<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/NCT02195557</url>
  </required_header>
  <id_info>
    <org_study_id>1139.6</org_study_id>
    <nct_id>NCT02195557</nct_id>
  </id_info>
  <brief_title>Retrospective Follow-up Study of Synvisc® in Patients With Knee Osteoarthritis</brief_title>
  <official_title>Synvisc® in Knee Osteoarthritis: Retrospective Follow-up in Treated Patients Since at Least Three Years</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      Retrospective collection of data, aimed at a better knowledge of the use of Synvisc® among&#xD;
      the patients with knee osteoarthritis (OA) since at least three years.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2002</start_date>
  <primary_completion_date type="Actual">March 2003</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Reason for prescription</measure>
    <time_frame>at least 3 years before start of observation period</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of other treatments per patient</measure>
    <time_frame>at least 3 years of observation</time_frame>
    <description>antalgics, non-steroid anti-inflammatory drugs (NSAIDs), steroid anti-inflammatory drugs (SAIDs), specific symptomatic treatments and surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time between two treatments</measure>
    <time_frame>at least 3 years of observation</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">16</enrollment>
  <condition>Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Synvisc®</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Synvisc®</intervention_name>
    <arm_group_label>Synvisc®</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        rheumatological practice&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with knee osteoarthritis using Synvisc® since at least three years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</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 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 21, 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/NCT02195557
org study id: 1139.6
nct id: NCT02195557
lead sponsor: 
Retrospective collection of data, aimed at a better knowledge of the use of Synvisc® among
      the patients with knee osteoarthritis (OA) since at least three years.
observational model: Cohort
time perspective: Prospective
measure: Reason for prescription
time frame: at least 3 years before start of observation period
measure: Number of other treatments per patient
time frame: at least 3 years of observation
description: antalgics, non-steroid anti-inflammatory drugs (NSAIDs), steroid anti-inflammatory drugs (SAIDs), specific symptomatic treatments and surgery
measure: Time between two treatments
time frame: at least 3 years of observation
arm group label: Synvisc®
intervention type: Drug
intervention name: Synvisc®
arm group label: Synvisc®
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
mesh term: Hylan