<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/NCT03241030</url>
  </required_header>
  <id_info>
    <org_study_id>2017-06-0024</org_study_id>
    <nct_id>NCT03241030</nct_id>
  </id_info>
  <brief_title>Sucralfate to Improve Oral Intake in Children With Infectious Oral Ulcers: a Randomized, Double-blind, Placebo-Controlled Trial</brief_title>
  <official_title>Sucralfate to Improve Oral Intake in Children With Infectious Oral Ulcers: a Randomized, Double-blind, Placebo-Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Texas at Austin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Texas at Austin</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to see if sucralfate, a medication commonly used for patients&#xD;
      with stomach ulcers, may help pediatric patients with mouth ulcers decrease their pain level&#xD;
      and improve their ability to drink.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 12, 2017</start_date>
  <completion_date type="Actual">June 20, 2019</completion_date>
  <primary_completion_date type="Actual">July 31, 2018</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Oral Intake in ml/kg</measure>
    <time_frame>Approximately 60 minutes after medication administration.</time_frame>
    <description>Will quantify the amount (in ml/kg) of liquid ingested after intervention.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants That Require Intravenous Fluid Administration</measure>
    <time_frame>6 hours from the time of enrollment</time_frame>
    <description>To explore the difference in the rates of intravenous fluid (IVF) administration in children treated with sucralfate versus placebo.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants That Require Admission</measure>
    <time_frame>6 hours from the time of enrollment</time_frame>
    <description>To explore the difference in the rates admission rates in children treated with sucralfate versus placebo.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Unscheduled Visits</measure>
    <time_frame>Approximately 72 hours from ED visit</time_frame>
    <description>Will call families to find out about any unscheduled visits.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">102</enrollment>
  <condition>Herpangina</condition>
  <condition>Gingivostomatitis</condition>
  <condition>Hand, Foot and Mouth Disease</condition>
  <arm_group>
    <arm_group_label>Experimental Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive sucralfate</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects will receive a placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sucralfate</intervention_name>
    <description>Will receive 20mg/kg/dose up to 1 gram.</description>
    <arm_group_label>Experimental Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Will received placebo solution of similar quantity to that of the weight based dose of sucralfate.</description>
    <arm_group_label>Placebo Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Acetaminophen</intervention_name>
    <description>All patients will receive analgesia, either acetaminophen 15mg/kg or ibuprofen 10mg/kg depending on medication administration prior to arrival in the Emergency Department and at the discretion of the treating physician, in addition to either the experimental drug or placebo.</description>
    <arm_group_label>Experimental Group</arm_group_label>
    <arm_group_label>Placebo Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ibuprofen</intervention_name>
    <description>All patients will receive analgesia, either acetaminophen 15mg/kg or ibuprofen 10mg/kg depending on medication administration prior to arrival in the Emergency Department and at the discretion of the treating physician, in addition to either the experimental drug or placebo.</description>
    <arm_group_label>Experimental Group</arm_group_label>
    <arm_group_label>Placebo Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥6 months and ≤5 years old&#xD;
&#xD;
          -  Present with oral infectious ulcers such as gingivostomatitis, herpangina, or hand,&#xD;
             foot and mouth disease&#xD;
&#xD;
          -  History of decreased oral fluid intake by parent or guardian&#xD;
&#xD;
          -  English or Spanish speaking parents or guardians&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severely dehydrated or toxic, requiring immediate resuscitation&#xD;
&#xD;
          -  Exclusively breastfed&#xD;
&#xD;
          -  Severe dental disease&#xD;
&#xD;
          -  Significant mouth trauma&#xD;
&#xD;
          -  Active Malignancy&#xD;
&#xD;
          -  Preexisting upper airway obstruction or swallowing difficulties&#xD;
&#xD;
          -  Received intravenous fluids within 24 hours&#xD;
&#xD;
          -  Administration of BOTH acetaminophen AND ibuprofen prior to triage and within 4 hours&#xD;
