<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/NCT02235311</url>
  </required_header>
  <id_info>
    <org_study_id>1212917</org_study_id>
    <nct_id>NCT02235311</nct_id>
  </id_info>
  <brief_title>Optimal Dose of Proton Pump Inhibitors Following an Upper Gastrointestinal Bleed</brief_title>
  <official_title>Optimal Dose of Proton Pump Inhibitors Following an Upper Gastrointestinal Bleed</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Missouri-Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Missouri-Columbia</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Despite recommendations from clinical practice guidelines to discharge patients from the&#xD;
      hospital on once daily proton pump inhibitors after acute management of UGIB, clinical&#xD;
      practice is to use twice daily proton pump inhibitor therapy. The objective of this study&#xD;
      will be to assess whether or not once daily pantoprazole is non-inferior to twice daily&#xD;
      pantoprazole in ulcer healing with a dose of once daily versus twice daily proton-pump&#xD;
      inhibitor following an upper gastrointestinal bleed. Additionally, this study will observe&#xD;
      for any potential difference in safety for once daily versus twice daily proton pump&#xD;
      inhibitors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There are few clinical practice guidelines for the management of a non-variceal, upper&#xD;
      gastrointestinal bleed (UGIB). The 2012 guidelines released by the American College of&#xD;
      Gastroenterology (ACG) indicate that for active bleeding or non-bleeding visible vessels or&#xD;
      adherent clot, a bolus of 80 mg proton pump inhibitor followed by continuous infusion of 8&#xD;
      mg/hr infusion is to be used. Following 72 hours of infusion therapy, an oral proton pump&#xD;
      inhibitor (PPI) may be used. If the clot is a flat pigmented spot or a clean ulcer base, an&#xD;
      oral proton pump inhibitor may be used for management (without infusion) (Laine 2012). There&#xD;
      are no recommendations made on once versus twice daily proton pump inhibitor. The 2010&#xD;
      American College of Physicians guideline recommends following the 72-hour infusion with&#xD;
      once-daily proton pump inhibitors for duration as dictated by underlying etiology following&#xD;
      upper gastrointestinal bleeding (UGIB) (Barkun 2012). This recommendation is graded 1C, with&#xD;
      the decision to support once-daily over twice-daily dosing due to demonstrated effective&#xD;
      ulcer healing for patients with peptic ulcer disease with once-daily dosing, and insufficient&#xD;
      data to suggest twice-daily is superior to once-daily. There have been no head-to-head trials&#xD;
      to evaluate once-daily versus twice-daily proton pump inhibitor following acute management of&#xD;
      an endoscopic bleed. Additionally, studies suggest about 50% to 60% of proton pump inhibitors&#xD;
      are being used without appropriate indications or at inappropriate dosages (Ali 2009).Safety&#xD;
      concerns such as increased risk for Clostridium difficile infection , community acquired&#xD;
      pneumonia, electrolyte abnormalities (hypomagnesemia), and fractures are becoming more&#xD;
      prevalent warranting improved risk versus benefit examination of proton pump inhibitors&#xD;
      including ascertainment of least effective dosing (Ali 2009, Sheen 2011). Despite&#xD;
      recommendations to discharge patients after acute management of UGIB on once daily PPI&#xD;
      therapy, clinical practice is to use twice daily proton pump inhibitor therapy. The objective&#xD;
      of this study will be to examine if once daily pantoprazole is non-inferior to twice daily&#xD;
      pantoprazole with regards to ulcer healing after acute management of an UGIB. In addition,&#xD;
      because more evidence is emerging regarding safety concerns with proton pump inhibitors, the&#xD;
      study will seek to examine if once daily versus twice daily therapy results in difference in&#xD;
      safety or adverse reactions such as occurrence of rebleed, C. difficile diarrhea, or&#xD;
      pneumonia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Difficulty recruiting and consenting participants&#xD;
  </why_stopped>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">August 17, 2015</completion_date>
  <primary_completion_date type="Actual">August 17, 2015</primary_completion_date>
  <phase>N/A</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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ulcer Healing</measure>
    <time_frame>8 weeks</time_frame>
    <description>as defined by follow-up endoscopy per gastroenterology service, 8 weeks after UGIB acute management</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of Rebleed</measure>
    <time_frame>8 weeks</time_frame>
    <description>Per patient report or as defined by follow-up endoscopy per gastroenterology service, 8 weeks after UGIB acute management&#xD;
High clinical suspicion of rebleed includes melena, hematochezia, confirmed by repeat endoscopy, requiring additional management</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clostridium Difficile Diarrhea</measure>
