<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/NCT02197143</url>
  </required_header>
  <id_info>
    <org_study_id>MDhayri84</org_study_id>
    <secondary_id>120841</secondary_id>
    <nct_id>NCT02197143</nct_id>
  </id_info>
  <brief_title>A Comparison of Efficacy of Intravenous Esomeprazole and Ranitidine Treatment of Dyspeptic Pain</brief_title>
  <official_title>A Comparison of Efficacy of Intravenous Esomeprazole and Ranitidine Treatment of Dyspeptic Pain: A Double-Blind, Randomized, Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pamukkale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pamukkale University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      -  Currently, Proton Pump Inhibitors and H2Receptor Blockers are widely used by emergency&#xD;
           physicians in Turkey for the treatment of patients with dyspepsia.&#xD;
&#xD;
        -  The objective of the study was to assess whether intravenous esomeprazol has superior&#xD;
           dyspeptic pain reduction compared with ranitidine or hydrotalcid in emergency department&#xD;
           (ED) adults&#xD;
&#xD;
        -  The investigators second aim was to compare recurrent dyspeptic pain within 24 hours&#xD;
           after discharge and cost of treatments in the treatment of dyspepsia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  this is the placebo randomized double blinded clinical trial to compare the efficacy of&#xD;
           these three drugs in this clinical setting.&#xD;
&#xD;
        -  A randomized clinical trial was conducted in the ED of Pamukkale University Medical&#xD;
           Faculty Hospital&#xD;
&#xD;
        -  Study personnel (emergency physicians and nurses) were trained before the study.&#xD;
&#xD;
        -  When intravenous drugs (esomeprazol, ranitidine or plasebo) was being recommended, an&#xD;
           eligibility checklist was completed by the attending physician.&#xD;
&#xD;
        -  If there were no exclusion criteria, written informed consent was obtained and baseline&#xD;
           information, including initial dispeptic pain severity ratings with VAS were recorded.&#xD;
&#xD;
        -  The need for identification and enrollment of participants by staff with conflicting&#xD;
           work pressures resulted in recruitment of a convenience sample of patients.&#xD;
&#xD;
        -  All patients eligible for the study were randomized to one of three groups:&#xD;
&#xD;
        -  First Group: 40 mg Esomeprozol with 5 cc syringe in 150 ml normal saline given as a slow&#xD;
           intravenous infusion over 15 minutes and p.o. 10ml Hidrotalcid&#xD;
&#xD;
        -  Second Group: 50mg Ranitidin with 5 cc syringe in 150 ml normal saline given as a slow&#xD;
           intravenous infusion over 15 minutes and p.o. 10ml Hidrotalcid&#xD;
&#xD;
        -  Third Group: 150 ml only normal saline given as a slow intravenous infusion over 15&#xD;
           minutes and p.o. 10ml Hidrotalcid&#xD;
&#xD;
        -  Drug packs prepared in 5 ml syringes were numbered by an independent nurse, who not&#xD;
           involved in the study.&#xD;
&#xD;
        -  Drug packs were prepared according to the computer-generated random number sequence to&#xD;
           assign treatment allocations&#xD;
&#xD;
        -  The allocation list was kept by the emergency nurse. Patients received the esomeprazol,&#xD;
           the ranitidin or the placebo medication schemes according to their random allocations.&#xD;
&#xD;
        -  After enrollment and recording of baseline information, the next numbered study drug&#xD;
           pack was obtained, and administered as a infusion over 15 minutes.&#xD;
&#xD;
        -  Randomization was achieved by using computer software to generate random numbers. During&#xD;
           the intervention, participants were monitored by an oxygen saturation (SpO2) monitor, an&#xD;
           automatic sphygmomanometer (blood pressure), and a rhythm monitor (heart rate and&#xD;
           rhythms)&#xD;
&#xD;
        -  One researcher blinded to patient allocation observed the whole procedure and recorded&#xD;
           the dyspeptic pain scores.&#xD;
&#xD;
        -  Patients in both groups received three types of medication in a similar manner (for&#xD;
           example, 150 ml normal saline given as a slow intravenous infusion over 15 minutes),&#xD;
           thus ensuring double blinding.&#xD;
&#xD;
        -  Dyspeptic pain scores were recorded at 0, 15, 30, 45 and 60 min on a VAS of 1 to 10&#xD;
&#xD;
        -  Rescue medication [hidrotalcid 10ml (Talcid, Bayer, Istanbul, Turkey)] was given&#xD;
           intravenously to patients if dyspeptic pain VAS scores ≥ 5 in thirty minutes after study&#xD;
           drug administration.&#xD;
&#xD;
        -  All other medications required during the study also were recorded.&#xD;
&#xD;
        -  During the study, pulse rate, systolic blood pressure, diastolic blood pressure,&#xD;
           respiration rate and oxygen saturation (SpO2) were recorded at baseline (0 min), 15, 30,&#xD;
           and 60 min.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2013</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">July 2014</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>compare the effects of intravenous esomeprazol and ranitidin for the treatment of dyspepsia in the emergency setting.</measure>
