<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/NCT02187549</url>
  </required_header>
  <id_info>
    <org_study_id>EQE7-13-01</org_study_id>
    <nct_id>NCT02187549</nct_id>
  </id_info>
  <brief_title>Safety and Effectiveness Study of a Non-Crosslinked HA Alkylamide HYADD(TM) 4 Hydrogel for Osteoarthritis of the Knee</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fidia Farmaceutici s.p.a.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fidia Farmaceutici s.p.a.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether intra-articular hyaluronic acid provides&#xD;
      symptomatic relief of osteoarthritis of the knee.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>June 2014</start_date>
  <completion_date type="Anticipated">March 2016</completion_date>
  <primary_completion_date type="Anticipated">February 2016</primary_completion_date>
  <phase>N/A</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain Sub-score</measure>
    <time_frame>26 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Global Assessment</measure>
    <time_frame>26 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">332</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>HYMOVIS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HYADD(TM) 4 Hydrogel Intra-Articular Injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Saline Intra-Articular Injection</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>HYMOVIS</intervention_name>
    <description>Intra-articular injection</description>
    <arm_group_label>HYMOVIS</arm_group_label>
    <other_name>HYADD(TM) 4 Hydrogel Intra-Articular Injection</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Intra-Articular Injection</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Placebo Intra-Articular Injection</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Symptomatic osteoarthritis of the knee.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No disorders which could interfere with study required assessments.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Achieve Clinical Research</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alabama Clinical Therapeutics</name>
      <address>
        <city>Brimingham</city>
        <state>Alabama</state>
        <zip>35235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elite Clinical Studies</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85018</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arizona Research Center</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85023</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Med Center</name>
      <address>
        <city>Carmichael</city>
        <state>California</state>
        <zip>95608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Triwest Research Associates</name>
      <address>
        <city>El Cajon</city>
        <state>California</state>
        <zip>92020</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Westlake Medical</name>
      <address>
        <city>Thousand Oaks</city>
        <state>California</state>
        <zip>91360</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Colorado Orthopedic Consultants</name>
      <address>
        <city>Englewood</city>
        <state>Colorado</state>
        <zip>80110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chase Medical</name>
      <address>
        <city>Waterbury</city>
        <state>Connecticut</state>
        <zip>06708</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Riverside Clinical Research</name>
      <address>
        <city>Edgewater</city>
        <state>Florida</state>
        <zip>32132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Suncoast Clinical Research</name>
      <address>
        <city>New Port Richey</city>
        <state>Florida</state>
        <zip>34652</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ormond Medical Arts</name>
      <address>
        <city>Ormond Beach</city>
        <state>Florida</state>
        <zip>32174</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tufts Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Great Lakes Research Group</name>
      <address>
        <city>Bay City</city>
        <state>Michigan</state>
        <zip>48706</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Healthcare Research Network</name>
      <address>
        <city>Hazelwood</city>
        <state>Missouri</state>
        <zip>63042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fabio Orozco</name>
      <address>
        <city>Egg Harbor Township</city>
        <state>New Jersey</state>
        <zip>08234</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PMG Research of Raleigh</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Horizons</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbus Clinical Research</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Blair Orphopedics</name>
      <address>
        <city>Altoona</city>
        <state>Pennsylvania</state>
        <zip>16602</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Houston Clinical Research</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77055</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>June 29, 2014</study_first_submitted>
  <study_first_submitted_qc>July 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 11, 2014</study_first_posted>
  <last_update_submitted>October 2, 2015</last_update_submitted>
  <last_update_submitted_qc>October 2, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 5, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hyaluronic Acid</keyword>
  <keyword>Osteoarthritis</keyword>
  <keyword>Knee</keyword>
  <keyword>Hyaluronan</keyword>
  <keyword>Viscoelastic</keyword>
  <keyword>Hydrogel</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
  </condition_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/NCT02187549
org study id: EQE7-13-01
nct id: NCT02187549
lead sponsor: 
has dmc: No
The purpose of this study is to determine whether intra-articular hyaluronic acid provides
      symptomatic relief of osteoarthritis of the knee.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain Sub-score
time frame: 26 weeks
measure: Patient Global Assessment
time frame: 26 weeks
arm group label: HYMOVIS
arm group type: Experimental
description: HYADD(TM) 4 Hydrogel Intra-Articular Injection
arm group label: Placebo
arm group type: Placebo Comparator
description: Saline Intra-Articular Injection
intervention type: Device
intervention name: HYMOVIS
description: Intra-articular injection
arm group label: HYMOVIS
other name: HYADD(TM) 4 Hydrogel Intra-Articular Injection
intervention type: Device
intervention name: Placebo
description: Intra-Articular Injection
arm group label: Placebo
other name: Placebo Intra-Articular Injection
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
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country: United States
responsible party type: Sponsor
mesh term: Osteoarthritis