<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/NCT02252926</url>
  </required_header>
  <id_info>
    <org_study_id>P2HNC01</org_study_id>
    <nct_id>NCT02252926</nct_id>
  </id_info>
  <brief_title>Local Anesthetic Treatment of Oral Pain in Patients With Mucositis</brief_title>
  <official_title>Clinical Trial With Lozenges as Local Anesthetic Treatment for Head/Neck Cancer Patients With Oral Mucositis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hvidovre University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Moberg Pharma, Sweden</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hvidovre University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Oral mucositis is a damage to the mucosa of the oral cavity and pharynx. It is a serious and&#xD;
      painful adverse effect caused by the radio therapy and/or chemo therapy patients with head&#xD;
      and neck cancer receive. The pain caused by oral mucositis can be difficult to treat as the&#xD;
      current treatment with opioids is not sufficient and can cause adverse effects.&#xD;
&#xD;
      Our hypothesis is that treatment with a local anesthetic lozenge with bupivacaine can reduce&#xD;
      the oral pain caused by mucositis compared with the current standard treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <phase>Phase 2</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reduction of oral and pharyngeal pain measured on Visual Analogue Scale (VAS)</measure>
    <time_frame>7 days</time_frame>
    <description>The primary outcome measure is the mean VAS score for the patients in the bupivacaine lozenge group compared with the mean VAS score for the patients in the standard treatment group.&#xD;
The lozenge group measures VAS before and 60 min. after administration of a lozenge for seven days. The standard treatment group measures VAS every second hour for seven days.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of the effect of the lozenge</measure>
    <time_frame>7 days</time_frame>
    <description>Mean value of the pain score (VAS) measured 120 minuts after the administration of a lozenge for the patients receiving the lozenges compared with the mean value of the pain score (VAS) measured every second hour for the patients receiving the standard treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of the bupivacaine lozenge</measure>
    <time_frame>7 days</time_frame>
    <description>The difference in pain score (VAS) between the first score in the morning before the first lozenge of the day and the score 60 minuts after the administration of the lozenge. Pain is scored both in the oral cavity and the pharynx.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety: Peak plasma concentrations of bupivacaine</measure>
    <time_frame>90 minutes</time_frame>
    <description>The first ten patients receiving the bupivacaine lozenge will on day seven (the last day of their treatment period) get blood samples drawn before a lozenge is administrated and at time 30 min, 60 min. and 90 min. after the administration.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Mucositis</condition>
  <arm_group>
    <arm_group_label>Bupivacaine lozenge</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The patients can take up to eight 25 mg bupivacaine lozenges (max. every second hour in the awake hours) a day for seven days. The patients can use concomitant systemic pain treatment (e.g. morphine).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard treatment</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The patients will be treated with the currently used standard pain treatment (lidocaine viscous solution, morphine, paracetamol, NSAID, gabapentin). The anesthetics are being administered at the physician's discretion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine</intervention_name>
    <description>25 mg bupivacaine lozenge</description>
    <arm_group_label>Bupivacaine lozenge</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Standard treatment (lidocaine viscous solution, morphine, paracetamol, NSAID, gabapentin)</intervention_name>
    <description>Standard treatment includes lidocaine viscous solution, morphine, paracetamol, NSAID, gabapentin</description>
    <arm_group_label>Standard treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosed with head/neck cancer and starting radio therapy treatment&#xD;
&#xD;
          -  age between 18 and 80 years (both included)&#xD;
&#xD;
          -  able to talk, read and understand Danish&#xD;
&#xD;
          -  ability to give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  known hypersensitivity towards bupivacaine or other local anesthetics of the amide&#xD;
             type&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  women breastfeeding a child&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Claus A Kristensen, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Oncology, Rigshospitalet, Denmark</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jens Bentzen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Oncology Herlev Hospital, Denmark</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Oncology, Rigshospitalet</name>
      <address>
        <city>Copenhagen</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Oncology, Herlev Hospital, Denmark</name>
      <address>
        <city>Herlev</city>
        <zip>2730</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>September 10, 2014</study_first_submitted>
  <study_first_submitted_qc>September 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 30, 2014</study_first_posted>
  <last_update_submitted>August 15, 2016</last_update_submitted>
  <last_update_submitted_qc>August 15, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 16, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rigshospitalet, Denmark</investigator_affiliation>
    <investigator_full_name>Claus Andrup Kristensen</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>Anesthetics, Local</keyword>
  <keyword>Bupivacaine</keyword>
  <keyword>Lozenge</keyword>
  <keyword>Administration, Topical</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mucositis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acetaminophen</mesh_term>
    <mesh_term>Lidocaine</mesh_term>
    <mesh_term>Morphine</mesh_term>
    <mesh_term>Gabapentin</mesh_term>
    <mesh_term>Bupivacaine</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/NCT02252926
org study id: P2HNC01
nct id: NCT02252926
lead sponsor: 
collaborator: 
has dmc: Yes
Oral mucositis is a damage to the mucosa of the oral cavity and pharynx. It is a serious and
      painful adverse effect caused by the radio therapy and/or chemo therapy patients with head
      and neck cancer receive. The pain caused by oral mucositis can be difficult to treat as the
      current treatment with opioids is not sufficient and can cause adverse effects.