    <time_frame>8 weeks</time_frame>
    <description>Clostridium difficile confirmed by polymerase chain reaction (PCR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Community-Acquired Pneumonia</measure>
    <time_frame>8 weeks</time_frame>
    <description>As defined by clinical suspicion and/or positive sputum culture requiring antibiotic treatment</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Upper Gastrointestinal Bleed</condition>
  <arm_group>
    <arm_group_label>Pantoprazole twice daily</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Pantoprazole 40mg orally twice daily x 8 weeks after acute management of UGIB</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pantoprazole once daily</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Pantoprazole 40mg orally once daily x 8 weeks after acute management of UGIB</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pantoprazole</intervention_name>
    <description>Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB</description>
    <arm_group_label>Pantoprazole once daily</arm_group_label>
    <arm_group_label>Pantoprazole twice daily</arm_group_label>
    <other_name>Protonix</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult, 18 years and older; Upper GI bleed confirmed by endoscopy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Intensive Care Unit admission, Emergency endoscopic intervention required to control&#xD;
             bleeding, Malignant appearing ulcers as determined by endoscopy, Previous documented&#xD;
             treatment with twice daily PPI for other indication, Receiving twice daily PPI therapy&#xD;
             prior to admission&#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>Ashley M Ausmus, Pharm.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Missouri-Health Care</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital</name>
      <address>
        <city>Columbia</city>
        <state>Missouri</state>
        <zip>65112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Ali T, Roberts DN, Tierney WM. Long-term safety concerns with proton pump inhibitors. Am J Med. 2009 Oct;122(10):896-903. doi: 10.1016/j.amjmed.2009.04.014.</citation>
    <PMID>19786155</PMID>
  </reference>
  <reference>
    <citation>Masso Gonzalez EL, Garcia Rodriguez LA. Proton pump inhibitors reduce the long-term risk of recurrent upper gastrointestinal bleeding: an observational study. Aliment Pharmacol Ther. 2008 Sep 1;28(5):629-37. doi: 10.1111/j.1365-2036.2008.03780.x. Epub 2008 Jun 26.</citation>
    <PMID>18616644</PMID>
  </reference>
  <reference>
    <citation>Holster IL, Kuipers EJ. Management of acute nonvariceal upper gastrointestinal bleeding: current policies and future perspectives. World J Gastroenterol. 2012 Mar 21;18(11):1202-7. doi: 10.3748/wjg.v18.i11.1202.</citation>
    <PMID>22468083</PMID>
  </reference>
  <reference>
    <citation>Laine L, Jensen DM. Management of patients with ulcer bleeding. Am J Gastroenterol. 2012 Mar;107(3):345-60; quiz 361. doi: 10.1038/ajg.2011.480. Epub 2012 Feb 7.</citation>
    <PMID>22310222</PMID>
  </reference>
  <reference>
    <citation>Barkun AN, Bardou M, Kuipers EJ, Sung J, Hunt RH, Martel M, Sinclair P; International Consensus Upper Gastrointestinal Bleeding Conference Group. International consensus recommendations on the management of patients with nonvariceal upper gastrointestinal bleeding. Ann Intern Med. 2010 Jan 19;152(2):101-13. doi: 10.7326/0003-4819-152-2-201001190-00009.</citation>
    <PMID>20083829</PMID>
  </reference>
  <reference>
    <citation>Sheen E, Triadafilopoulos G. Adverse effects of long-term proton pump inhibitor therapy. Dig Dis Sci. 2011 Apr;56(4):931-50. doi: 10.1007/s10620-010-1560-3. Epub 2011 Mar 2.</citation>
    <PMID>21365243</PMID>
  </reference>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>September 5, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <results_first_submitted>April 26, 2017</results_first_submitted>
  <results_first_submitted_qc>May 31, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">July 2, 2017</results_first_posted>
  <last_update_submitted>June 29, 2017</last_update_submitted>
  <last_update_submitted_qc>June 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Proton pump inhibitor</keyword>
  <keyword>Upper gastrointestinal bleed</keyword>
  <keyword>Ulcer healing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastrointestinal Hemorrhage</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pantoprazole</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Three participants signed the consent form. One went on to complete the study; 1 was terminated by PI before starting the treatment and 1 was lost to follow-up before starting the treatment.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Pantoprazole Twice Daily</title>
          <description>Pantoprazole 40mg orally twice daily x 8 weeks after acute management of UGIB&#xD;
Pantoprazole: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB</description>
        </group>
        <group group_id="P2">
