<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/NCT02241512</url>
  </required_header>
  <id_info>
    <org_study_id>STU 082014-033</org_study_id>
    <nct_id>NCT02241512</nct_id>
  </id_info>
  <brief_title>IV Ibuprofen for the Prevention of Post-ERCP Pancreatitis</brief_title>
  <official_title>IV Ibuprofen for the Prevention of Post-ERCP Pancreatitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Texas Southwestern Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Texas Southwestern Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Endoscopic retrograde cholangiopancreatography (ERCP) is an advanced endoscopic technique&#xD;
      utilized to diagnose and treat pathologic conditions involving the ducts draining the liver&#xD;
      and pancreas. Post-ERCP pancreatitis (PEP) is the most common complication following ERCP and&#xD;
      occurs in approximately 11% of children undergoing the procedure. By definition it leads to&#xD;
      prolongation of hospital stay or delays in care and rarely can result in long-term morbidity&#xD;
      or even death. Recent adult trials have demonstrated prevention of PEP with administration of&#xD;
      rectal nonsteroidal anti-inflammatory drugs (NSAIDS). To date, no studies have been performed&#xD;
      in children thus no &quot;gold standard&quot; or even commonly accepted method of preventing PEP in the&#xD;
      pediatric population exist. Studying an IV NSAID such as ibuprofen has distinct advantages&#xD;
      over rectally administered NSAIDs in the pediatric population in that it would allow for more&#xD;
      consistent weight based dosing and would have more predictable absorption compared to&#xD;
      suppository. Thus, this project proposes a pilot study evaluating the effectiveness of IV&#xD;
      ibuprofen at preventing PEP in the pediatric population. The design of the proposed study is&#xD;
      a prospective randomized double-blind trial comparing IV Ibuprofen to placebo controls&#xD;
      (normal saline) at the time of procedure in patients undergoing ERCP at Children's Medical&#xD;
      Center Dallas over a two-year period. The primary outcome measurement will be development of&#xD;
      PEP. Post-ERCP bleeding and change in pre- and post- procedural pain scores will also be&#xD;
      measured. The hypothesis is that IV Ibuprofen administered at the time of ERCP will decrease&#xD;
      rates of post-ERCP pancreatitis in pediatric patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    lack of funding&#xD;
  </why_stopped>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">September 2018</completion_date>
  <primary_completion_date type="Actual">September 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>Prevention</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Post-ERCP Pancreatitis</measure>
    <time_frame>2 weeks</time_frame>
    <description>Number of patients who develop post-ERCP pancreatitis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Post-ERCP Bleeding</measure>
    <time_frame>2 weeks</time_frame>
    <description>Number of patients who develop post-ERCP bleeding</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Increased Pain Score</measure>
    <time_frame>pre-procedural, 24 hours</time_frame>
    <description>Number of patients with increased pain scores after the procedure</description>
  </other_outcome>
  <other_outcome>
    <measure>24-h Post-ERCP Pain Score</measure>
    <time_frame>pre-procedural, 24 hours</time_frame>
    <description>Pain score recorded 24-hrs after the ERCP was performed as recorded on a 10-point Likert pain scale (0= lowest value, no pain, 10=highest value, severe pain)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">69</enrollment>
  <condition>Post-ERCP Acute Pancreatitis</condition>
  <arm_group>
    <arm_group_label>Ibuprofen</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single dose IV Ibuprofen at a dose of 10mg/kg (max: 800mg).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Single dose IV normal saline</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ibuprofen</intervention_name>
    <arm_group_label>Ibuprofen</arm_group_label>
    <other_name>Caldolor</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Normal Saline</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age&lt;=18 years&#xD;
&#xD;
          -  Undergoing ERCP (defined as cannulation of the major or minor papilla) for any&#xD;
             indication&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age&gt;18&#xD;
&#xD;
          -  Pancreatitis within the 72 hours preceding ERCP&#xD;
&#xD;
          -  Allergy or hypersensitivity to Aspirin or NSAID medications&#xD;
&#xD;
          -  Pregnancy or breastfeeding mother&#xD;
&#xD;
          -  Cr &gt;1.4&#xD;
&#xD;
          -  Gastrointestinal hemorrhage in preceding 72 hours&#xD;
&#xD;
          -  Heart disease reliant upon a patient ductus arteriosis&#xD;
&#xD;
          -  History of sickle cell disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David M Troendle, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UT Southwestern Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Medical Center of Dallas</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>September 11, 2014</study_first_submitted>
  <study_first_submitted_qc>September 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <results_first_submitted>February 5, 2020</results_first_submitted>
  <results_first_submitted_qc>February 5, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">February 18, 2020</results_first_posted>