      Our hypothesis is that treatment with a local anesthetic lozenge with bupivacaine can reduce
      the oral pain caused by mucositis compared with the current standard treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Reduction of oral and pharyngeal pain measured on Visual Analogue Scale (VAS)
time frame: 7 days
description: The primary outcome measure is the mean VAS score for the patients in the bupivacaine lozenge group compared with the mean VAS score for the patients in the standard treatment group.
The lozenge group measures VAS before and 60 min. after administration of a lozenge for seven days. The standard treatment group measures VAS every second hour for seven days.
measure: Duration of the effect of the lozenge
time frame: 7 days
description: Mean value of the pain score (VAS) measured 120 minuts after the administration of a lozenge for the patients receiving the lozenges compared with the mean value of the pain score (VAS) measured every second hour for the patients receiving the standard treatment.
measure: Effect of the bupivacaine lozenge
time frame: 7 days
description: The difference in pain score (VAS) between the first score in the morning before the first lozenge of the day and the score 60 minuts after the administration of the lozenge. Pain is scored both in the oral cavity and the pharynx.
measure: Safety: Peak plasma concentrations of bupivacaine
time frame: 90 minutes
description: The first ten patients receiving the bupivacaine lozenge will on day seven (the last day of their treatment period) get blood samples drawn before a lozenge is administrated and at time 30 min, 60 min. and 90 min. after the administration.
arm group label: Bupivacaine lozenge
arm group type: Active Comparator
description: The patients can take up to eight 25 mg bupivacaine lozenges (max. every second hour in the awake hours) a day for seven days. The patients can use concomitant systemic pain treatment (e.g. morphine).
arm group label: Standard treatment
arm group type: Other
description: The patients will be treated with the currently used standard pain treatment (lidocaine viscous solution, morphine, paracetamol, NSAID, gabapentin). The anesthetics are being administered at the physician's discretion.
intervention type: Drug
intervention name: Bupivacaine
description: 25 mg bupivacaine lozenge
arm group label: Bupivacaine lozenge
intervention type: Drug
intervention name: Standard treatment (lidocaine viscous solution, morphine, paracetamol, NSAID, gabapentin)
description: Standard treatment includes lidocaine viscous solution, morphine, paracetamol, NSAID, gabapentin
arm group label: Standard treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Claus A Kristensen, MD, PhD
role: Principal Investigator
affiliation: Department of Oncology, Rigshospitalet, Denmark
last name: Jens Bentzen, MD
role: Principal Investigator
affiliation: Department of Oncology Herlev Hospital, Denmark
facility: 
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Rigshospitalet, Denmark
investigator full name: Claus Andrup Kristensen
investigator title: MD, PhD
mesh term: Mucositis
mesh term: Acetaminophen
mesh term: Lidocaine
mesh term: Morphine
mesh term: Gabapentin
mesh term: Bupivacaine