<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/NCT02241486</url>
  </required_header>
  <id_info>
    <org_study_id>205025</org_study_id>
    <nct_id>NCT02241486</nct_id>
  </id_info>
  <brief_title>Sublingual Fentanyl and Procedural Burn Pain</brief_title>
  <official_title>A Randomized, Double-blind, Placebo-controlled, Cross-over Trial of Sublingual Fentanyl Spray (Subsys) and Oral Morphine for Procedural Wound Care in Adult Patients With Burn Injury Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Loyola University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Loyola University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to examine the efficacy and safety of sublingual fentanyl spray&#xD;
      (Subsys) for procedural pain (dressing changes/minor debridement) in patients with burn&#xD;
      injury.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to examine the efficacy and safety of sublingual fentanyl spray&#xD;
      (Subsys) for procedural pain (dressing changes/minor debridement) in patients with burn&#xD;
      injury. It will be compared with a standard treatment regimen of oral morphine. The&#xD;
      hypothesis is that the fentanyl spray will be more effective for the treatment of procedural&#xD;
      pain in patients with burn injury.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    No funding source.&#xD;
  </why_stopped>
  <start_date>September 2013</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">September 2014</primary_completion_date>
  <phase>Phase 3</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain Relief</measure>
    <time_frame>60 min</time_frame>
    <description>Patients suffering from burn injuries will receive sublingual fentanyl spray (Subsys) to address procedural pain (dressing changes/minor debridement). It will be compared with a standard treatment regimen of oral morphine. The hypothesis is that the fentanyl spray will be more effective for the treatment of procedural pain in patients with burn injury.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Burn Pain</condition>
  <arm_group>
    <arm_group_label>Sublingual Fentanyl Spray</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Examine the efficacy and safety of sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement) in patients with burn injury.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sublingual Fentanyl Spray</intervention_name>
    <description>Patients with burn injuries will receive sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement).</description>
    <arm_group_label>Sublingual Fentanyl Spray</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject capable of giving consent&#xD;
&#xD;
          -  Age 18-65&#xD;
&#xD;
          -  Total burn surface area greater than or equal to 5%&#xD;
&#xD;
          -  Opioid tolerant&#xD;
&#xD;
          -  BMI less than or equal to 35&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with cognitive or psychiatric impairment that would preclude study&#xD;
             participation or compliance with protocol&#xD;
&#xD;
          -  Allergy to fentanyl, morphine, naloxone&#xD;
&#xD;
          -  Pregnancy, intent to become pregnant or lactating&#xD;
&#xD;
          -  Evidence of burn injury to oral mucosa&#xD;
&#xD;
          -  Active illicit drug use or illicit drug abuse history&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joseph R Holtman Jr, MD Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department Anesthesiology Loyola University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Loyola University Medical Center Burn Unit</name>
      <address>
        <city>Maywood</city>
        <state>Illinois</state>
        <zip>60153</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>November 12, 2013</study_first_submitted>
  <study_first_submitted_qc>September 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <results_first_submitted>May 5, 2017</results_first_submitted>
  <results_first_submitted_qc>May 5, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">June 9, 2017</results_first_posted>
  <last_update_submitted>June 30, 2017</last_update_submitted>
  <last_update_submitted_qc>June 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Loyola University</investigator_affiliation>
    <investigator_full_name>Joseph Holtman</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Burn pain</keyword>
  <keyword>Procedural pain</keyword>
  <keyword>Sublingual fentanyl</keyword>
  <keyword>Morphine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Burns</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fentanyl</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>There are no pre-assignment details.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Sublingual Fentanyl Spray</title>
          <description>Examine the efficacy and safety of sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement) in patients with burn injury.&#xD;
Sublingual Fentanyl Spray: Patients with burn injuries will receive sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Only two patients were initially enrolled in this trial, which was terminated prematurely.</population>
      <group_list>
        <group group_id="B1">
          <title>Sublingual Fentanyl Spray</title>
          <description>Examine the efficacy and safety of sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement) in patients with burn injury.&#xD;
Sublingual Fentanyl Spray: Patients with burn injuries will receive sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement).</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="2"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Pain Relief</title>
        <description>Patients suffering from burn injuries will receive sublingual fentanyl spray (Subsys) to address procedural pain (dressing changes/minor debridement). It will be compared with a standard treatment regimen of oral morphine. The hypothesis is that the fentanyl spray will be more effective for the treatment of procedural pain in patients with burn injury.</description>
        <time_frame>60 min</time_frame>
        <population>No participants are included in this analysis because the trial was terminated prematurely. As a result, data to assess primary and secondary study aims are incomplete or entirely unavailable for summary or statistical comparisons.</population>
        <group_list>
          <group group_id="O1">
            <title>Sublingual Fentanyl Spray</title>
            <description>Examine the efficacy and safety of sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement) in patients with burn injury.&#xD;
Sublingual Fentanyl Spray: Patients with burn injuries will receive sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement).</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Relief</title>
          <description>Patients suffering from burn injuries will receive sublingual fentanyl spray (Subsys) to address procedural pain (dressing changes/minor debridement). It will be compared with a standard treatment regimen of oral morphine. The hypothesis is that the fentanyl spray will be more effective for the treatment of procedural pain in patients with burn injury.</description>
          <population>No participants are included in this analysis because the trial was terminated prematurely. As a result, data to assess primary and secondary study aims are incomplete or entirely unavailable for summary or statistical comparisons.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Sublingual Fentanyl Spray</title>
          <description>Examine the efficacy and safety of sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement) in patients with burn injury.&#xD;
Sublingual Fentanyl Spray: Patients with burn injuries will receive sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement).</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>This trial was terminated prematurely due to a lack of study funding.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Joseph R. Holtman</name_or_title>
      <organization>Loyola University Medical Center</organization>
      <phone>7082168563</phone>
      <email>jholtman@luc.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02241486
org study id: 205025
nct id: NCT02241486
lead sponsor: 
has dmc: No
The purpose of this study is to examine the efficacy and safety of sublingual fentanyl spray
      (Subsys) for procedural pain (dressing changes/minor debridement) in patients with burn
      injury.
The purpose of this study is to examine the efficacy and safety of sublingual fentanyl spray
      (Subsys) for procedural pain (dressing changes/minor debridement) in patients with burn
      injury. It will be compared with a standard treatment regimen of oral morphine. The
      hypothesis is that the fentanyl spray will be more effective for the treatment of procedural
      pain in patients with burn injury.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pain Relief
time frame: 60 min
description: Patients suffering from burn injuries will receive sublingual fentanyl spray (Subsys) to address procedural pain (dressing changes/minor debridement). It will be compared with a standard treatment regimen of oral morphine. The hypothesis is that the fentanyl spray will be more effective for the treatment of procedural pain in patients with burn injury.
arm group label: Sublingual Fentanyl Spray
arm group type: Experimental
description: Examine the efficacy and safety of sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement) in patients with burn injury.
intervention type: Drug
intervention name: Sublingual Fentanyl Spray
description: Patients with burn injuries will receive sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement).
arm group label: Sublingual Fentanyl Spray
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Joseph R Holtman Jr, MD Ph.D.
role: Principal Investigator
affiliation: Department Anesthesiology Loyola University Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Loyola University
investigator full name: Joseph Holtman
investigator title: Professor
mesh term: Burns
mesh term: Fentanyl
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: This trial was terminated prematurely due to a lack of study funding.
point of contact: 