          <title>Pantoprazole Once Daily</title>
          <description>Pantoprazole 40mg orally once daily x 8 weeks after acute management of UGIB&#xD;
Pantoprazole: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Pantoprazole Twice Daily</title>
          <description>Pantoprazole 40mg orally twice daily x 8 weeks after acute management of UGIB&#xD;
Pantoprazole: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB</description>
        </group>
        <group group_id="B2">
          <title>Pantoprazole Once Daily</title>
          <description>Pantoprazole 40mg orally once daily x 8 weeks after acute management of UGIB&#xD;
Pantoprazole: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB</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="1"/>
            <count group_id="B2" value="0"/>
            <count group_id="B3" value="1"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Age &gt;18 years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="1"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="1"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</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>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </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 group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_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="1"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kg</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="1"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="140" lower_limit="140" upper_limit="140"/>
                    <measurement group_id="B3" value="140" lower_limit="140" upper_limit="140"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Glasgow-Blatchford Score</title>
          <description>Summary score of presenting symptoms ranging from 0 - 29 to assess the likelihood that a patient with an acute upper gastrointestinal bleeding will need to have medical intervention. Score of &gt;6 associated with higher risk of needing intervention.</description>
          <units>summary score</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="1"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17" spread="NA">Standard Deviation not calculable from one data value.</measurement>
                    <measurement group_id="B3" value="17" spread="NA">Standard Deviation not calculable from one data value.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Heart rate</title>
          <units>bpm</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="1"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="105" spread="NA">Standard Deviation not calculable form one data value.</measurement>
                    <measurement group_id="B3" value="105" spread="NA">Standard Deviation not calculable form one data value.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Participants with orthostasis</title>
          <description>Orthostasis is a decrease in blood pressure that happens soon after standing. Measured by taking blood pressure while seated and then on standing.</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="1"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Mean arterial pressure (MAP)</title>
          <units>mm Hg</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="1"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="76" spread="NA">Standard Deviation not calculable from one data value.</measurement>
                    <measurement group_id="B3" value="76" spread="NA">Standard Deviation not calculable from one data value.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Platelets</title>
          <units>Platelets/mm^3</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="1"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="299" spread="NA">Standard Deviation not calculable from one data value.</measurement>
                    <measurement group_id="B3" value="299" spread="NA">Standard Deviation not calculable from one data value.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Blood urea nitrogen (BUN)</title>
          <units>mg/dl</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="1"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25" spread="NA">Standard Deviation not calculable from one data value.</measurement>
                    <measurement group_id="B3" value="25" spread="NA">Standard Deviation not calculable from one data value.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Serum creatinine (SCr)</title>
          <units>mg/dL</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="1"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.7" spread="NA">Standard Deviation not calculable from one data value.</measurement>
