<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/NCT03305848</url>
  </required_header>
  <id_info>
    <org_study_id>A17-134</org_study_id>
    <nct_id>NCT03305848</nct_id>
  </id_info>
  <brief_title>Esophageal Food Impaction</brief_title>
  <acronym>ONEFIT</acronym>
  <official_title>Efficacy and Safety of Oral Nitroglycerin on Esophageal Food Impaction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>HealthPartners Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>HealthPartners Institute</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>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed to obtain data on the safety and efficacy of oral nitroglycerin&#xD;
      solution for the treatment of esophageal food impaction in patients presenting to the&#xD;
      Emergency Department with presumed esophageal food impaction. The main hypothesis is to&#xD;
      determine the success rate of oral nitroglycerin solution in relieving the food impaction by&#xD;
      assessing the resolution of symptoms and the ability of the patient to swallow.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A piece of food stuck in the esophagus (the tube connecting the mouth to the stomach) is a&#xD;
      relatively common occurrence, estimated at a rate of 13 episodes per 100,000 people per year,&#xD;
      mostly men, and usually attributed to swallowed meat. The current standard of care for&#xD;
      patients presenting to an Emergency Department with this problem includes a trial of&#xD;
      medication, usually glucagon but sometimes a carbonated beverage, an injection of&#xD;
      nitroglycerin, or benzodiazepines. The medical interventions mentioned above have not been&#xD;
      shown to be significantly effective and have unwanted side effects; glucagon is known to&#xD;
      cause nausea and vomiting and benzodiazepines can cause sedation and depressed breathing. If&#xD;
      the medication fails to relieve the problem, the patient may require a procedure called&#xD;
      endoscopy, where a video scope and retrieval tool are inserted into the esophagus to remove&#xD;
      the piece of food. There is significant risk associated with endoscopy, including the risks&#xD;
      of anesthesia as well as with the physical procedure itself. Endoscopy also results in a&#xD;
      prolonged hospital stay due to the time required for the procedure, as well as from&#xD;
      anesthesia recovery. The ideal treatment would be a safe, inexpensive, quickly effective&#xD;
      medication without significant side effects that could be administered without sedation or&#xD;
      extensive monitoring. Oral nitroglycerin solution might just be that intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 25, 2017</start_date>
  <completion_date type="Actual">April 4, 2019</completion_date>
  <primary_completion_date type="Actual">April 4, 2019</primary_completion_date>
  <phase>Phase 4</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>Patients Condition at Discharge</measure>
    <time_frame>Length of Emergency Department stay (Time Frame: up to 12 hours)]</time_frame>
    <description>the proportion of study patients who achieve resolution of food impaction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Medications/Procedures Performed During Visit</measure>
    <time_frame>Length of Emergency Department stay (Time Frame: up to 12 hours)]</time_frame>
    <description>Total number of other medications or procedures used to relieve the esophageal food impaction</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Esophageal Food Bolus Obstruction</condition>
  <arm_group>
    <arm_group_label>Oral nitroglycerin solution</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Up to 3 administrations of 0.4mg sublingual nitroglycerin tablets, dissolved in 10mL tap water, given orally in a single swallow. Each administration is separated by at least 5 minutes</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nitrostat 0.4Mg Sublingual Tablet</intervention_name>
    <description>Up to 3 administrations of 0.4mg sublingual nitroglycerin tablets, dissolved in 10mL tap water, given orally in a single swallow. Each administration is separated by at least 5 minutes, and only if systolic blood pressure &gt; 100 mmHg.</description>
    <arm_group_label>Oral nitroglycerin solution</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Over the age of 18 years&#xD;
&#xD;
          -  Presentation consistent with esophageal food impaction&#xD;
&#xD;
          -  Ability to swallow a small volume of liquid.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Intractable vomiting&#xD;
&#xD;
          -  Hemodynamic instability or SBP &lt;100 mmHg&#xD;
&#xD;
          -  Concern for or evidence of significant airway compromise&#xD;
&#xD;
          -  Concern for or evidence of esophageal perforation,&#xD;
&#xD;
          -  Concern for or evidence of coronary ischemia&#xD;
&#xD;
          -  Presentation &gt; 12 hours since onset.&#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>Sam Stellpflug, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Regions Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Regions Hospital</name>