  <last_update_submitted>February 5, 2020</last_update_submitted>
  <last_update_submitted_qc>February 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Texas Southwestern Medical Center</investigator_affiliation>
    <investigator_full_name>David M Troendle</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <keyword>post-ERCP pancreatitis</keyword>
  <keyword>pediatric</keyword>
  <keyword>ibuprofen</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ibuprofen</mesh_term>
  </intervention_browse>
  <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>September 18, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/12/NCT02241512/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>10 patients excluded after enrollment. 5 did not undergo ERCP and thus did not receive a study drug. 3 did not have study drug available in time for procedure. 2 did not meet inclusion criteria.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Ibuprofen</title>
          <description>Single dose IV Ibuprofen at a dose of 10mg/kg (max: 800mg).&#xD;
Ibuprofen</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Single dose IV normal saline&#xD;
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="30"/>
                <participants group_id="P2" count="29"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
                <participants group_id="P2" count="29"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Pump malfunction, drug not delivered</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Ibuprofen</title>
          <description>Single dose IV Ibuprofen at a dose of 10mg/kg (max: 800mg).&#xD;
Ibuprofen</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Single dose IV normal saline&#xD;
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="29"/>
            <count group_id="B2" value="29"/>
            <count group_id="B3" value="58"/>
          </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="29"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="58"/>
                  </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="20"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="41"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</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>Mean Pain Score</title>
          <description>Baseline pain score on 10-point Likert scale</description>
          <units>units on a Likert scale</units>
          <param>Mean</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.9" lower_limit="0" upper_limit="4.5"/>
                    <measurement group_id="B2" value="2.2" lower_limit="0" upper_limit="4.0"/>
                    <measurement group_id="B3" value="2.6" lower_limit="0" upper_limit="4.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Post-ERCP Pancreatitis</title>
        <description>Number of patients who develop post-ERCP pancreatitis</description>
        <time_frame>2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ibuprofen</title>
            <description>Single dose IV Ibuprofen at a dose of 10mg/kg (max: 800mg).&#xD;
Ibuprofen</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Single dose IV normal saline&#xD;
placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Post-ERCP Pancreatitis</title>
          <description>Number of patients who develop post-ERCP pancreatitis</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="29"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Post-ERCP Bleeding</title>
        <description>Number of patients who develop post-ERCP bleeding</description>
        <time_frame>2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ibuprofen</title>
            <description>Single dose IV Ibuprofen at a dose of 10mg/kg (max: 800mg).&#xD;
Ibuprofen</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Single dose IV normal saline&#xD;
placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Post-ERCP Bleeding</title>
          <description>Number of patients who develop post-ERCP bleeding</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="29"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Increased Pain Score</title>
        <description>Number of patients with increased pain scores after the procedure</description>
        <time_frame>pre-procedural, 24 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ibuprofen</title>
            <description>Single dose IV Ibuprofen at a dose of 10mg/kg (max: 800mg).&#xD;
Ibuprofen</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Single dose IV normal saline&#xD;
placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Increased Pain Score</title>
          <description>Number of patients with increased pain scores after the procedure</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="29"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>24-h Post-ERCP Pain Score</title>
        <description>Pain score recorded 24-hrs after the ERCP was performed as recorded on a 10-point Likert pain scale (0= lowest value, no pain, 10=highest value, severe pain)</description>
        <time_frame>pre-procedural, 24 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Ibuprofen</title>
            <description>Single dose IV Ibuprofen at a dose of 10mg/kg (max: 800mg).&#xD;
Ibuprofen</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Single dose IV normal saline&#xD;
placebo</description>
          </group>
        </group_list>
        <measure>
          <title>24-h Post-ERCP Pain Score</title>
