OSTENIL PLUS
Injection into the joint cavity of the most painful knee
Active Comparator: SYNVISC-ONE
A single intra-articular injection of hylan G-F 20 48 mg/6 ml at Day 2, i.e. 2 days post Baseline (Day 0 = Week 0)
Device: SYNVISC-ONE
Injection into the joint cavity of the most painful knee

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in WOMAC A
Time Frame: Day 0 to Day 180
Change from baseline in the pain subscore (section A) of the WOMAC score
Day 0 to Day 180

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Lequesne algofunctional index
Time Frame: Day 0 to Day 180
Index assessing the severity of osteoarthritis
Day 0 to Day 180
WOMAC B
Time Frame: Day 0 to Day 180
Stiffness subscore (section B) of the WOMAC score
Day 0 to Day 180
WOMAC C
Time Frame: Day 0 to Day 180
Function subscore (section C) of the WOMAC score
Day 0 to Day 180
Patient's overall status score in relation to his/her knee osteoarthritis
Time Frame: Day 0 to Day 180
Visual analogue scale assessed by the patient
Day 0 to Day 180
Assessment of overall treatment efficacy by the patient
Time Frame: Day 30 to Day 180
5-point scale (1 = very good; 2 = good; 3 = moderate; 4 = poor; 5 = very poor)
Day 30 to Day 180
Assessment of overall treatment efficacy by the investigator
Time Frame: Day 30 to Day 180
5-point scale (1 = very good; 2 = good; 3 = moderate; 4 = poor; 5 = very poor)
Day 30 to Day 180

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of all adverse events
Time Frame: Day 0 to Day 180
Recording of all adverse events and changes in concomitant treatments
Day 0 to Day 180
Incidence of local adverse reactions
Time Frame: Day 30
Recording of adverse manifestations such as post-injection pain, inflammatory reaction, presence of hydrarthrosis, presence of acute pseudoseptic or septic arthritis
Day 30
Assessment of local treatment tolerability by the patient
Time Frame: Day 30
5-point scale scale (1 = very good, 2 = good, 3= moderate, 4 = poor, 5 = very poor)
Day 30
Assessment of local treatment tolerability by the investigator
Time Frame: Day 30
5-point scale scale (1 = very good, 2 = good, 3= moderate, 4 = poor, 5 = very poor)
Day 30
Assessment of overall treatment tolerability by the investigator
Time Frame: Day 30 to Day 180
5-point scale (1 = very good; 2 = good; 3 = moderate; 4 = poor; 5 = very poor)
Day 30 to Day 180
Assessment of overall treatment tolerability by the patient
Time Frame: Day 30 to Day 180
5-point scale (1 = very good; 2 = good; 3 = moderate; 4 = poor; 5 = very poor)
Day 30 to Day 180

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
TRB Chemedica

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Renée Liliane Dreiser, Dr, APHP Bichat-Claude Bernard, Paris, France
  • Study Chair: Bernard Avouac, Dr, APHP Henri Mondor, Creteil, France
  • Principal Investigator: Thomas Bardin, Prof., APHP Lariboisière, Paris, France

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 21, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 22, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 22, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 22, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 29, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 11, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OSTP-EUR-10-01
  • 2011-A00258-33 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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