<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/NCT03037606</url>
  </required_header>
  <id_info>
    <org_study_id>NEU-03.16</org_study_id>
    <nct_id>NCT03037606</nct_id>
  </id_info>
  <brief_title>Comparison of the Effect of Rabeprazole 50 mg DDR Capsules and 20 mg Enteric-coated Tablets</brief_title>
  <official_title>Comparison of the Effect of Rabeprazole 50 mg DDR Capsules and 20 mg Enteric-coated Tablets on Intragastric and Intraesophageal Acidity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Neutec Ar-Ge San ve Tic A.Ş</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Neutec Ar-Ge San ve Tic A.Ş</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      It is planned to compare the efficacy and safety of rabeprazole 50 mg DDR (dual delayed&#xD;
      release) capsules versus rabeprazole 20 mg enteric coated tablets administered once daily in&#xD;
      patients with Gastroesophageal Reflux Disease (GERD).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">December 11, 2018</completion_date>
  <primary_completion_date type="Actual">December 1, 2018</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage time of 24-hour intragastric pH &gt;4 compared to baseline</measure>
    <time_frame>7 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC of 24-hour intragastric pH &gt;4 compared to baseline</measure>
    <time_frame>7 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Significant increase in total measurements of median pH</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Significant increase in nocturnal measurements of median pH</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Decrease in reflux symptom index calculated by weekly regurgitation numbers</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Decrease in reflux symptom index calculated by weekly pyrosis numbers</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage time of 24-hour intragastric pH &gt;2 compared to baseline</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage time of 24-hour intragastric pH &gt;6 compared to baseline</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC of 24-hour intragastric pH &gt;2 compared to baseline</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC of 24-hour intragastric pH &gt;6 compared to baseline</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage time of 24-hour total intragastric pH &gt;4 compared to baseline</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC of 24-hour total intragastric pH &gt;4 compared to baseline</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage time of 24-hour total intragastric pH &gt;4 between 11 pm and 7 am compared to baseline baseline</measure>
    <time_frame>7 days</time_frame>
    <description>rate of night reflux</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC of of 24-hour total intragastric pH &gt;4 between 11 pm and 7 am compared to baseline</measure>
    <time_frame>7 days</time_frame>
    <description>rate of night reflux</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The evaluation of safety of study drug (Number of Participants with Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatments)</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in QT interval obtained by ECG compared to baseline</measure>
    <time_frame>21 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Gastroesophageal Reflux Disease</condition>
  <arm_group>
    <arm_group_label>Rabelis DDR 50 mg Capsules and 1 placebo tablet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Placebo as comparator group is not used. Since study is double-blind, one placebo capsule and tablet is added to treatment groups in order to remove the discrepancy between investigational products.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pariet 20 mg Enteric Coated Tablets and 1 placebo capsule</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Placebo as comparator group is not used. Since study is double-blind, one placebo capsule and tablet is added to treatment groups in order to remove the discrepancy between investigational products.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rabelis DDR 50 mg Capsules</intervention_name>
    <description>Rabelis DDR 50 mg Capsules once daily for seven days.</description>
    <arm_group_label>Rabelis DDR 50 mg Capsules and 1 placebo tablet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pariet 20 mg Enteric Coated Tablets</intervention_name>
    <description>Pariet 20 mg Enteric Coated Tablets once daily for seven days.</description>
    <arm_group_label>Pariet 20 mg Enteric Coated Tablets and 1 placebo capsule</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of GERD with symptoms (i.e. regurgitation, pyrosis) at least 1 or more&#xD;
             episodes a week.&#xD;
&#xD;
          -  Age ≥ 18 years and &lt;65 years&#xD;
&#xD;
          -  Helicobacter pylori (an infection) negative&#xD;
&#xD;
          -  Have a body mass index (BMI) between 18 and 33 kg/m²&#xD;
&#xD;
          -  pH&gt;4 gastric exposure &lt;25% on a 24-hour dual pH channel monitoring study performed&#xD;
             prior to screening (normal intragastric pH +2SD)&#xD;
&#xD;
          -  Pathologic intraesophageal acidity exposure (DeMeester score &gt;14.75 and/or &gt;4% of pH&lt;4&#xD;
             (at least 21 hours measured)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patiets with Barrett's stricture, gastric outlet obstruction, malignancy,&#xD;
             gastrointestinal system bleeding or any other upper gastrointestinal system pathology.&#xD;
&#xD;
          -  Patients whose Hiatus hernia is &gt; 3 cm.&#xD;
&#xD;
          -  Patients with uncontrolled or insulin dependent diabetes mellitus, symptomatic&#xD;
             gallbladder stone, active or unhealed stomach or duodenum ulcer, Zollinger-Ellison&#xD;
             syndrome, primary esophagus motility disorder, pancreatitis, inflammatory bowel&#xD;