             of enrollment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>5 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nina Vaidya, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UT Dell Medical School</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dell Children's Medical Center</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78723</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>July 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <results_first_submitted>May 17, 2021</results_first_submitted>
  <results_first_submitted_qc>October 26, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">October 29, 2021</results_first_posted>
  <last_update_submitted>October 26, 2021</last_update_submitted>
  <last_update_submitted_qc>October 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Texas at Austin</investigator_affiliation>
    <investigator_full_name>Nidhi Vaidya</investigator_full_name>
    <investigator_title>Resident</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Foot-and-Mouth Disease</mesh_term>
    <mesh_term>Hand, Foot and Mouth Disease</mesh_term>
    <mesh_term>Herpangina</mesh_term>
    <mesh_term>Mouth Diseases</mesh_term>
    <mesh_term>Oral Ulcer</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acetaminophen</mesh_term>
    <mesh_term>Ibuprofen</mesh_term>
    <mesh_term>Sucralfate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 31, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/30/NCT03241030/Prot_SAP_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Experimental Group</title>
          <description>Subjects will receive sucralfate&#xD;
Sucralfate: Will receive 20mg/kg/dose up to 1 gram.&#xD;
Acetaminophen: All patients will receive analgesia, either acetaminophen 15mg/kg or ibuprofen 10mg/kg depending on medication administration prior to arrival in the Emergency Department and at the discretion of the treating physician, in addition to either the experimental drug or placebo.&#xD;
Ibuprofen: All patients will receive analgesia, either acetaminophen 15mg/kg or ibuprofen 10mg/kg depending on medication administration prior to arrival in the Emergency Department and at the discretion of the treating physician, in addition to either the experimental drug or placebo.</description>
        </group>
        <group group_id="P2">
          <title>Placebo Group</title>
          <description>Subjects will receive a placebo&#xD;
Placebo: Will received placebo solution of similar quantity to that of the weight based dose of sucralfate.&#xD;
Acetaminophen: All patients will receive analgesia, either acetaminophen 15mg/kg or ibuprofen 10mg/kg depending on medication administration prior to arrival in the Emergency Department and at the discretion of the treating physician, in addition to either the experimental drug or placebo.&#xD;
Ibuprofen: All patients will receive analgesia, either acetaminophen 15mg/kg or ibuprofen 10mg/kg depending on medication administration prior to arrival in the Emergency Department and at the discretion of the treating physician, in addition to either the experimental drug or placebo.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
                <participants group_id="P2" count="52"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="49"/>
                <participants group_id="P2" count="51"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Experimental Group</title>
          <description>Subjects will receive sucralfate&#xD;
Sucralfate: Will receive 20mg/kg/dose up to 1 gram.&#xD;
Acetaminophen: All patients will receive analgesia, either acetaminophen 15mg/kg or ibuprofen 10mg/kg depending on medication administration prior to arrival in the Emergency Department and at the discretion of the treating physician, in addition to either the experimental drug or placebo.&#xD;
Ibuprofen: All patients will receive analgesia, either acetaminophen 15mg/kg or ibuprofen 10mg/kg depending on medication administration prior to arrival in the Emergency Department and at the discretion of the treating physician, in addition to either the experimental drug or placebo.</description>
        </group>
        <group group_id="B2">
          <title>Placebo Group</title>
          <description>Subjects will receive a placebo&#xD;
Placebo: Will received placebo solution of similar quantity to that of the weight based dose of sucralfate.&#xD;
Acetaminophen: All patients will receive analgesia, either acetaminophen 15mg/kg or ibuprofen 10mg/kg depending on medication administration prior to arrival in the Emergency Department and at the discretion of the treating physician, in addition to either the experimental drug or placebo.&#xD;
Ibuprofen: All patients will receive analgesia, either acetaminophen 15mg/kg or ibuprofen 10mg/kg depending on medication administration prior to arrival in the Emergency Department and at the discretion of the treating physician, in addition to either the experimental drug or placebo.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="49"/>
            <count group_id="B2" value="51"/>
