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

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ClinicalTrials.gov Identifier: NCT03203408
Recruitment Status : Completed
First Posted : June 29, 2017
Last Update Posted : October 11, 2017
Sponsor:
Information provided by (Responsible Party):
TRB Chemedica

Tracking Information
First Submitted Date  ICMJE June 22, 2017
First Posted Date  ICMJE June 29, 2017
Last Update Posted Date October 11, 2017
Actual Study Start Date  ICMJE June 21, 2011
Actual Primary Completion Date November 22, 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2017)
Change in WOMAC A [ Time Frame: Day 0 to Day 180 ]
Change from baseline in the pain subscore (section A) of the WOMAC score
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03203408 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2017)
  • Lequesne algofunctional index [ Time Frame: Day 0 to Day 180 ]
    Index assessing the severity of osteoarthritis
  • WOMAC B [ Time Frame: Day 0 to Day 180 ]
    Stiffness subscore (section B) of the WOMAC score
  • WOMAC C [ Time Frame: Day 0 to Day 180 ]
    Function subscore (section C) of the WOMAC score
  • 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
  • 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)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 26, 2017)
  • Incidence of all adverse events [ Time Frame: Day 0 to Day 180 ]
    Recording of all adverse events and changes in concomitant treatments
  • 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
  • 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)
  • 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)
  • 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)
  • 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)
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Efficacy of OSTENIL PLUS (Hyaluronic Acid) Versus SYNVISC-ONE in Patients With Tibiofemoral Osteoarthritis
Official Title  ICMJE 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
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
This study was a multicentre, prospective, double-blind, randomised, controlled non-inferiority study in two parallel groups of patients followed up for six months.
Masking: Double (Participant, Outcomes Assessor)
Masking Description:
To prevent the patients from knowing the nature of their treatment, the investigational products OSTENIL PLUS and SYNVISC-ONE were packed in identical neutral packs. OSTENIL PLUS and SYNVISC-ONE differ in appearance (product volume and viscosity, prefilled syringe) and were therefore readily identifiable by the investigator administering the investigational product (i.e. injecting investigator). The double-blind masking could be ensured thanks to the intervention of an observer who did not know the nature of the treatment, namely the evaluating investigator. The treatment was therefore administered blind to the evaluating investigator and the patient but not to the injecting investigator.
Primary Purpose: Treatment
Condition  ICMJE Knee Osteoarthritis
Intervention  ICMJE
  • Device: OSTENIL PLUS
    Injection into the joint cavity of the most painful knee
  • Device: SYNVISC-ONE
    Injection into the joint cavity of the most painful knee
Study Arms  ICMJE
  • 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)
    Intervention: Device: OSTENIL PLUS
  • 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)
    Intervention: Device: SYNVISC-ONE
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 26, 2017)
290
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 22, 2012
Actual Primary Completion Date November 22, 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03203408
Other Study ID Numbers  ICMJE OSTP-EUR-10-01
2011-A00258-33 ( Other Identifier: ID-RCB )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party TRB Chemedica
Study Sponsor  ICMJE TRB Chemedica
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account TRB Chemedica
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP