<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02197026</url>
  </required_header>
  <id_info>
    <org_study_id>1139.4</org_study_id>
    <nct_id>NCT02197026</nct_id>
  </id_info>
  <brief_title>Effectiveness and Safety of Synvisc® Versus Usual Treatments in Patients With Knee Osteoarthritis</brief_title>
  <official_title>A Multicentre, Open-label and Randomized Clinical Trial to Compare in Patient With Knee Osteoarthritis the Medicoeconomic Benefits as Well as Effectiveness and Safety of Synvisc® Versus Usual Treatments.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      Comparison of treatment cost of knee osteoarthritis (OA) in patients treated with Synvisc®&#xD;
      versus usual treatments as well as evaluation of safety and effectiveness of these&#xD;
      treatments.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 1998</start_date>
  <primary_completion_date type="Actual">February 2000</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cost of knee OA treatment including cost of side effect related to OA treatment</measure>
    <time_frame>up to 274 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the curve (AUC) Lequesne index</measure>
    <time_frame>Day 1, 29, 91, 182 and 274</time_frame>
    <description>Index of severity</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of Western Ontario and McMaster Universities (WOMAC) index by patient</measure>
    <time_frame>Day 1, 91, 182 and 274</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's assessment of pain on movement and rest on a visual analogue scale (VAS) through WOMAC question 1 and 3</measure>
    <time_frame>Day 1, 91, 182 and 274</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease activity assessment by patient and investigator on a VAS</measure>
    <time_frame>Day 1, 29, 91, 182 and 274</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute congestive OA flares assessed through a questionnaire</measure>
    <time_frame>Day 1, 29, 91, 182 and 274</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of state of health of the patients with a quality of life questionnaire (SF 12)</measure>
    <time_frame>Day 1, 91, 182, 274</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Final global assessment of efficacy by patient and investigator on a four-point verbal rating scale (VRS)</measure>
    <time_frame>Day 274</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Final global assessment of tolerability by patient and investigator on a four-point VRS</measure>
    <time_frame>Day 274</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence and intensity of adverse events</measure>
    <time_frame>up to day 274</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of withdrawals due to adverse event</measure>
    <time_frame>up to day 274</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">518</enrollment>
  <condition>Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Synvisc group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>injection of Synvisc® at day 1, day 8 and day 15; in the mean time it will be recommended to decrease or stop all other OA treatments</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Osteoarthritis standard treatment group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Treatment will be left to the discretion of the investigator who could prescribe any therapies, except viscosupplementation product</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hylan G-F 20</intervention_name>
    <arm_group_label>Synvisc group</arm_group_label>
    <other_name>Synvisc®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Standard treatment</intervention_name>
    <description>Standard drug treatment at the discretion of the investigator</description>
    <arm_group_label>Osteoarthritis standard treatment group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Physiotherapy</intervention_name>
    <arm_group_label>Osteoarthritis standard treatment group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Hydrotherapy</intervention_name>
    <arm_group_label>Osteoarthritis standard treatment group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female outpatient aged at least 18 years&#xD;
&#xD;
          -  Patient suffering from predominant femoro-tibial knee osteoarthrosis with or without&#xD;
             effusion. The diagnosis must be based on American College of Rheumatology (ACR)&#xD;
             criteria. Radiological grade will be assess according to Kellgren-Lawrence scale&#xD;
&#xD;
          -  Assessment of pain on active movement (i.e. walking) (by the patient) must be at least&#xD;
             40 mm on a 100 mm VAS&#xD;
&#xD;
          -  Patient who received at least two courses of at least ten days within the last three&#xD;
             months with non-steroidal antiinflammatory drugs (NSAID) and/or who are treated&#xD;
             continuously for the last two month with slow-acting anti-osteoarthritis drugs&#xD;
&#xD;
          -  Patient's informed written consent obtained in accordance with French legislation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient suffering from acute congestive osteoarthritis flare of the target knee (at&#xD;
             the time of inclusion) which means that concomitantly to knee effusion at least 2 of&#xD;
