<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/NCT02210494</url>
  </required_header>
  <id_info>
    <org_study_id>EP202</org_study_id>
    <nct_id>NCT02210494</nct_id>
  </id_info>
  <brief_title>Safety of Secretrol® in the Short-term Management of Patients Undergoing Endoscopic Mucosal Resection (EMR)</brief_title>
  <official_title>Phase 1 Study of Safety of Secretrol® in the Short-term Management of Patients Undergoing Endoscopic Mucosal Resection (EMR)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Effexus Pharmaceutical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Effexus Pharmaceutical</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluate the safety of Secretrol® in patients undergoing endoscopic mucosal resection for&#xD;
      early adenocarcinoma of the esophagus.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>April 2013</start_date>
  <primary_completion_date type="Anticipated">August 2015</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse effect evaluation</measure>
    <time_frame>60 days</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">5</enrollment>
  <condition>EMR Ulcer</condition>
  <arm_group>
    <arm_group_label>Secretrol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Secretrol</intervention_name>
    <arm_group_label>Secretrol</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Category 4-high-grade intraepithelial neoplasia&#xD;
&#xD;
          -  Ages 18 or older&#xD;
&#xD;
          -  signed Informed Consent Form&#xD;
&#xD;
          -  signed Health Insurance Portability and Accountability Act (HIPAA) Authorization Form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinically relevant data suggesting an unknown disease and requiring further&#xD;
             evaluation by the Primary Investigator.&#xD;
&#xD;
          -  Patients with renal failure or organ transplants.&#xD;
&#xD;
          -  Patients who have known allergic reactions to Proton Pump Inhibitors (PPI).&#xD;
&#xD;
          -  Participation in another study that would interfere with study endpoints within 30&#xD;
             days prior to screening.&#xD;
&#xD;
          -  Previous enrollment into the current study.&#xD;
&#xD;
          -  Patient is the Investigator, his family member or employee at the investigational&#xD;
             site.&#xD;
&#xD;
          -  Patient known or suspected to be involved in alcohol or drug abuse.&#xD;
&#xD;
          -  Known or suspected history of non-compliance with medications.&#xD;
&#xD;
          -  Inability to follow the procedures of the study (e.g., due to language problems,&#xD;
             psychological disorders)&#xD;
&#xD;
          -  Patients receiving prohibited concomitant medications including PPIs, H2-blockers,&#xD;
             sucralfate, misoprostol.&#xD;
&#xD;
          -  Patients receiving prohibited concomitant medications including clopidogrel,&#xD;
             ketoconazole, digoxin, diazepam, warfarin, phenytoin,&#xD;
             emtricitabine/nelfinavir/tenofovir, atazanavir, citalopram,&#xD;
             emtricitabine/rilpivirine/tenofovir, rilpivirine, nelfinavir, tricyclic&#xD;
             antidepressants, baclofen, tacrolimus, cyclosporine, cilostazol, disulfiram,&#xD;
             methotrexate, voriconazole.&#xD;
&#xD;
          -  Pregnancy or intention to become pregnant during the course of study, breast feeding,&#xD;
             or unwillingness to use a highly effective means of contraception (oral contraception&#xD;
             or intrauterine device).&#xD;
&#xD;
          -  Prescription Non-steroidal anti-inflammatory Drug (NSAID) or aspirin use: The patient&#xD;
             must be able to stop these meds 1 week prior to screening and during treatment.&#xD;
&#xD;
          -  History of upper gastrointestinal surgery, Zollinger-Ellison syndrome, esophageal&#xD;
             stricture, peptic stricture, duodenal and ⁄ or gastric ulcer, esophageal motility&#xD;
             disorders, Inflammatory Bowel Disease (IBD), AIDS, pancreatitis, malabsorption, severe&#xD;
             cardiovascular or pulmonary disease, liver disease, active malignant disease,&#xD;
             Scleroderma, diabetes mellitus, autonomic or peripheral neuropathy, myopathy,&#xD;
             functional bowel disorder or any underlying disease or medication that might affect&#xD;
             the lower esophageal sphincter pressure or increase the acid clearance time.&#xD;
&#xD;
          -  Subject unable or unwilling to fully complete all stages of the study.&#xD;
&#xD;
          -  Unable to sign informed consent or inability to give fully informed consent due to&#xD;
             language problems, psychological disorder or mental deficiency.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>April Higbee, BSN</last_name>
    <phone>816 861-4700</phone>
    <phone_ext>57456</phone_ext>
    <email>April.Higbee@va.gov</email>
  </overall_contact>
  <location>
    <facility>
      <name>Veteran's Administration Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64128</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Higbee, BSN</last_name>
      <phone>816-861-4700</phone>
      <phone_ext>57456</phone_ext>
    </contact>
    <investigator>
      <last_name>Prateek Sharma, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 1, 2014</study_first_submitted>
  <study_first_submitted_qc>August 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 6, 2014</study_first_posted>
  <last_update_submitted>August 4, 2014</last_update_submitted>
  <last_update_submitted_qc>August 4, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 6, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02210494
org study id: EP202
nct id: NCT02210494
lead sponsor: 
has dmc: Yes
Evaluate the safety of Secretrol® in patients undergoing endoscopic mucosal resection for
      early adenocarcinoma of the esophagus.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Adverse effect evaluation
time frame: 60 days
arm group label: Secretrol
arm group type: Experimental
intervention type: Drug
intervention name: Secretrol
arm group label: Secretrol
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: April Higbee, BSN
phone: 816 861-4700
phone ext: 57456
email: April.Higbee@va.gov
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor