<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/NCT02967744</url>
  </required_header>
  <id_info>
    <org_study_id>N-20140077</org_study_id>
    <nct_id>NCT02967744</nct_id>
  </id_info>
  <brief_title>NSAID Treatment of Patients With Osteoarthritis</brief_title>
  <official_title>BEVAR: Patientspecifik Behandling Ved Artrose - Et &quot;Proof-of-concept&quot;- Kvalitetssikringsstudie</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aalborg University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aalborg University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study investigates associations between pre treatment pain intensity and central pain&#xD;
      mechanisms on the effect of 8-week treatment of NSAIDs in patients with knee osteoarthritis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2016</start_date>
  <completion_date type="Actual">February 1, 2018</completion_date>
  <primary_completion_date type="Actual">January 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain intensity measured on a 10cm visual analog scale</measure>
    <time_frame>8 weeks after treatment</time_frame>
    <description>Patients will be asked to rate the pain intensity 8 weeks after treatment on a 10cm visual analog scale (0 indicating no pain, 10 indicating worst imaginable pain</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">162</enrollment>
  <condition>Osteoarthritis,Knee</condition>
  <arm_group>
    <arm_group_label>NSAID treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>8 weeks of NSAID treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NSAID</intervention_name>
    <description>NSAIDs are among the most common pain treatments for patients with osteoarthritis.</description>
    <arm_group_label>NSAID treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed Knee Ostoarthritis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current ulcer diagnosed by endoscope&#xD;
&#xD;
          -  Asthma or other allergic reaction to NSIADs&#xD;
&#xD;
          -  Kidney disease&#xD;
&#xD;
          -  Myocardial infarction within the last six months&#xD;
&#xD;
          -  Severe hyper tension (systolic ≥180mmHg, diastolic ≥110mmHg)&#xD;
&#xD;
          -  Severe thrombocytopenia (thrombocyst count &lt;50x10^9/l)&#xD;
&#xD;
          -  Insufficience lever or kidney function&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Center for Sensory Motor Interaction, Aalborg University</name>
      <address>
        <city>Aalborg East</city>
        <zip>9220</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>November 14, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>March 26, 2018</last_update_submitted>
  <last_update_submitted_qc>March 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aalborg University</investigator_affiliation>
    <investigator_full_name>Kristian Kjær Petersen</investigator_full_name>
    <investigator_title>assistant professor</investigator_title>
  </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>
  <!-- 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/NCT02967744
org study id: N-20140077
nct id: NCT02967744
lead sponsor: 
has dmc: No
The study investigates associations between pre treatment pain intensity and central pain
      mechanisms on the effect of 8-week treatment of NSAIDs in patients with knee osteoarthritis.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Pain intensity measured on a 10cm visual analog scale
time frame: 8 weeks after treatment
description: Patients will be asked to rate the pain intensity 8 weeks after treatment on a 10cm visual analog scale (0 indicating no pain, 10 indicating worst imaginable pain
arm group label: NSAID treatment
arm group type: Experimental
description: 8 weeks of NSAID treatment
intervention type: Drug
intervention name: NSAID
description: NSAIDs are among the most common pain treatments for patients with osteoarthritis.
arm group label: NSAID treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Aalborg University
investigator full name: Kristian Kjær Petersen
investigator title: assistant professor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee