<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/NCT02967094</url>
  </required_header>
  <id_info>
    <org_study_id>DDC VN 09</org_study_id>
    <nct_id>NCT02967094</nct_id>
  </id_info>
  <brief_title>Mucolytic Solution Before Upper Endoscopy</brief_title>
  <official_title>The Use of Mucolytic Solution Before Upper Endoscopy: A Randomized, Double-blinded Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vitkovice Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vitkovice Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study was designed to evaluate efficacy of mucolytic solution ingested before upper endoscopy&#xD;
      on visibility of gastric mucosa.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Residual gastric content containing mucus, bubbles, bile and food particles may limit&#xD;
      visibility of gastric mucosa and therefore diagnostic yield of upper endoscopy, especially in&#xD;
      cases of early neoplastic lesions. Data on benefit of peroral mucolytic solution administered&#xD;
      before upper endoscopy are limited.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">May 2017</completion_date>
  <primary_completion_date type="Anticipated">March 2017</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>Diagnostic</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>&quot;Visibility score&quot; evaluated by blinded performing endoscopist</measure>
    <time_frame>through study completion, an average of 3 months</time_frame>
    <description>&quot;Visibility score&quot; (0-25 points) counted as the sum of visibility score in the esophagus (0-5), fundus (0-5), corpus (0-5) and atrum (0-5) of the stomach and in the duodenum (0-5).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>&quot;Visibility score&quot; evaluated by three blinded endoscopists using 11 endoscopic images captured during endoscopy.</measure>
    <time_frame>through study completion, an average of 3 months</time_frame>
    <description>&quot;Visibility score&quot; (0-25 points) counted as the sum of visibility score in the esophagus (0-5), fundus (0-5), corpus (0-5) and atrum (0-5) of the stomach and in the duodenum (0-5).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Residual fluid in the stomach evaluated by blinded performing endoscopist</measure>
    <time_frame>through study completion, an average of 3 months</time_frame>
    <description>0-3 point scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of endoscopy</measure>
    <time_frame>through study completion, an average of 3 months</time_frame>
    <description>time between introduction and withdrawal of the endoscopy</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Gastroscopy; Gastric Cancer</condition>
  <arm_group>
    <arm_group_label>A - mucolytic solution</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mucolytic solution consisting of 100 ml of water, 100 mg of simethicon and 400 mg of N-acetylcystein administered 30 minutes prior to upper endoscopy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B - no intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Upper endoscopy without neither mucolytic solution nor water prior to upper endoscopy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>C - water</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>100 ml of water given 30 minutes prior to upper endoscopy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Administration of mucolytic solution before upper endoscopy (Espumisan, ACC long)</intervention_name>
    <arm_group_label>A - mucolytic solution</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Administration of water before upper endoscopy</intervention_name>
    <arm_group_label>C - water</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age &gt; 18 years&#xD;
&#xD;
          -  signed informed consent&#xD;
&#xD;
          -  diagnostic gastroscopy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age &lt; 18 years&#xD;
&#xD;
          -  interventional gastroscopy&#xD;
&#xD;
          -  known disease of the upper GI tract and/or history of surgery of GI tract&#xD;
&#xD;
          -  gastroscopy indicated of bleeding, dysphagia or ileus&#xD;
&#xD;
          -  liver cirrhosis&#xD;
&#xD;
          -  general anesthesia&#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_official>
    <last_name>Premysl Falt, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Digestive Diseases Center, Vítkovice Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Premysl Falt, M.D., Ph.D.</last_name>
    <phone>+420595633</phone>
    <phone_ext>205</phone_ext>
    <email>faltprem@centrum.cz</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Barbora Pipek, M.D.</last_name>
    <phone>+420595633</phone>
    <phone_ext>205</phone_ext>
    <email>barbora.pipek@seznam.cz</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Digestive Diseases Center</name>
      <address>
        <city>Ostrava</city>
        <zip>70384</zip>
        <country>Czech Republic</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Premysl Falt, M.D., Ph.D.</last_name>
      <phone>+420602689561</phone>
      <email>faltprem@centrum.cz</email>
    </contact>
  </location>
  <location_countries>
    <country>Czech Republic</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 10, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 17, 2016</study_first_posted>
  <last_update_submitted>November 27, 2016</last_update_submitted>
  <last_update_submitted_qc>November 27, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vitkovice Hospital</investigator_affiliation>
    <investigator_full_name>Premysl Falt, M.D., Ph.D.</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stomach Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Expectorants</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT02967094
org study id: DDC VN 09
nct id: NCT02967094
lead sponsor: 
has dmc: No
Study was designed to evaluate efficacy of mucolytic solution ingested before upper endoscopy
      on visibility of gastric mucosa.
Residual gastric content containing mucus, bubbles, bile and food particles may limit
      visibility of gastric mucosa and therefore diagnostic yield of upper endoscopy, especially in
      cases of early neoplastic lesions. Data on benefit of peroral mucolytic solution administered
      before upper endoscopy are limited.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: "Visibility score" evaluated by blinded performing endoscopist
time frame: through study completion, an average of 3 months
description: "Visibility score" (0-25 points) counted as the sum of visibility score in the esophagus (0-5), fundus (0-5), corpus (0-5) and atrum (0-5) of the stomach and in the duodenum (0-5).
measure: "Visibility score" evaluated by three blinded endoscopists using 11 endoscopic images captured during endoscopy.
time frame: through study completion, an average of 3 months
description: "Visibility score" (0-25 points) counted as the sum of visibility score in the esophagus (0-5), fundus (0-5), corpus (0-5) and atrum (0-5) of the stomach and in the duodenum (0-5).
measure: Residual fluid in the stomach evaluated by blinded performing endoscopist
time frame: through study completion, an average of 3 months
description: 0-3 point scale
measure: Duration of endoscopy
time frame: through study completion, an average of 3 months
description: time between introduction and withdrawal of the endoscopy
arm group label: A - mucolytic solution
arm group type: Experimental
description: Mucolytic solution consisting of 100 ml of water, 100 mg of simethicon and 400 mg of N-acetylcystein administered 30 minutes prior to upper endoscopy.
arm group label: B - no intervention
arm group type: No Intervention
description: Upper endoscopy without neither mucolytic solution nor water prior to upper endoscopy.
arm group label: C - water
arm group type: Placebo Comparator
description: 100 ml of water given 30 minutes prior to upper endoscopy.
intervention type: Drug
intervention name: Administration of mucolytic solution before upper endoscopy (Espumisan, ACC long)
arm group label: A - mucolytic solution
intervention type: Drug
intervention name: Administration of water before upper endoscopy
arm group label: C - water
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Premysl Falt, M.D., Ph.D.
role: Principal Investigator
affiliation: Digestive Diseases Center, Vítkovice Hospital
last name: Premysl Falt, M.D., Ph.D.
phone: +420595633
phone ext: 205
email: faltprem@centrum.cz
last name: Barbora Pipek, M.D.
phone: +420595633
phone ext: 205
email: barbora.pipek@seznam.cz
facility: 
status: Recruiting
contact: 
country: Czech Republic
responsible party type: Principal Investigator
investigator affiliation: Vitkovice Hospital
investigator full name: Premysl Falt, M.D., Ph.D.
investigator title: Principle Investigator
mesh term: Stomach Neoplasms
mesh term: Expectorants
sharing ipd: No