                    <measurement group_id="B3" value="0.7" spread="NA">Standard Deviation not calculable from one data value.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Positive fecal occult blood test (FOBT)</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="1"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>H. pylori (serum) positive</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="1"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <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>Appearance of ulcer (clean-based)</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="1"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Appearance of ulcer (oozing, bleeding)</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="1"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Melena present</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="1"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hematemesis present</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="1"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Syncope</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="1"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hepatic disease</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="1"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>NSAID use</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="1"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Warfarin use</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="1"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Steroid use</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="1"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Novel oral anticoagulant (NOAC) use</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="1"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>smoker</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="1"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>alcoholism</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="1"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>history of ulcers</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="1"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>history of bleed</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="1"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>endoscopic intervention required</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="1"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>transfusion required</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="1"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Malignant cause identified</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="1"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Ulcer Healing</title>
        <description>as defined by follow-up endoscopy per gastroenterology service, 8 weeks after UGIB acute management</description>
        <time_frame>8 weeks</time_frame>
        <population>1 ulcer located in duodenum, clean-base; randomized single-blinded to proton pump inhibitor (PPI) twice daily</population>
        <group_list>
          <group group_id="O1">
            <title>Pantoprazole Twice Daily</title>
            <description>Pantoprazole 40mg orally twice daily x 8 weeks after acute management of UGIB&#xD;
Pantoprazole: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB</description>
          </group>
          <group group_id="O2">
            <title>Pantoprazole Once Daily</title>
            <description>Pantoprazole 40mg orally once daily x 8 weeks after acute management of UGIB&#xD;
Pantoprazole: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB</description>
          </group>
        </group_list>
        <measure>
          <title>Ulcer Healing</title>
          <description>as defined by follow-up endoscopy per gastroenterology service, 8 weeks after UGIB acute management</description>
          <population>1 ulcer located in duodenum, clean-base; randomized single-blinded to proton pump inhibitor (PPI) twice daily</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="1"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rate of Rebleed</title>
        <description>Per patient report or as defined by follow-up endoscopy per gastroenterology service, 8 weeks after UGIB acute management&#xD;
High clinical suspicion of rebleed includes melena, hematochezia, confirmed by repeat endoscopy, requiring additional management</description>
        <time_frame>8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pantoprazole Twice Daily</title>
            <description>Pantoprazole 40mg orally twice daily x 8 weeks after acute management of UGIB&#xD;
Pantoprazole: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB</description>
          </group>
          <group group_id="O2">
            <title>Pantoprazole Once Daily</title>
            <description>Pantoprazole 40mg orally once daily x 8 weeks after acute management of UGIB&#xD;
Pantoprazole: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Rebleed</title>
          <description>Per patient report or as defined by follow-up endoscopy per gastroenterology service, 8 weeks after UGIB acute management&#xD;
High clinical suspicion of rebleed includes melena, hematochezia, confirmed by repeat endoscopy, requiring additional management</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="1"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clostridium Difficile Diarrhea</title>
        <description>Clostridium difficile confirmed by polymerase chain reaction (PCR)</description>