             the following criteria are present:&#xD;
&#xD;
               -  nocturnal disturbances due to knee pain&#xD;
&#xD;
               -  morning stiffness over 45 minutes&#xD;
&#xD;
               -  increase of knee pain more than 50% within the last week&#xD;
&#xD;
               -  articular reddening&#xD;
&#xD;
               -  articular heat&#xD;
&#xD;
          -  Intra-articular administration of hyaluronic acid in the target knee within the&#xD;
             previous year&#xD;
&#xD;
          -  Intra-articular administration of hyaluronic acid in the target knee within the three&#xD;
             previous months&#xD;
&#xD;
          -  Any other intra-articular injection in the target knee within the last 6 months&#xD;
&#xD;
          -  Any contraindication to intra-articular injections&#xD;
&#xD;
          -  Present or past history of infected target knee joint&#xD;
&#xD;
          -  Previous prosthesis knee surgery, tibial osteotomy, synovectomy or synoviorthese of&#xD;
             the target knee&#xD;
&#xD;
          -  Arthroscopy, articular lavage, debridement, menisectomy of the target knee within the&#xD;
             previous year&#xD;
&#xD;
          -  Planned knee surgery within the nine following month&#xD;
&#xD;
          -  Any other musculoskeletal disorders that can interfere with osteoarthritis diagnosis&#xD;
             or the evaluation of its severity&#xD;
&#xD;
          -  Known hypersensitivity to avian products&#xD;
&#xD;
          -  Presence of lymphatic or venous stasis&#xD;
&#xD;
          -  Pregnancy or breastfeeding&#xD;
&#xD;
          -  Clinical evidence of or known severe cardiac, hepatic, renal, metabolic,&#xD;
             haematological disease, mental disturbance&#xD;
&#xD;
          -  Participation in another clinical trial during this study or during the previous month&#xD;
&#xD;
          -  Previous participation in this trial&#xD;
&#xD;
          -  Patient who requires help concerning shopping or house keeping&#xD;
&#xD;
          -  Patient unable to comply with the protocol (e.g. patient unable to attend each trial&#xD;
             visit or to fill the diary booklet or the quality of life questionnaire)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 18, 2014</study_first_submitted>
  <study_first_submitted_qc>July 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <last_update_submitted>July 21, 2014</last_update_submitted>
  <last_update_submitted_qc>July 21, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 22, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hylan</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02197026
org study id: 1139.4
nct id: NCT02197026
lead sponsor: 
Comparison of treatment cost of knee osteoarthritis (OA) in patients treated with Synvisc®
      versus usual treatments as well as evaluation of safety and effectiveness of these
      treatments.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Cost of knee OA treatment including cost of side effect related to OA treatment
time frame: up to 274 days
measure: Area under the curve (AUC) Lequesne index
time frame: Day 1, 29, 91, 182 and 274
description: Index of severity
measure: Assessment of Western Ontario and McMaster Universities (WOMAC) index by patient
time frame: Day 1, 91, 182 and 274
measure: Patient's assessment of pain on movement and rest on a visual analogue scale (VAS) through WOMAC question 1 and 3
time frame: Day 1, 91, 182 and 274
measure: Disease activity assessment by patient and investigator on a VAS
time frame: Day 1, 29, 91, 182 and 274
measure: Acute congestive OA flares assessed through a questionnaire
time frame: Day 1, 29, 91, 182 and 274
measure: Assessment of state of health of the patients with a quality of life questionnaire (SF 12)
time frame: Day 1, 91, 182, 274
measure: Final global assessment of efficacy by patient and investigator on a four-point verbal rating scale (VRS)
time frame: Day 274
measure: Final global assessment of tolerability by patient and investigator on a four-point VRS
time frame: Day 274
measure: Incidence and intensity of adverse events
time frame: up to day 274
measure: Number of withdrawals due to adverse event
time frame: up to day 274
arm group label: Synvisc group
arm group type: Experimental
description: injection of Synvisc® at day 1, day 8 and day 15; in the mean time it will be recommended to decrease or stop all other OA treatments
arm group label: Osteoarthritis standard treatment group
arm group type: Active Comparator
description: Treatment will be left to the discretion of the investigator who could prescribe any therapies, except viscosupplementation product
intervention type: Drug
intervention name: Hylan G-F 20
arm group label: Synvisc group
other name: Synvisc®
intervention type: Drug
intervention name: Standard treatment
description: Standard drug treatment at the discretion of the investigator
arm group label: Osteoarthritis standard treatment group
intervention type: Procedure
intervention name: Physiotherapy
arm group label: Osteoarthritis standard treatment group
intervention type: Procedure
intervention name: Hydrotherapy
arm group label: Osteoarthritis standard treatment group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
mesh term: Hylan