<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/NCT04407832</url>
  </required_header>
  <id_info>
    <org_study_id>lowdosePPI</org_study_id>
    <nct_id>NCT04407832</nct_id>
  </id_info>
  <brief_title>Comparing Two Doses of IV Esomeprazole After Successful Endoscopic Therapy</brief_title>
  <acronym>lowdosePPI</acronym>
  <official_title>A Double Blind Study Comparing Low Dose and High Dose IV Esomeprazole After Successful Endoscopic Therapy in Patients With Peptic Ulcer Bleeding</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Changhua Christian Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Taipei Medical University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dalin Tzu Chi General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Changhua Christian Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators used two different doses of esomeprazole (40 mg IV q.d. and 40 mg IV q6h&#xD;
      for three days followed by esomeprazole 40 mg q.d. orally in two groups) after successful&#xD;
      endoscopic therapy with heat probe therapy or hemoclip placement.&#xD;
&#xD;
      The goal of this study is to assess the outcomes of two different regimens of low vs. high&#xD;
      dose of intravenous esomeprazole after endoscopic therapy in patients with peptic ulcer&#xD;
      bleeding.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A bleeding peptic ulcer remains a serious medical problem with significant morbidity and&#xD;
      mortality. Endoscopic therapy significantly reduces further bleeding, surgery, and mortality&#xD;
      in patients receiving intravenous Proton Pump Inhibitor (PPI）and is now recommended as the&#xD;
      first hemostatic modality for these patients. In the past few years, adjuvant use of a&#xD;
      high-dose proton pump inhibitor (PPI) after endoscopic therapy has been endorsed in some&#xD;
      studies, including two consensus statements and two meta-analysis. To sustain a high&#xD;
      intragastric pH, a high dose of omeprazole has been used in previous studies concerning&#xD;
      high-risk peptic ulcer bleeding. However, in one recent published metaanalysis found that low&#xD;
      dose PPI may be as effective as high dose PPI in preventing further bleeding in high-risk&#xD;
      patients. Therefore, one double blind study is needed clarify this puzzle.&#xD;
&#xD;
      We used two different doses of esomeprazole (40 mg IV q.d. and 40 mg IV q6h for three days&#xD;
      followed by esomeprazole 40 mg q.d. orally in two groups) after successful endoscopic therapy&#xD;
      with heat probe therapy or hemoclip placement.&#xD;
&#xD;
      The goal of this study is to assess the outcomes of two different regimens of low vs. high&#xD;
      dose of intravenous esomeprazole after endoscopic therapy in patients with peptic ulcer&#xD;
      bleeding.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <start_date>August 2011</start_date>
  <completion_date type="Anticipated">September 2013</completion_date>
  <primary_completion_date type="Anticipated">July 2013</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>further bleeding</measure>
    <time_frame>14 days</time_frame>
    <description>Number of participants with rebleeding within 14 days</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>hospital stay</measure>
    <time_frame>30 days</time_frame>
    <description>hospital stay in day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>need of blood transfusion</measure>
    <time_frame>30 days</time_frame>
    <description>number of participants need of blood transufion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>surgical intervention</measure>
    <time_frame>30 days</time_frame>
    <description>number of participants need surgical intervention to manage bleeding</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mortality</measure>
    <time_frame>30 days</time_frame>
    <description>number of participants death</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Peptic Ulcer Bleeding</condition>
  <arm_group>
    <arm_group_label>low dose PPI</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>40 mg esomeprazole IV for three days followed by esomeprazole 40 mg po daily for two months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>high dose PPI</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>40 mg esomeprazole IV every 6 hr for 3 days followed by 40 mg po daily for two months</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>heat probe or hemoclip</intervention_name>
    <description>for hemostasis</description>
    <arm_group_label>low dose PPI</arm_group_label>
    <other_name>Olympus co.</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>heat probe or hemoclip</intervention_name>
    <description>for hemostasis</description>
    <arm_group_label>high dose PPI</arm_group_label>
    <other_name>Olympus co.</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with peptic ulcer bleeding with active bleeding or nonbleeding visible&#xD;
             (initial Hb&lt;10, shock, or coffee grounds or blood in stomach)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age &gt;90y/o&#xD;
&#xD;
          -  pregnant woman&#xD;
&#xD;
          -  allergic to esomeprazole&#xD;
&#xD;
          -  unwilling to enter this study&#xD;
&#xD;
          -  bleeding tendency&#xD;
&#xD;
          -  severe co-morbid illness, including cancer, hepatic failure, renal failure,&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hwai-jeng Lin, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Taipei Medical University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Division of Gastroenterology, TMUH</name>
      <address>
        <city>Taipei</city>
        <zip>110</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>August 4, 2011</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>May 27, 2020</last_update_submitted>
  <last_update_submitted_qc>May 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>hemostasis</keyword>
  <keyword>heat probe</keyword>
  <keyword>hemoclip</keyword>
  <keyword>rebleeding</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peptic Ulcer</mesh_term>
    <mesh_term>Peptic Ulcer Hemorrhage</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04407832
org study id: lowdosePPI
nct id: NCT04407832
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The investigators used two different doses of esomeprazole (40 mg IV q.d. and 40 mg IV q6h
      for three days followed by esomeprazole 40 mg q.d. orally in two groups) after successful
      endoscopic therapy with heat probe therapy or hemoclip placement.