        <time_frame>8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pantoprazole Twice Daily</title>
            <description>Pantoprazole 40mg orally twice daily x 8 weeks after acute management of UGIB&#xD;
Pantoprazole: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB</description>
          </group>
          <group group_id="O2">
            <title>Pantoprazole Once Daily</title>
            <description>Pantoprazole 40mg orally once daily x 8 weeks after acute management of UGIB&#xD;
Pantoprazole: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB</description>
          </group>
        </group_list>
        <measure>
          <title>Clostridium Difficile Diarrhea</title>
          <description>Clostridium difficile confirmed by polymerase chain reaction (PCR)</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="1"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Community-Acquired Pneumonia</title>
        <description>As defined by clinical suspicion and/or positive sputum culture requiring antibiotic treatment</description>
        <time_frame>8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pantoprazole Twice Daily</title>
            <description>Pantoprazole 40mg orally twice daily x 8 weeks after acute management of UGIB&#xD;
Pantoprazole: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB</description>
          </group>
          <group group_id="O2">
            <title>Pantoprazole Once Daily</title>
            <description>Pantoprazole 40mg orally once daily x 8 weeks after acute management of UGIB&#xD;
Pantoprazole: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB</description>
          </group>
        </group_list>
        <measure>
          <title>Community-Acquired Pneumonia</title>
          <description>As defined by clinical suspicion and/or positive sputum culture requiring antibiotic treatment</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="1"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>8 weeks after randomization</time_frame>
      <desc>no adverse events collected for the Pantoprazole Once Daily Arm/Group</desc>
      <group_list>
        <group group_id="E1">
          <title>Pantoprazole Twice Daily</title>
          <description>Pantoprazole 40mg orally twice daily x 8 weeks after acute management of UGIB&#xD;
Pantoprazole: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB</description>
        </group>
        <group group_id="E2">
          <title>Pantoprazole Once Daily</title>
          <description>Pantoprazole 40mg orally once daily x 8 weeks after acute management of UGIB&#xD;
Pantoprazole: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB</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="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </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="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </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>
    <limitations_and_caveats>trial eliminated due to very low enrollment Poorly adopted by GI department due to fears of using once daily PPI despite available evidence Need for expansion to more sites for better enrollment</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Ashley McCormick, PharmD, BCPS</name_or_title>
      <organization>University of Missouri - Columbia</organization>
      <phone>573-771-7798</phone>
      <email>ausmusash@health.missouri.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/NCT02235311
org study id: 1212917
nct id: NCT02235311
lead sponsor: 
has dmc: Yes
Despite recommendations from clinical practice guidelines to discharge patients from the
      hospital on once daily proton pump inhibitors after acute management of UGIB, clinical
      practice is to use twice daily proton pump inhibitor therapy. The objective of this study
      will be to assess whether or not once daily pantoprazole is non-inferior to twice daily
      pantoprazole in ulcer healing with a dose of once daily versus twice daily proton-pump
      inhibitor following an upper gastrointestinal bleed. Additionally, this study will observe
      for any potential difference in safety for once daily versus twice daily proton pump
      inhibitors.
There are few clinical practice guidelines for the management of a non-variceal, upper
      gastrointestinal bleed (UGIB). The 2012 guidelines released by the American College of
      Gastroenterology (ACG) indicate that for active bleeding or non-bleeding visible vessels or
      adherent clot, a bolus of 80 mg proton pump inhibitor followed by continuous infusion of 8
      mg/hr infusion is to be used. Following 72 hours of infusion therapy, an oral proton pump
      inhibitor (PPI) may be used. If the clot is a flat pigmented spot or a clean ulcer base, an
      oral proton pump inhibitor may be used for management (without infusion) (Laine 2012). There
      are no recommendations made on once versus twice daily proton pump inhibitor. The 2010
      American College of Physicians guideline recommends following the 72-hour infusion with
      once-daily proton pump inhibitors for duration as dictated by underlying etiology following