          <description>Pain score recorded 24-hrs after the ERCP was performed as recorded on a 10-point Likert pain scale (0= lowest value, no pain, 10=highest value, severe pain)</description>
          <units>score on a Likert pain scale</units>
          <param>Mean</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" lower_limit="0" upper_limit="2"/>
                    <measurement group_id="O2" value="3.1" lower_limit="0" upper_limit="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>2 weeks</time_frame>
      <desc>All adverse events were defined by the American Society of Gastroenterology (ASGE) lexicon for endoscopic adverse events.</desc>
      <group_list>
        <group group_id="E1">
          <title>Ibuprofen</title>
          <description>Single dose IV Ibuprofen at a dose of 10mg/kg (max: 800mg).&#xD;
Ibuprofen</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Single dose IV normal saline&#xD;
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="29"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="29"/>
              </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="29"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <description>Post-ERCP Pancreatitis</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <description>Abdominal pain not related to post-ERCP pancreatitis</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Bleeding</sub_title>
                <description>post-ERCP bleeding</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="29"/>
              </event>
              <event>
                <sub_title>Perforation</sub_title>
                <description>ERCP related perforation</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="29"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholangitis</sub_title>
                <description>Post-ERCP cholangitis</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="29"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>Dr. David Troendle</name_or_title>
      <organization>UT Southwestern</organization>
      <phone>214456-8000</phone>
      <email>david.troendle@utsouthwestern.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/NCT02241512
org study id: STU 082014-033
nct id: NCT02241512
lead sponsor: 
has dmc: Yes
Endoscopic retrograde cholangiopancreatography (ERCP) is an advanced endoscopic technique
      utilized to diagnose and treat pathologic conditions involving the ducts draining the liver
      and pancreas. Post-ERCP pancreatitis (PEP) is the most common complication following ERCP and
      occurs in approximately 11% of children undergoing the procedure. By definition it leads to
      prolongation of hospital stay or delays in care and rarely can result in long-term morbidity
      or even death. Recent adult trials have demonstrated prevention of PEP with administration of
      rectal nonsteroidal anti-inflammatory drugs (NSAIDS). To date, no studies have been performed
      in children thus no "gold standard" or even commonly accepted method of preventing PEP in the
      pediatric population exist. Studying an IV NSAID such as ibuprofen has distinct advantages
      over rectally administered NSAIDs in the pediatric population in that it would allow for more
      consistent weight based dosing and would have more predictable absorption compared to
      suppository. Thus, this project proposes a pilot study evaluating the effectiveness of IV
      ibuprofen at preventing PEP in the pediatric population. The design of the proposed study is
      a prospective randomized double-blind trial comparing IV Ibuprofen to placebo controls
      (normal saline) at the time of procedure in patients undergoing ERCP at Children's Medical
      Center Dallas over a two-year period. The primary outcome measurement will be development of
      PEP. Post-ERCP bleeding and change in pre- and post- procedural pain scores will also be
      measured. The hypothesis is that IV Ibuprofen administered at the time of ERCP will decrease
      rates of post-ERCP pancreatitis in pediatric patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Investigator)
measure: Post-ERCP Pancreatitis
time frame: 2 weeks
description: Number of patients who develop post-ERCP pancreatitis
measure: Post-ERCP Bleeding
time frame: 2 weeks
description: Number of patients who develop post-ERCP bleeding
measure: Increased Pain Score
time frame: pre-procedural, 24 hours
description: Number of patients with increased pain scores after the procedure
measure: 24-h Post-ERCP Pain Score
time frame: pre-procedural, 24 hours
description: Pain score recorded 24-hrs after the ERCP was performed as recorded on a 10-point Likert pain scale (0= lowest value, no pain, 10=highest value, severe pain)
arm group label: Ibuprofen
arm group type: Experimental
description: Single dose IV Ibuprofen at a dose of 10mg/kg (max: 800mg).
arm group label: Placebo
arm group type: Placebo Comparator
description: Single dose IV normal saline
intervention type: Drug
intervention name: Ibuprofen
arm group label: Ibuprofen
other name: Caldolor
intervention type: Drug
intervention name: placebo
arm group label: Placebo
other name: Normal Saline
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
healthy volunteers: No
last name: David M Troendle, MD
role: Principal Investigator
affiliation: UT Southwestern Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Texas Southwestern Medical Center
investigator full name: David M Troendle
investigator title: Dr.
mesh term: Pancreatitis
mesh term: Ibuprofen
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 