<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/NCT02247024</url>
  </required_header>
  <id_info>
    <org_study_id>2014/1226</org_study_id>
    <nct_id>NCT02247024</nct_id>
  </id_info>
  <brief_title>Pupil Response in Patients on Opioids.</brief_title>
  <acronym>Pupillometry</acronym>
  <official_title>Dynamic Assessment of Pupillary Reflex in Patients on High-dose Opioids</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oslo University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oslo University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluation of pupillary reflex in patients on high-dose opioids. Clinical assessment of pain&#xD;
      intensity, sedation score, and other side effects of opioids. Measurements of the&#xD;
      concentration of opioids and their active metabolites in blood.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pupil size reflects the balance between sympathetic and parasympathetic systems. Pupil size&#xD;
      and reaction are also influenced by drugs, where opioids result in miosis, an effect that is&#xD;
      not considered to be influenced by opioid tolerance. However, cancer patients on high-dose&#xD;
      opioids do not always present small pupil size.&#xD;
&#xD;
      We want to perform a dynamic assessment of pupillary reflex in patients on high-dose opioids.&#xD;
      In addition to pupil size measurements under standard room light conditions, two pupil size&#xD;
      reflexes will by assessed: the pupillary light reflex when the pupil is exposed to light, and&#xD;
      the reflex dilation during a standardized noxious stimulus. On the same time we will assess&#xD;
      pain intensity, sedation score, and other side effects of opioids while measuring the&#xD;
      concentration of opioids and their active metabolites in blood. In addition we will register&#xD;
      all concomitant medication that also might influence pupil size and reaction. Patients on&#xD;
      more than 60 morphine equivalents pr day will be included.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">November 2018</completion_date>
  <primary_completion_date type="Actual">August 2018</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>Pupillary reflexes</measure>
    <time_frame>One year</time_frame>
    <description>Dynamic pupillometry</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Opioid and metabolite concentration</measure>
    <time_frame>One year</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">63</enrollment>
  <condition>Chronic Pain</condition>
  <condition>Impaired Pupillary Reflex</condition>
  <condition>Opioid-Related Disorders</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Whole blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Cancer pain on high-dose opioids; i.e. more than 60 morphine equivalents pr day&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  In-patients and out-patients at Oslo University Hospital with cancer pain who have use&#xD;
             opioids (morphine, oxycodone, fentanyl or methadone or a combination of these drugs)&#xD;
             at least for periods of 4 weeks, and use opioids corresponding to at least 60 mg oral&#xD;
             morphine equivalents pr day&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have undergone eye-surgery that may influence pupillary reflexes&#xD;
&#xD;
          -  Patients on local medication that may influence pupillary reflexes&#xD;
&#xD;
          -  Patients with amyloidosis, multiple sclerosis, Horner's syndrome, or ongoing migraine&#xD;
             attack&#xD;
&#xD;
          -  Patients with brain tumor&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ulf E Kongsgaard, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oslo University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Oslo University Hospital, The Norwegian Radium Hospital</name>
      <address>
        <city>Oslo</city>
        <zip>0310</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Norwegian Radium Hospital</name>
      <address>
        <city>Oslo</city>
        <zip>0310</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>September 19, 2014</study_first_submitted>
  <study_first_submitted_qc>September 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 23, 2014</study_first_posted>
  <last_update_submitted>January 28, 2019</last_update_submitted>
  <last_update_submitted_qc>January 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oslo University Hospital</investigator_affiliation>
    <investigator_full_name>Ulf Kongsgaard</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Pain</mesh_term>
    <mesh_term>Opioid-Related Disorders</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/NCT02247024
org study id: 2014/1226
nct id: NCT02247024
lead sponsor: 
has dmc: No
Evaluation of pupillary reflex in patients on high-dose opioids. Clinical assessment of pain
      intensity, sedation score, and other side effects of opioids. Measurements of the
      concentration of opioids and their active metabolites in blood.
Pupil size reflects the balance between sympathetic and parasympathetic systems. Pupil size
      and reaction are also influenced by drugs, where opioids result in miosis, an effect that is
      not considered to be influenced by opioid tolerance. However, cancer patients on high-dose
      opioids do not always present small pupil size.

      We want to perform a dynamic assessment of pupillary reflex in patients on high-dose opioids.
      In addition to pupil size measurements under standard room light conditions, two pupil size
      reflexes will by assessed: the pupillary light reflex when the pupil is exposed to light, and
      the reflex dilation during a standardized noxious stimulus. On the same time we will assess
      pain intensity, sedation score, and other side effects of opioids while measuring the
      concentration of opioids and their active metabolites in blood. In addition we will register
      all concomitant medication that also might influence pupil size and reaction. Patients on
      more than 60 morphine equivalents pr day will be included.
observational model: Cohort
time perspective: Prospective
measure: Pupillary reflexes
time frame: One year
description: Dynamic pupillometry
measure: Opioid and metabolite concentration
time frame: One year
Whole blood
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ulf E Kongsgaard, MD PhD
role: Principal Investigator
affiliation: Oslo University Hospital
facility: 
facility: 
country: Norway
responsible party type: Principal Investigator
investigator affiliation: Oslo University Hospital
investigator full name: Ulf Kongsgaard
investigator title: Professor
mesh term: Chronic Pain
mesh term: Opioid-Related Disorders