<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/NCT01710462</url>
  </required_header>
  <id_info>
    <org_study_id>EF129</org_study_id>
    <nct_id>NCT01710462</nct_id>
  </id_info>
  <brief_title>Clinical Study, Multicenter, Randomized With 2 Arms of Pantoprazole + Domperidone and Pantoprazole Isolated at the Gastroesophageal Reflux Disease</brief_title>
  <acronym>PANDA</acronym>
  <sponsors>
    <lead_sponsor>
      <agency>Eurofarma Laboratorios S.A.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eurofarma Laboratorios S.A.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This superiority phase III study to compare the combination of Pantoprazole and Domperidone&#xD;
      with Pantoprazole isolated to the treatment of gastroesophageal reflux disease. The&#xD;
      hypothesis is that combination of the two medication at the unique capsule is better to the&#xD;
      patients because decrease the quantity of times the patients need to take medicines during&#xD;
      the day.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Change of company's strategy&#xD;
  </why_stopped>
  <start_date>August 2013</start_date>
  <phase>Phase 3</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 (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate the efficacy of pantoprazole + domperidone Eurofarma at the treatment of gastroesophageal reflux disease in relation to the reference drug during 56 days using the score of symptoms</measure>
    <time_frame>Evaluation at the gastroesophageal reflux disease in 56 treatment days</time_frame>
    <description>The primary objective of the study is to evaluate the efficacy of combining incremental pantoprazole and domperidone Eurofarma the treatment of gastroesophageal reflux disease in relation to the reference drug. The primary endpoint is the score of symptoms (heartburn and regurgitation) including the severity and frequency after treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life during the study treatment</measure>
    <time_frame>Evaluation at the gastroesophageal reflux disease in 56 treatment days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Endoscopic cure rate for patients with erosive gastroesophageal reflux disease</measure>
    <time_frame>Evaluation at the gastroesophageal reflux disease in 56 treatment days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of adverse events observed</measure>
    <time_frame>Evaluation at the gastroesophageal reflux disease in 56 treatment days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Gastroesophageal Reflux Disease</condition>
  <arm_group>
    <arm_group_label>Pantoprazole + Domperidone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The combination of pantoprazole and domperidone provided for the study will be the new incremental formulation produced by Eurofarma. For this study will be used doses of capsules containing 20 mg pantoprazole, 20 mg of domperidone.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pantozol® (Takeda)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The Pantozol® may be presented in boxes of coated tablets of 20 mg or 40 mg. For this study will be used 20 mg tablets.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pantoprazole + Domperidone</intervention_name>
    <arm_group_label>Pantoprazole + Domperidone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pantozol®</intervention_name>
    <arm_group_label>Pantozol® (Takeda)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subscription of IC;&#xD;
&#xD;
          2. Age ≥ 18 years and &lt;70 years&#xD;
&#xD;
          3. Diagnosis initial clinical or previous symptomatic GERD;&#xD;
&#xD;
          4. Symptom score ≥ 4;&#xD;
&#xD;
          5. Ability to conduct examinations of endoscopy;&#xD;
&#xD;
          6. Ability to perform washout of drug classes PPIs, H2 antagonists, and prokinetics for&#xD;
             at least 14 days.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Presence of esophagitis requiring intervention, esophageal varices, Barrett's&#xD;
             esophagus, scleroderma, ulcers (gastric or duodenal), atrophic gastritis, or vagotomy&#xD;
             pangastritis detected at the time of study enrollment;&#xD;
&#xD;
          2. Eradication treatment of H. pylori completed less than 15 days of V0;&#xD;
&#xD;
          3. Presence of alarm symptoms (weight loss greater than 5% in the last 60 days, no&#xD;
             evidence of gastrointestinal bleeding);&#xD;
&#xD;
          4. Gastric or esophageal surgery prior (except for simple ulcer closure);&#xD;
&#xD;
          5. Females in pregnancy, lactation, or who wish to become pregnant if they refuse to use&#xD;
             adequate contraception during the study period.&#xD;
&#xD;
          6. Concomitant serious diseases such as kidney failure, heart and liver;&#xD;
&#xD;
          7. Suspected or confirmed any cancer except carcinoma in situ or nonmelanoma skin cancer&#xD;
             diagnosed in the last 5 years;&#xD;
&#xD;
          8. History of gastric cancer in relatives of 1st degree;&#xD;
&#xD;
          9. Use of illicit drugs or alcohol abuse according to the investigator;&#xD;
&#xD;
         10. Values changed (outside the normal range for the local laboratory) in leukocytes,&#xD;