      <address>
        <city>Saint Paul</city>
        <state>Minnesota</state>
        <zip>55101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>October 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 10, 2017</study_first_posted>
  <results_first_submitted>January 11, 2023</results_first_submitted>
  <results_first_submitted_qc>January 11, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">February 8, 2023</results_first_posted>
  <disposition_first_submitted>May 5, 2020</disposition_first_submitted>
  <disposition_first_submitted_qc>May 5, 2020</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">May 8, 2020</disposition_first_posted>
  <last_update_submitted>January 11, 2023</last_update_submitted>
  <last_update_submitted_qc>January 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nitroglycerin</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 26, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/48/NCT03305848/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>20 patients were enrolled who met inclusion for the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Oral Nitroglycerin Solution</title>
          <description>Up to 3 administrations of 0.4mg sublingual nitroglycerin tablets, dissolved in 10mL tap water, given orally in a single swallow. Each administration is separated by at least 5 minutes&#xD;
Nitrostat 0.4Mg Sublingual Tablet: Up to 3 administrations of 0.4mg sublingual nitroglycerin tablets, dissolved in 10mL tap water, given orally in a single swallow. Each administration is separated by at least 5 minutes, and only if systolic blood pressure &gt; 100 mmHg.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Symptom resolution after consent, but before study drug administration</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>17 of the 20 subjects received the study intervention.</population>
      <group_list>
        <group group_id="B1">
          <title>Oral Nitroglycerin Solution</title>
          <description>Up to 3 administrations of 0.4mg sublingual nitroglycerin tablets, dissolved in 10mL tap water, given orally in a single swallow. Each administration is separated by at least 5 minutes&#xD;
Nitrostat 0.4Mg Sublingual Tablet: Up to 3 administrations of 0.4mg sublingual nitroglycerin tablets, dissolved in 10mL tap water, given orally in a single swallow. Each administration is separated by at least 5 minutes, and only if systolic blood pressure &gt; 100 mmHg.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="20"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="47" spread="19.08230098"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Patients Condition at Discharge</title>
        <description>the proportion of study patients who achieve resolution of food impaction</description>
        <time_frame>Length of Emergency Department stay (Time Frame: up to 12 hours)]</time_frame>
        <population>17 of 20 enrolled subjects received the intervention</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Nitroglycerin Solution</title>
            <description>Up to 3 administrations of 0.4mg sublingual nitroglycerin tablets, dissolved in 10mL tap water, given orally in a single swallow. Each administration is separated by at least 5 minutes&#xD;
Nitrostat 0.4Mg Sublingual Tablet: Up to 3 administrations of 0.4mg sublingual nitroglycerin tablets, dissolved in 10mL tap water, given orally in a single swallow. Each administration is separated by at least 5 minutes, and only if systolic blood pressure &gt; 100 mmHg.</description>
          </group>
        </group_list>
        <measure>
          <title>Patients Condition at Discharge</title>
          <description>the proportion of study patients who achieve resolution of food impaction</description>
          <population>17 of 20 enrolled subjects received the intervention</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Resolution with study treatment</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Failure of resolution with study treatment</title>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Medications/Procedures Performed During Visit</title>
        <description>Total number of other medications or procedures used to relieve the esophageal food impaction</description>
        <time_frame>Length of Emergency Department stay (Time Frame: up to 12 hours)]</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Oral Nitroglycerin Solution</title>
            <description>Up to 3 administrations of 0.4mg sublingual nitroglycerin tablets, dissolved in 10mL tap water, given orally in a single swallow. Each administration is separated by at least 5 minutes&#xD;
Nitrostat 0.4Mg Sublingual Tablet: Up to 3 administrations of 0.4mg sublingual nitroglycerin tablets, dissolved in 10mL tap water, given orally in a single swallow. Each administration is separated by at least 5 minutes, and only if systolic blood pressure &gt; 100 mmHg.</description>
          </group>
