<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/NCT01710800</url>
  </required_header>
  <id_info>
    <org_study_id>20593-8</org_study_id>
    <nct_id>NCT01710800</nct_id>
  </id_info>
  <brief_title>Twenty-Four Hour Combined Multi-Channel Impedance and pH Ambulatory Monitoring: Impedance Reflux Episodes of Patients On and Off Proton Pump Inhibitor Therapy</brief_title>
  <official_title>Twenty-Four Hour Combined Multi-Channel Impedance and pH Ambulatory Monitoring: Impedance Reflux Episodes of Patients On and Off Proton Pump Inhibitor Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Walter Reed National Military Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Walter Reed National Military Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the effects of proton pump inhibitors (PPIs) on the&#xD;
      total number of reflux episodes in the distal esophagus measured by impedance in patients&#xD;
      with and without gastroesophageal reflux disease (GERD) based on 24-hour pH testing. In&#xD;
      addition to changing the acidity of the refluxate, the investigators hypothesize that PPIs&#xD;
      also reduce the total number of reflux episodes due to its anti-secretory effects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2008</start_date>
  <completion_date type="Actual">September 2012</completion_date>
  <primary_completion_date type="Actual">September 2012</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>Crossover Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Impedance Episodes Following PPI and Placebo</measure>
    <time_frame>1 week</time_frame>
    <description>Impedance is defined as a 50% decrease from baseline in retrograde movement of liquid from the stomach to the esophagus. In other words, it measures the number of retrograde reflux episodes.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">41</enrollment>
  <condition>GERD</condition>
  <arm_group>
    <arm_group_label>Placebo arm</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients will be randomized to receive either PPI or placebo and then undergo a 24 hour pH study with impedance to measure the number of reflux episodes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Esomeprazole</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients were randomly assigned to receive 40 mg esomeprazole twice daily prior to undergoing a 24 hour pH study with impedance to measure the number of reflux episodes</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Esomeprazole</intervention_name>
    <arm_group_label>Esomeprazole</arm_group_label>
    <other_name>Nexium</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <arm_group_label>Placebo arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All adults patients (age 18 or older) with reflux symptoms willing to participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Prior esophageal or gastric surgery&#xD;
&#xD;
          -  Achalasia&#xD;
&#xD;
          -  Scleroderma&#xD;
&#xD;
          -  Gastroparesis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>October 17, 2012</study_first_submitted>
  <study_first_submitted_qc>October 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 19, 2012</study_first_posted>
  <results_first_submitted>October 24, 2012</results_first_submitted>
  <results_first_submitted_qc>January 8, 2013</results_first_submitted_qc>
  <results_first_posted type="Estimate">January 9, 2013</results_first_posted>
  <last_update_submitted>January 8, 2013</last_update_submitted>
  <last_update_submitted_qc>January 8, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 9, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Walter Reed National Military Medical Center</investigator_affiliation>
    <investigator_full_name>Fouad Moawad</investigator_full_name>
    <investigator_title>Gastroenterologist</investigator_title>
  </responsible_party>
  <keyword>impedance</keyword>
  <keyword>reflux</keyword>
  <keyword>GERD</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Esomeprazole</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>All eligible patients with suspected GERD will be referred to the manometry and reflux lab testing for potential recruitment into the study</recruitment_details>
      <pre_assignment_details>Prior to undergoing 24 hour pH with impedance, all participants will receive either one week of esomeprazole or one week of placebo.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>First Intervention (7 Days), Second Intervention (7 Days)</title>
          <description>Patients will be randomized to receive either PPI or placebo (sequence 1) for 7 days and then undergo a 24 hour pH study with impedance to measure the number of reflux episode. The second sequence of medications (that is either placebo or PPI or sequence 2) will be administered followed by repeat 24 hour pH with impedance 7 days later.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="63">63 patients consented to be part of the study</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received PPI Intervention</title>
              <participants_list>
                <participants group_id="P1" count="44"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received Placebo Intervention</title>
              <participants_list>