      upper gastrointestinal bleeding (UGIB) (Barkun 2012). This recommendation is graded 1C, with
      the decision to support once-daily over twice-daily dosing due to demonstrated effective
      ulcer healing for patients with peptic ulcer disease with once-daily dosing, and insufficient
      data to suggest twice-daily is superior to once-daily. There have been no head-to-head trials
      to evaluate once-daily versus twice-daily proton pump inhibitor following acute management of
      an endoscopic bleed. Additionally, studies suggest about 50% to 60% of proton pump inhibitors
      are being used without appropriate indications or at inappropriate dosages (Ali 2009).Safety
      concerns such as increased risk for Clostridium difficile infection , community acquired
      pneumonia, electrolyte abnormalities (hypomagnesemia), and fractures are becoming more
      prevalent warranting improved risk versus benefit examination of proton pump inhibitors
      including ascertainment of least effective dosing (Ali 2009, Sheen 2011). Despite
      recommendations to discharge patients after acute management of UGIB on once daily PPI
      therapy, clinical practice is to use twice daily proton pump inhibitor therapy. The objective
      of this study will be to examine if once daily pantoprazole is non-inferior to twice daily
      pantoprazole with regards to ulcer healing after acute management of an UGIB. In addition,
      because more evidence is emerging regarding safety concerns with proton pump inhibitors, the
      study will seek to examine if once daily versus twice daily therapy results in difference in
      safety or adverse reactions such as occurrence of rebleed, C. difficile diarrhea, or
      pneumonia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Ulcer Healing
time frame: 8 weeks
description: as defined by follow-up endoscopy per gastroenterology service, 8 weeks after UGIB acute management
measure: Rate of Rebleed
time frame: 8 weeks
description: Per patient report or as defined by follow-up endoscopy per gastroenterology service, 8 weeks after UGIB acute management
High clinical suspicion of rebleed includes melena, hematochezia, confirmed by repeat endoscopy, requiring additional management
measure: Clostridium Difficile Diarrhea
time frame: 8 weeks
description: Clostridium difficile confirmed by polymerase chain reaction (PCR)
measure: Community-Acquired Pneumonia
time frame: 8 weeks
description: As defined by clinical suspicion and/or positive sputum culture requiring antibiotic treatment
arm group label: Pantoprazole twice daily
arm group type: Active Comparator
description: Pantoprazole 40mg orally twice daily x 8 weeks after acute management of UGIB
arm group label: Pantoprazole once daily
arm group type: Active Comparator
description: Pantoprazole 40mg orally once daily x 8 weeks after acute management of UGIB
intervention type: Drug
intervention name: Pantoprazole
description: Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB
arm group label: Pantoprazole once daily
arm group label: Pantoprazole twice daily
other name: Protonix
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ashley M Ausmus, Pharm.D.
role: Principal Investigator
affiliation: University of Missouri-Health Care
facility: 
country: United States
citation: Ali T, Roberts DN, Tierney WM. Long-term safety concerns with proton pump inhibitors. Am J Med. 2009 Oct;122(10):896-903. doi: 10.1016/j.amjmed.2009.04.014.
PMID: 19786155
citation: Masso Gonzalez EL, Garcia Rodriguez LA. Proton pump inhibitors reduce the long-term risk of recurrent upper gastrointestinal bleeding: an observational study. Aliment Pharmacol Ther. 2008 Sep 1;28(5):629-37. doi: 10.1111/j.1365-2036.2008.03780.x. Epub 2008 Jun 26.
PMID: 18616644
citation: Holster IL, Kuipers EJ. Management of acute nonvariceal upper gastrointestinal bleeding: current policies and future perspectives. World J Gastroenterol. 2012 Mar 21;18(11):1202-7. doi: 10.3748/wjg.v18.i11.1202.
PMID: 22468083
citation: Laine L, Jensen DM. Management of patients with ulcer bleeding. Am J Gastroenterol. 2012 Mar;107(3):345-60; quiz 361. doi: 10.1038/ajg.2011.480. Epub 2012 Feb 7.
PMID: 22310222
citation: Barkun AN, Bardou M, Kuipers EJ, Sung J, Hunt RH, Martel M, Sinclair P; International Consensus Upper Gastrointestinal Bleeding Conference Group. International consensus recommendations on the management of patients with nonvariceal upper gastrointestinal bleeding. Ann Intern Med. 2010 Jan 19;152(2):101-13. doi: 10.7326/0003-4819-152-2-201001190-00009.
PMID: 20083829
citation: Sheen E, Triadafilopoulos G. Adverse effects of long-term proton pump inhibitor therapy. Dig Dis Sci. 2011 Apr;56(4):931-50. doi: 10.1007/s10620-010-1560-3. Epub 2011 Mar 2.
PMID: 21365243
responsible party type: Sponsor
mesh term: Gastrointestinal Hemorrhage
mesh term: Hemorrhage
mesh term: Pantoprazole
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: trial eliminated due to very low enrollment Poorly adopted by GI department due to fears of using once daily PPI despite available evidence Need for expansion to more sites for better enrollment
point of contact: 