            <count group_id="B3" value="100"/>
          </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="49"/>
                    <measurement group_id="B2" value="51"/>
                    <measurement group_id="B3" value="100"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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="25"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="53"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Hispanic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                    <measurement group_id="B2" value="42"/>
                    <measurement group_id="B3" value="81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>African American/Black</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Oral Intake in ml/kg</title>
        <description>Will quantify the amount (in ml/kg) of liquid ingested after intervention.</description>
        <time_frame>Approximately 60 minutes after medication administration.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Experimental Group</title>
            <description>Subjects will receive sucralfate&#xD;
Sucralfate: Will receive 20mg/kg/dose up to 1 gram.&#xD;
Acetaminophen: All patients will receive analgesia, either acetaminophen 15mg/kg or ibuprofen 10mg/kg depending on medication administration prior to arrival in the Emergency Department and at the discretion of the treating physician, in addition to either the experimental drug or placebo.&#xD;
Ibuprofen: All patients will receive analgesia, either acetaminophen 15mg/kg or ibuprofen 10mg/kg depending on medication administration prior to arrival in the Emergency Department and at the discretion of the treating physician, in addition to either the experimental drug or placebo.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Group</title>
            <description>Subjects will receive a placebo&#xD;
Placebo: Will received placebo solution of similar quantity to that of the weight based dose of sucralfate.&#xD;
Acetaminophen: All patients will receive analgesia, either acetaminophen 15mg/kg or ibuprofen 10mg/kg depending on medication administration prior to arrival in the Emergency Department and at the discretion of the treating physician, in addition to either the experimental drug or placebo.&#xD;
Ibuprofen: All patients will receive analgesia, either acetaminophen 15mg/kg or ibuprofen 10mg/kg depending on medication administration prior to arrival in the Emergency Department and at the discretion of the treating physician, in addition to either the experimental drug or placebo.</description>
          </group>
        </group_list>
        <measure>
          <title>Oral Intake in ml/kg</title>
          <description>Will quantify the amount (in ml/kg) of liquid ingested after intervention.</description>
          <units>oral intake in ml/kg</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.7" lower_limit="3.9" upper_limit="19.4"/>
                    <measurement group_id="O2" value="10.7" lower_limit="7.2" upper_limit="17.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants That Require Intravenous Fluid Administration</title>
        <description>To explore the difference in the rates of intravenous fluid (IVF) administration in children treated with sucralfate versus placebo.</description>
        <time_frame>6 hours from the time of enrollment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Experimental Group</title>
            <description>Subjects will receive sucralfate&#xD;
Sucralfate: Will receive 20mg/kg/dose up to 1 gram.&#xD;
Acetaminophen: All patients will receive analgesia, either acetaminophen 15mg/kg or ibuprofen 10mg/kg depending on medication administration prior to arrival in the Emergency Department and at the discretion of the treating physician, in addition to either the experimental drug or placebo.&#xD;
Ibuprofen: All patients will receive analgesia, either acetaminophen 15mg/kg or ibuprofen 10mg/kg depending on medication administration prior to arrival in the Emergency Department and at the discretion of the treating physician, in addition to either the experimental drug or placebo.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Group</title>
            <description>Subjects will receive a placebo&#xD;
Placebo: Will received placebo solution of similar quantity to that of the weight based dose of sucralfate.&#xD;
Acetaminophen: All patients will receive analgesia, either acetaminophen 15mg/kg or ibuprofen 10mg/kg depending on medication administration prior to arrival in the Emergency Department and at the discretion of the treating physician, in addition to either the experimental drug or placebo.&#xD;
Ibuprofen: All patients will receive analgesia, either acetaminophen 15mg/kg or ibuprofen 10mg/kg depending on medication administration prior to arrival in the Emergency Department and at the discretion of the treating physician, in addition to either the experimental drug or placebo.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants That Require Intravenous Fluid Administration</title>