    <time_frame>Patients in both groups received three types of medication than dyspeptic pain scores were recorded at 0, 15, 30, 45 and 60 min on a VAS of 1 to 10.</time_frame>
    <description>This work took 17 months</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">286</enrollment>
  <condition>Dyspepsia</condition>
  <arm_group>
    <arm_group_label>Esomeprazole</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>40 mg Esomeprazole in 150 ml normal saline given as a slow intravenous infusion over 15 minutes and p.o. 10ml Hydrotalcid</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ranitidine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>50mg Ranitidine in 150 ml normal saline given as a slow intravenous infusion over 15 minutes and p.o. 10ml Hydrotalcid</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>150 ml only normal saline given as a slow intravenous infusion over 15 minutes and p.o. 10ml Hydrotalcid</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>esomeprazole</intervention_name>
    <description>40 mg esomeprazole in 150 ml normal saline given as a slow intravenous infusion over 15 minutes and p.o. 10ml Hydrotalcid</description>
    <arm_group_label>Esomeprazole</arm_group_label>
    <arm_group_label>Ranitidine</arm_group_label>
    <other_name>Nexium, Astra Zeneca drugs, Södertalje</other_name>
    <other_name>Esmara</other_name>
    <other_name>Esom</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ranitidine</intervention_name>
    <description>50mg Ranitidine in 150 ml normal saline given as a slow intravenous infusion over 15 minutes and p.o. 10ml Hydrotalcid</description>
    <arm_group_label>Ranitidine</arm_group_label>
    <arm_group_label>placebo</arm_group_label>
    <other_name>Ulcuran, Abfar drugs, Istanbul</other_name>
    <other_name>Ranitab</other_name>
    <other_name>Ultidin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>hydrotalcid</intervention_name>
    <description>150 ml only normal saline given as a slow intravenous infusion over 15 minutes and p.o. 10ml Hydrotalcid</description>
    <arm_group_label>Esomeprazole</arm_group_label>
    <arm_group_label>placebo</arm_group_label>
    <other_name>Talcid, Bayer, Istanbul</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients were eligible for inclusion if they were aged 18 years or older, 60 years or&#xD;
             older,&#xD;
&#xD;
          -  had dyspspsia [VAS (visual analog scale) score &gt;5] during their ED episode of care for&#xD;
             which the attending physician recommended medication.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pretreatment 100-mm linear visual analog scale (VAS) pain score less than 50 mm;&#xD;
&#xD;
          -  known cases of malignancy or terminal illness;&#xD;
&#xD;
          -  known cases of major medical problems (eg, any evidence of active structural or&#xD;
             functional abnormality of the hearts, chronic renal failure)&#xD;
&#xD;
          -  allergy or previous adverse reaction to study drugs studied&#xD;
&#xD;
          -  received agents to inhibit the secretion of acid (PPIs or histamine-2 receptor&#xD;
             antagonists), nonsteroidal anti-inflammatory drugs,&#xD;
&#xD;
          -  who consumed alcohol within 4 hours before the ED visit&#xD;
&#xD;
          -  diarrhea more than 2 times within the past 24 hours;&#xD;
&#xD;
          -  being suspected to have other ED diagnoses (eg, gut obstruction, biliary colic,&#xD;
             pancreatitis, hepatitis, or localized hepatobiliary infections);&#xD;
&#xD;
          -  being pregnant or breast-feeding; and&#xD;
&#xD;
          -  inability to comprehend the VAS evaluation.&#xD;
&#xD;
          -  and patients who refused to participate study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>hayri elicabuk, md</last_name>
    <role>Principal Investigator</role>
    <affiliation>pamukkale universty</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pamukkale Universty</name>
      <address>
        <city>Denizli</city>
        <zip>20000</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 9, 2014</study_first_submitted>
  <study_first_submitted_qc>July 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <last_update_submitted>July 18, 2014</last_update_submitted>
  <last_update_submitted_qc>July 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 22, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Pamukkale University</investigator_affiliation>
    <investigator_full_name>hayri elicabuk</investigator_full_name>
    <investigator_title>md</investigator_title>
  </responsible_party>
  <keyword>esomeprazole</keyword>
  <keyword>ranitidine</keyword>
  <keyword>hydrotalcid</keyword>
  <keyword>treatment of dyspepsia</keyword>
  <keyword>emergancy medicine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dyspepsia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Esomeprazole</mesh_term>
    <mesh_term>Ranitidine</mesh_term>
    <mesh_term>Ranitidine bismuth citrate</mesh_term>
  </intervention_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/NCT02197143
org study id: MDhayri84
secondary id: 120841
nct id: NCT02197143
lead sponsor: 
has dmc: Yes
-  Currently, Proton Pump Inhibitors and H2Receptor Blockers are widely used by emergency
           physicians in Turkey for the treatment of patients with dyspepsia.