        </group_list>
        <measure>
          <title>Medications/Procedures Performed During Visit</title>
          <description>Total number of other medications or procedures used to relieve the esophageal food impaction</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="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Received additional medication</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Underwent endoscopy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>7 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Oral Nitroglycerin Solution</title>
          <description>Up to 3 administrations of 0.4mg sublingual nitroglycerin tablets, dissolved in 10mL tap water, given orally in a single swallow. Each administration is separated by at least 5 minutes&#xD;
Nitrostat 0.4Mg Sublingual Tablet: Up to 3 administrations of 0.4mg sublingual nitroglycerin tablets, dissolved in 10mL tap water, given orally in a single swallow. Each administration is separated by at least 5 minutes, and only if systolic blood pressure &gt; 100 mmHg.</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="17"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="17"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <description>SBP &lt; 90</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="17"/>
              </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>Benjamin A Willenbring, MD</name_or_title>
      <organization>Regions Hospital</organization>
      <phone>651-254-3563</phone>
      <email>benjamin.a.willenbring@healthpartners.com</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/NCT03305848
org study id: A17-134
nct id: NCT03305848
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This study is designed to obtain data on the safety and efficacy of oral nitroglycerin
      solution for the treatment of esophageal food impaction in patients presenting to the
      Emergency Department with presumed esophageal food impaction. The main hypothesis is to
      determine the success rate of oral nitroglycerin solution in relieving the food impaction by
      assessing the resolution of symptoms and the ability of the patient to swallow.
A piece of food stuck in the esophagus (the tube connecting the mouth to the stomach) is a
      relatively common occurrence, estimated at a rate of 13 episodes per 100,000 people per year,
      mostly men, and usually attributed to swallowed meat. The current standard of care for
      patients presenting to an Emergency Department with this problem includes a trial of
      medication, usually glucagon but sometimes a carbonated beverage, an injection of
      nitroglycerin, or benzodiazepines. The medical interventions mentioned above have not been
      shown to be significantly effective and have unwanted side effects; glucagon is known to
      cause nausea and vomiting and benzodiazepines can cause sedation and depressed breathing. If
      the medication fails to relieve the problem, the patient may require a procedure called
      endoscopy, where a video scope and retrieval tool are inserted into the esophagus to remove
      the piece of food. There is significant risk associated with endoscopy, including the risks
      of anesthesia as well as with the physical procedure itself. Endoscopy also results in a
      prolonged hospital stay due to the time required for the procedure, as well as from
      anesthesia recovery. The ideal treatment would be a safe, inexpensive, quickly effective
      medication without significant side effects that could be administered without sedation or
      extensive monitoring. Oral nitroglycerin solution might just be that intervention.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Patients Condition at Discharge
time frame: Length of Emergency Department stay (Time Frame: up to 12 hours)]
description: the proportion of study patients who achieve resolution of food impaction
measure: Medications/Procedures Performed During Visit
time frame: Length of Emergency Department stay (Time Frame: up to 12 hours)]
description: Total number of other medications or procedures used to relieve the esophageal food impaction
arm group label: Oral nitroglycerin solution
arm group type: Other
description: Up to 3 administrations of 0.4mg sublingual nitroglycerin tablets, dissolved in 10mL tap water, given orally in a single swallow. Each administration is separated by at least 5 minutes
intervention type: Drug
intervention name: Nitrostat 0.4Mg Sublingual Tablet
description: Up to 3 administrations of 0.4mg sublingual nitroglycerin tablets, dissolved in 10mL tap water, given orally in a single swallow. Each administration is separated by at least 5 minutes, and only if systolic blood pressure > 100 mmHg.
arm group label: Oral nitroglycerin solution
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sam Stellpflug, MD
role: Principal Investigator
affiliation: Regions Hospital
facility: 
country: United States
responsible party type: Sponsor
mesh term: Nitroglycerin
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 