                <participants group_id="P1" count="45"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="41">22 drop outs(consented but did not participate, refused 2nd intervention)</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>All Study Participants</title>
          <description>Patients will be randomized to receive either PPI or placebo (sequence 1) and then undergo a 24 hour pH study with impedance to measure the number of reflux episodes. Sequence 2 (placebo or PPI) will be administered followed by repeat 24 hour pH with impedance.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="41"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52" spread="12"/>
                  </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="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </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>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Impedance Episodes Following PPI and Placebo</title>
        <description>Impedance is defined as a 50% decrease from baseline in retrograde movement of liquid from the stomach to the esophagus. In other words, it measures the number of retrograde reflux episodes.</description>
        <time_frame>1 week</time_frame>
        <population>We analyzed as per protocol. Only patients who completed both 24 hour pH studies with impedance were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Arm</title>
            <description>Patients will be randomized to receive either PPI or placebo and then undergo a 24 hour pH study with impedance to measure the number of reflux episodes</description>
          </group>
          <group group_id="O2">
            <title>Esomeprazole</title>
            <description>Patients were randomly assigned to receive 40 mg esomeprazole twice daily prior to undergoing a 24 hour pH study with impedance to measure the number of reflux episodes</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Impedance Episodes Following PPI and Placebo</title>
          <description>Impedance is defined as a 50% decrease from baseline in retrograde movement of liquid from the stomach to the esophagus. In other words, it measures the number of retrograde reflux episodes.</description>
          <population>We analyzed as per protocol. Only patients who completed both 24 hour pH studies with impedance were analyzed.</population>
          <units>number of episodes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
                <count group_id="O2" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47" spread="22"/>
                    <measurement group_id="O2" value="53" spread="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>One week</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Placebo Arm</title>
        </group>
        <group group_id="E2">
          <title>PPI Arm</title>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="45"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="44"/>
              </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="45"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Single center study. Relatively small number of patients studied, although recruitment goal reached.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Fouad J. Moawad</name_or_title>
      <organization>Walter Reed National Military Medical Center</organization>
      <phone>(301) 400-1551</phone>
      <email>Fouad.Moawad@us.army.mil</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/NCT01710800
org study id: 20593-8
nct id: NCT01710800
lead sponsor: 
has dmc: Yes
The purpose of this study is to determine the effects of proton pump inhibitors (PPIs) on the
      total number of reflux episodes in the distal esophagus measured by impedance in patients
      with and without gastroesophageal reflux disease (GERD) based on 24-hour pH testing. In
      addition to changing the acidity of the refluxate, the investigators hypothesize that PPIs
      also reduce the total number of reflux episodes due to its anti-secretory effects.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Diagnostic
masking: Double (Participant, Investigator)
measure: Number of Impedance Episodes Following PPI and Placebo
time frame: 1 week
description: Impedance is defined as a 50% decrease from baseline in retrograde movement of liquid from the stomach to the esophagus. In other words, it measures the number of retrograde reflux episodes.
arm group label: Placebo arm
arm group type: Placebo Comparator
description: Patients will be randomized to receive either PPI or placebo and then undergo a 24 hour pH study with impedance to measure the number of reflux episodes
arm group label: Esomeprazole
arm group type: Active Comparator
description: Patients were randomly assigned to receive 40 mg esomeprazole twice daily prior to undergoing a 24 hour pH study with impedance to measure the number of reflux episodes
intervention type: Drug
intervention name: Esomeprazole
arm group label: Esomeprazole
other name: Nexium
intervention type: Drug
intervention name: placebo
arm group label: Placebo arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Walter Reed National Military Medical Center
investigator full name: Fouad Moawad
investigator title: Gastroenterologist
mesh term: Esomeprazole
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Single center study. Relatively small number of patients studied, although recruitment goal reached.
point of contact: 