        -  The objective of the study was to assess whether intravenous esomeprazol has superior
           dyspeptic pain reduction compared with ranitidine or hydrotalcid in emergency department
           (ED) adults

        -  The investigators second aim was to compare recurrent dyspeptic pain within 24 hours
           after discharge and cost of treatments in the treatment of dyspepsia.
-  this is the placebo randomized double blinded clinical trial to compare the efficacy of
           these three drugs in this clinical setting.

        -  A randomized clinical trial was conducted in the ED of Pamukkale University Medical
           Faculty Hospital

        -  Study personnel (emergency physicians and nurses) were trained before the study.

        -  When intravenous drugs (esomeprazol, ranitidine or plasebo) was being recommended, an
           eligibility checklist was completed by the attending physician.

        -  If there were no exclusion criteria, written informed consent was obtained and baseline
           information, including initial dispeptic pain severity ratings with VAS were recorded.

        -  The need for identification and enrollment of participants by staff with conflicting
           work pressures resulted in recruitment of a convenience sample of patients.

        -  All patients eligible for the study were randomized to one of three groups:

        -  First Group: 40 mg Esomeprozol with 5 cc syringe in 150 ml normal saline given as a slow
           intravenous infusion over 15 minutes and p.o. 10ml Hidrotalcid

        -  Second Group: 50mg Ranitidin with 5 cc syringe in 150 ml normal saline given as a slow
           intravenous infusion over 15 minutes and p.o. 10ml Hidrotalcid

        -  Third Group: 150 ml only normal saline given as a slow intravenous infusion over 15
           minutes and p.o. 10ml Hidrotalcid

        -  Drug packs prepared in 5 ml syringes were numbered by an independent nurse, who not
           involved in the study.

        -  Drug packs were prepared according to the computer-generated random number sequence to
           assign treatment allocations

        -  The allocation list was kept by the emergency nurse. Patients received the esomeprazol,
           the ranitidin or the placebo medication schemes according to their random allocations.

        -  After enrollment and recording of baseline information, the next numbered study drug
           pack was obtained, and administered as a infusion over 15 minutes.

        -  Randomization was achieved by using computer software to generate random numbers. During
           the intervention, participants were monitored by an oxygen saturation (SpO2) monitor, an
           automatic sphygmomanometer (blood pressure), and a rhythm monitor (heart rate and
           rhythms)

        -  One researcher blinded to patient allocation observed the whole procedure and recorded
           the dyspeptic pain scores.

        -  Patients in both groups received three types of medication in a similar manner (for
           example, 150 ml normal saline given as a slow intravenous infusion over 15 minutes),
           thus ensuring double blinding.

        -  Dyspeptic pain scores were recorded at 0, 15, 30, 45 and 60 min on a VAS of 1 to 10

        -  Rescue medication [hidrotalcid 10ml (Talcid, Bayer, Istanbul, Turkey)] was given
           intravenously to patients if dyspeptic pain VAS scores ≥ 5 in thirty minutes after study
           drug administration.

        -  All other medications required during the study also were recorded.

        -  During the study, pulse rate, systolic blood pressure, diastolic blood pressure,
           respiration rate and oxygen saturation (SpO2) were recorded at baseline (0 min), 15, 30,
           and 60 min.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: compare the effects of intravenous esomeprazol and ranitidin for the treatment of dyspepsia in the emergency setting.
time frame: Patients in both groups received three types of medication than dyspeptic pain scores were recorded at 0, 15, 30, 45 and 60 min on a VAS of 1 to 10.
description: This work took 17 months
arm group label: Esomeprazole
arm group type: Experimental
description: 40 mg Esomeprazole in 150 ml normal saline given as a slow intravenous infusion over 15 minutes and p.o. 10ml Hydrotalcid
arm group label: Ranitidine
arm group type: Experimental
description: 50mg Ranitidine in 150 ml normal saline given as a slow intravenous infusion over 15 minutes and p.o. 10ml Hydrotalcid
arm group label: placebo
arm group type: Experimental
description: 150 ml only normal saline given as a slow intravenous infusion over 15 minutes and p.o. 10ml Hydrotalcid
intervention type: Drug
intervention name: esomeprazole
description: 40 mg esomeprazole in 150 ml normal saline given as a slow intravenous infusion over 15 minutes and p.o. 10ml Hydrotalcid
arm group label: Esomeprazole
arm group label: Ranitidine
other name: Nexium, Astra Zeneca drugs, Södertalje
other name: Esmara
other name: Esom
intervention type: Drug
intervention name: Ranitidine
description: 50mg Ranitidine in 150 ml normal saline given as a slow intravenous infusion over 15 minutes and p.o. 10ml Hydrotalcid
arm group label: Ranitidine
arm group label: placebo
other name: Ulcuran, Abfar drugs, Istanbul
other name: Ranitab
other name: Ultidin
intervention type: Drug
intervention name: hydrotalcid
description: 150 ml only normal saline given as a slow intravenous infusion over 15 minutes and p.o. 10ml Hydrotalcid
arm group label: Esomeprazole
arm group label: placebo
other name: Talcid, Bayer, Istanbul
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: hayri elicabuk, md
role: Principal Investigator
affiliation: pamukkale universty
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Pamukkale University
investigator full name: hayri elicabuk
investigator title: md
mesh term: Dyspepsia
mesh term: Esomeprazole
mesh term: Ranitidine
mesh term: Ranitidine bismuth citrate