      The goal of this study is to assess the outcomes of two different regimens of low vs. high
      dose of intravenous esomeprazole after endoscopic therapy in patients with peptic ulcer
      bleeding.
A bleeding peptic ulcer remains a serious medical problem with significant morbidity and
      mortality. Endoscopic therapy significantly reduces further bleeding, surgery, and mortality
      in patients receiving intravenous Proton Pump Inhibitor (PPI）and is now recommended as the
      first hemostatic modality for these patients. In the past few years, adjuvant use of a
      high-dose proton pump inhibitor (PPI) after endoscopic therapy has been endorsed in some
      studies, including two consensus statements and two meta-analysis. To sustain a high
      intragastric pH, a high dose of omeprazole has been used in previous studies concerning
      high-risk peptic ulcer bleeding. However, in one recent published metaanalysis found that low
      dose PPI may be as effective as high dose PPI in preventing further bleeding in high-risk
      patients. Therefore, one double blind study is needed clarify this puzzle.

      We used two different doses of esomeprazole (40 mg IV q.d. and 40 mg IV q6h for three days
      followed by esomeprazole 40 mg q.d. orally in two groups) after successful endoscopic therapy
      with heat probe therapy or hemoclip placement.

      The goal of this study is to assess the outcomes of two different regimens of low vs. high
      dose of intravenous esomeprazole after endoscopic therapy in patients with peptic ulcer
      bleeding.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: further bleeding
time frame: 14 days
description: Number of participants with rebleeding within 14 days
measure: hospital stay
time frame: 30 days
description: hospital stay in day
measure: need of blood transfusion
time frame: 30 days
description: number of participants need of blood transufion
measure: surgical intervention
time frame: 30 days
description: number of participants need surgical intervention to manage bleeding
measure: mortality
time frame: 30 days
description: number of participants death
arm group label: low dose PPI
arm group type: Active Comparator
description: 40 mg esomeprazole IV for three days followed by esomeprazole 40 mg po daily for two months
arm group label: high dose PPI
arm group type: Active Comparator
description: 40 mg esomeprazole IV every 6 hr for 3 days followed by 40 mg po daily for two months
intervention type: Device
intervention name: heat probe or hemoclip
description: for hemostasis
arm group label: low dose PPI
other name: Olympus co.
intervention type: Device
intervention name: heat probe or hemoclip
description: for hemostasis
arm group label: high dose PPI
other name: Olympus co.
criteria: 
gender: All
minimum age: 18 Years
maximum age: 89 Years
healthy volunteers: No
last name: Hwai-jeng Lin, M.D.
role: Principal Investigator
affiliation: Taipei Medical University Hospital
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Peptic Ulcer
mesh term: Peptic Ulcer Hemorrhage
mesh term: Hemorrhage