          <description>To explore the difference in the rates of intravenous fluid (IVF) administration in children treated with sucralfate versus placebo.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants That Require Admission</title>
        <description>To explore the difference in the rates admission rates in children treated with sucralfate versus placebo.</description>
        <time_frame>6 hours from the time of enrollment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Experimental Group</title>
            <description>Subjects will receive sucralfate&#xD;
Sucralfate: Will receive 20mg/kg/dose up to 1 gram.&#xD;
Acetaminophen: All patients will receive analgesia, either acetaminophen 15mg/kg or ibuprofen 10mg/kg depending on medication administration prior to arrival in the Emergency Department and at the discretion of the treating physician, in addition to either the experimental drug or placebo.&#xD;
Ibuprofen: All patients will receive analgesia, either acetaminophen 15mg/kg or ibuprofen 10mg/kg depending on medication administration prior to arrival in the Emergency Department and at the discretion of the treating physician, in addition to either the experimental drug or placebo.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Group</title>
            <description>Subjects will receive a placebo&#xD;
Placebo: Will received placebo solution of similar quantity to that of the weight based dose of sucralfate.&#xD;
Acetaminophen: All patients will receive analgesia, either acetaminophen 15mg/kg or ibuprofen 10mg/kg depending on medication administration prior to arrival in the Emergency Department and at the discretion of the treating physician, in addition to either the experimental drug or placebo.&#xD;
Ibuprofen: All patients will receive analgesia, either acetaminophen 15mg/kg or ibuprofen 10mg/kg depending on medication administration prior to arrival in the Emergency Department and at the discretion of the treating physician, in addition to either the experimental drug or placebo.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants That Require Admission</title>
          <description>To explore the difference in the rates admission rates in children treated with sucralfate versus placebo.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Unscheduled Visits</title>
        <description>Will call families to find out about any unscheduled visits.</description>
        <time_frame>Approximately 72 hours from ED visit</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Experimental Group</title>
            <description>Subjects will receive sucralfate&#xD;
Sucralfate: Will receive 20mg/kg/dose up to 1 gram.&#xD;
Acetaminophen: All patients will receive analgesia, either acetaminophen 15mg/kg or ibuprofen 10mg/kg depending on medication administration prior to arrival in the Emergency Department and at the discretion of the treating physician, in addition to either the experimental drug or placebo.&#xD;
Ibuprofen: All patients will receive analgesia, either acetaminophen 15mg/kg or ibuprofen 10mg/kg depending on medication administration prior to arrival in the Emergency Department and at the discretion of the treating physician, in addition to either the experimental drug or placebo.</description>
          </group>
          <group group_id="O2">
            <title>Placebo Group</title>
            <description>Subjects will receive a placebo&#xD;
Placebo: Will received placebo solution of similar quantity to that of the weight based dose of sucralfate.&#xD;
Acetaminophen: All patients will receive analgesia, either acetaminophen 15mg/kg or ibuprofen 10mg/kg depending on medication administration prior to arrival in the Emergency Department and at the discretion of the treating physician, in addition to either the experimental drug or placebo.&#xD;
Ibuprofen: All patients will receive analgesia, either acetaminophen 15mg/kg or ibuprofen 10mg/kg depending on medication administration prior to arrival in the Emergency Department and at the discretion of the treating physician, in addition to either the experimental drug or placebo.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Unscheduled Visits</title>
          <description>Will call families to find out about any unscheduled visits.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Until discharge from ED (Average time 3.5 hours)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Experimental Group</title>
          <description>Subjects will receive sucralfate&#xD;
Sucralfate: Will receive 20mg/kg/dose up to 1 gram.&#xD;
Acetaminophen: All patients will receive analgesia, either acetaminophen 15mg/kg or ibuprofen 10mg/kg depending on medication administration prior to arrival in the Emergency Department and at the discretion of the treating physician, in addition to either the experimental drug or placebo.&#xD;