             platelets or hemoglobin;&#xD;
&#xD;
         11. Significant changes in serum sodium, potassium, calcium or creatinine;&#xD;
&#xD;
         12. Intolerance or allergy to any component of the drugs evaluated in the study;&#xD;
&#xD;
         13. Use of anti-inflammatory drugs (NSAIDs), antiemetics, macrolides and systemic steroids&#xD;
             for a period of not less than 2 weeks prior to the study or who have expected&#xD;
             necessity of prolonged use during the study treatment;&#xD;
&#xD;
         14. Current use of bisphosphonates, as well as those who need calcium channel blockers or&#xD;
             other drugs that affect esophageal motility or lower esophageal sphincter tone.&#xD;
&#xD;
         15. Use of other scheduled medications metabolized by cytochrome CYP3A4 during the study;&#xD;
&#xD;
         16. Participation recent (past 12 months) or participation in a clinical trial expected&#xD;
             during this study in other clinical trials involving drugs of any kind.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Goiania</name>
      <address>
        <city>Goiania</city>
        <state>Goias</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Belo Horizonte</name>
      <address>
        <city>Belo Horizonte</city>
        <state>Minas Gerais</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Curitiba</name>
      <address>
        <city>Curitiba</city>
        <state>Paraná</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Porto Alegre</name>
      <address>
        <city>Porto Alegre</city>
        <state>Rio Grande do Sul</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Campinas</name>
      <address>
        <city>Campinas</city>
        <state>São Paulo</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jaú</name>
      <address>
        <city>Jaú</city>
        <state>São Paulo</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>São José do Rio Preto</name>
      <address>
        <city>São José do Rio Preto</city>
        <state>São Paulo</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rio de Janeiro</name>
      <address>
        <city>Rio de Janeiro</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 15, 2012</study_first_submitted>
  <study_first_submitted_qc>October 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 19, 2012</study_first_posted>
  <last_update_submitted>July 23, 2015</last_update_submitted>
  <last_update_submitted_qc>July 23, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 24, 2015</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>
    <mesh_term>Esophagitis, Peptic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Domperidone</mesh_term>
    <mesh_term>Pantoprazole</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/NCT01710462
org study id: EF129
nct id: NCT01710462
lead sponsor: 
has dmc: No
This superiority phase III study to compare the combination of Pantoprazole and Domperidone
      with Pantoprazole isolated to the treatment of gastroesophageal reflux disease. The
      hypothesis is that combination of the two medication at the unique capsule is better to the
      patients because decrease the quantity of times the patients need to take medicines during
      the day.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Evaluate the efficacy of pantoprazole + domperidone Eurofarma at the treatment of gastroesophageal reflux disease in relation to the reference drug during 56 days using the score of symptoms
time frame: Evaluation at the gastroesophageal reflux disease in 56 treatment days
description: The primary objective of the study is to evaluate the efficacy of combining incremental pantoprazole and domperidone Eurofarma the treatment of gastroesophageal reflux disease in relation to the reference drug. The primary endpoint is the score of symptoms (heartburn and regurgitation) including the severity and frequency after treatment
measure: Quality of life during the study treatment
time frame: Evaluation at the gastroesophageal reflux disease in 56 treatment days
measure: Endoscopic cure rate for patients with erosive gastroesophageal reflux disease
time frame: Evaluation at the gastroesophageal reflux disease in 56 treatment days
measure: Frequency of adverse events observed
time frame: Evaluation at the gastroesophageal reflux disease in 56 treatment days
arm group label: Pantoprazole + Domperidone
arm group type: Experimental
description: The combination of pantoprazole and domperidone provided for the study will be the new incremental formulation produced by Eurofarma. For this study will be used doses of capsules containing 20 mg pantoprazole, 20 mg of domperidone.
arm group label: Pantozol® (Takeda)
arm group type: Active Comparator
description: The Pantozol® may be presented in boxes of coated tablets of 20 mg or 40 mg. For this study will be used 20 mg tablets.
intervention type: Drug
intervention name: Pantoprazole + Domperidone
arm group label: Pantoprazole + Domperidone
intervention type: Drug
intervention name: Pantozol®
arm group label: Pantozol® (Takeda)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Brazil
responsible party type: Sponsor
mesh term: Gastroesophageal Reflux
mesh term: Esophagitis, Peptic
mesh term: Domperidone
mesh term: Pantoprazole