             disease, severe lung disease, chronic liver disease, uncontrolled kidney impairment,&#xD;
             cancer (except skin cancer except melanoma), cerebrovascular disease, epilepsy.&#xD;
&#xD;
          -  Patients with history of heart failure, ventricular tachycardia, ventricular&#xD;
             fibrillation, cardiac arrest, Torsades de pointes, bradycardia, sinus node&#xD;
             dysfunction, heart attack, long QTc (&gt;450 ms for male, &gt;470 ms for female patients).&#xD;
&#xD;
          -  Patients taken PPIs or H2-blockers within 7 days and prokinetic drugs within 3 days&#xD;
             before entering the study.&#xD;
&#xD;
          -  Patients with major psychiatric disease.&#xD;
&#xD;
          -  Alcoholism and drug use.&#xD;
&#xD;
          -  Patients with pathologic laboratory tests; hemogram, sedimentation, CRP, thyroid&#xD;
             functions tests, liver enzymes.&#xD;
&#xD;
          -  Malabsorbtion.&#xD;
&#xD;
          -  Immunosuppressive patients.&#xD;
&#xD;
          -  Patients taken cortisone.&#xD;
&#xD;
          -  Patients taken other drugs that prolong QT interval.&#xD;
&#xD;
          -  Patients taken drugs that need gastric acid for optimal absorption; ketoconazole, iron&#xD;
             salts, digoxin, ampicillin esters, anticoagulants, antineoplastic agents,&#xD;
             prostaglandin analogues, sukralfat.&#xD;
&#xD;
          -  Pregnancy or breast-feeding.&#xD;
&#xD;
          -  Patients taken drugs that may affect gastrointestinal system motility or acid release.&#xD;
&#xD;
          -  History of abdominal surgery (hysterectomy, abdominal hernia repair, caesarean cases&#xD;
             may be included; cholecystectomy have to be excluded).&#xD;
&#xD;
          -  Patients taken NSAII drugs (paracetemol may be used up to 2 gr/day).&#xD;
&#xD;
          -  Patients taken antidepressants.&#xD;
&#xD;
          -  Hypersensitivty to study drugs.&#xD;
&#xD;
          -  Known allergy to peanut and soy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ege University Facult of Medicine Gastroenterology Department</name>
      <address>
        <city>Izmir</city>
        <zip>35100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>January 27, 2017</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>December 11, 2018</last_update_submitted>
  <last_update_submitted_qc>December 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 12, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastroesophageal Reflux</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rabeprazole</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03037606
org study id: NEU-03.16
nct id: NCT03037606
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
It is planned to compare the efficacy and safety of rabeprazole 50 mg DDR (dual delayed
      release) capsules versus rabeprazole 20 mg enteric coated tablets administered once daily in
      patients with Gastroesophageal Reflux Disease (GERD).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Percentage time of 24-hour intragastric pH >4 compared to baseline
time frame: 7 days
measure: AUC of 24-hour intragastric pH >4 compared to baseline
time frame: 7 days
measure: Significant increase in total measurements of median pH
time frame: 7 days
measure: Significant increase in nocturnal measurements of median pH
time frame: 7 days
measure: Decrease in reflux symptom index calculated by weekly regurgitation numbers
time frame: 7 days
measure: Decrease in reflux symptom index calculated by weekly pyrosis numbers
time frame: 7 days
measure: Percentage time of 24-hour intragastric pH >2 compared to baseline
time frame: 7 days
measure: Percentage time of 24-hour intragastric pH >6 compared to baseline
time frame: 7 days
measure: AUC of 24-hour intragastric pH >2 compared to baseline
time frame: 7 days
measure: AUC of 24-hour intragastric pH >6 compared to baseline
time frame: 7 days
measure: Percentage time of 24-hour total intragastric pH >4 compared to baseline
time frame: 7 days
measure: AUC of 24-hour total intragastric pH >4 compared to baseline
time frame: 7 days
measure: Percentage time of 24-hour total intragastric pH >4 between 11 pm and 7 am compared to baseline baseline
time frame: 7 days
description: rate of night reflux
measure: AUC of of 24-hour total intragastric pH >4 between 11 pm and 7 am compared to baseline
time frame: 7 days
description: rate of night reflux
measure: The evaluation of safety of study drug (Number of Participants with Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatments)
time frame: 7 days
measure: Change in QT interval obtained by ECG compared to baseline
time frame: 21 days
arm group label: Rabelis DDR 50 mg Capsules and 1 placebo tablet
arm group type: Experimental
description: Placebo as comparator group is not used. Since study is double-blind, one placebo capsule and tablet is added to treatment groups in order to remove the discrepancy between investigational products.
arm group label: Pariet 20 mg Enteric Coated Tablets and 1 placebo capsule
arm group type: Active Comparator
description: Placebo as comparator group is not used. Since study is double-blind, one placebo capsule and tablet is added to treatment groups in order to remove the discrepancy between investigational products.
intervention type: Drug
intervention name: Rabelis DDR 50 mg Capsules
description: Rabelis DDR 50 mg Capsules once daily for seven days.
arm group label: Rabelis DDR 50 mg Capsules and 1 placebo tablet
intervention type: Drug
intervention name: Pariet 20 mg Enteric Coated Tablets
description: Pariet 20 mg Enteric Coated Tablets once daily for seven days.
arm group label: Pariet 20 mg Enteric Coated Tablets and 1 placebo capsule
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Turkey
responsible party type: Sponsor
mesh term: Gastroesophageal Reflux
mesh term: Rabeprazole
sharing ipd: Undecided