Ibuprofen: All patients will receive analgesia, either acetaminophen 15mg/kg or ibuprofen 10mg/kg depending on medication administration prior to arrival in the Emergency Department and at the discretion of the treating physician, in addition to either the experimental drug or placebo.</description>
        </group>
        <group group_id="E2">
          <title>Placebo Group</title>
          <description>Subjects will receive a placebo&#xD;
Placebo: Will received placebo solution of similar quantity to that of the weight based dose of sucralfate.&#xD;
Acetaminophen: All patients will receive analgesia, either acetaminophen 15mg/kg or ibuprofen 10mg/kg depending on medication administration prior to arrival in the Emergency Department and at the discretion of the treating physician, in addition to either the experimental drug or placebo.&#xD;
Ibuprofen: All patients will receive analgesia, either acetaminophen 15mg/kg or ibuprofen 10mg/kg depending on medication administration prior to arrival in the Emergency Department and at the discretion of the treating physician, in addition to either the experimental drug or placebo.</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="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
              </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="49"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="51"/>
              </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>
    <point_of_contact>
      <name_or_title>Nidhi Singh, MD</name_or_title>
      <organization>Baylor College of Medicine</organization>
      <phone>832-824-2771</phone>
      <email>nidhi.singh@bcm.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/NCT03241030
org study id: 2017-06-0024
nct id: NCT03241030
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The purpose of this study is to see if sucralfate, a medication commonly used for patients
      with stomach ulcers, may help pediatric patients with mouth ulcers decrease their pain level
      and improve their ability to drink.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Oral Intake in ml/kg
time frame: Approximately 60 minutes after medication administration.
description: Will quantify the amount (in ml/kg) of liquid ingested after intervention.
measure: Number of Participants That Require Intravenous Fluid Administration
time frame: 6 hours from the time of enrollment
description: To explore the difference in the rates of intravenous fluid (IVF) administration in children treated with sucralfate versus placebo.
measure: Number of Participants That Require Admission
time frame: 6 hours from the time of enrollment
description: To explore the difference in the rates admission rates in children treated with sucralfate versus placebo.
measure: Number of Participants With Unscheduled Visits
time frame: Approximately 72 hours from ED visit
description: Will call families to find out about any unscheduled visits.
arm group label: Experimental Group
arm group type: Experimental
description: Subjects will receive sucralfate
arm group label: Placebo Group
arm group type: Placebo Comparator
description: Subjects will receive a placebo
intervention type: Drug
intervention name: Sucralfate
description: Will receive 20mg/kg/dose up to 1 gram.
arm group label: Experimental Group
intervention type: Other
intervention name: Placebo
description: Will received placebo solution of similar quantity to that of the weight based dose of sucralfate.
arm group label: Placebo Group
intervention type: Drug
intervention name: Acetaminophen
description: All patients will receive analgesia, either acetaminophen 15mg/kg or ibuprofen 10mg/kg depending on medication administration prior to arrival in the Emergency Department and at the discretion of the treating physician, in addition to either the experimental drug or placebo.
arm group label: Experimental Group
arm group label: Placebo Group
intervention type: Drug
intervention name: Ibuprofen
description: All patients will receive analgesia, either acetaminophen 15mg/kg or ibuprofen 10mg/kg depending on medication administration prior to arrival in the Emergency Department and at the discretion of the treating physician, in addition to either the experimental drug or placebo.
arm group label: Experimental Group
arm group label: Placebo Group
criteria: 
gender: All
minimum age: 6 Months
maximum age: 5 Years
healthy volunteers: No
last name: Nina Vaidya, MD
role: Principal Investigator
affiliation: UT Dell Medical School
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Texas at Austin
investigator full name: Nidhi Vaidya
investigator title: Resident
mesh term: Foot-and-Mouth Disease
mesh term: Hand, Foot and Mouth Disease
mesh term: Herpangina
mesh term: Mouth Diseases
mesh term: Oral Ulcer
mesh term: Acetaminophen
mesh term: Ibuprofen
mesh term: Sucralfate
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 