<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/NCT03263910</url>
  </required_header>
  <id_info>
    <org_study_id>NPO-11_301</org_study_id>
    <nct_id>NCT03263910</nct_id>
  </id_info>
  <brief_title>Study of NPO-11 in Patients Undergoing Gastrointestinal Endoscopy</brief_title>
  <official_title>Phase Ⅲ Placebo-controlled Study of NPO-11 in Chinese Patients Undergoing Gastrointestinal Endoscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nihon Pharmaceutical Co., Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nihon Pharmaceutical Co., Ltd</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>
      Chinese patients who require gastrointestinal endoscopy will receive an intra-gastric single&#xD;
      dose of NPO-11 20ml. The superiority of NPO-11 compared to placebo as a premedication for&#xD;
      endoscopy will be verified in a randomized, double-blind, parallel-assignment design based on&#xD;
      the proportion of patients having no gastric peristalsis.&#xD;
&#xD;
      The safety of NPO-11 will be evaluated based on adverse events and adverse drug reactions&#xD;
      observed between informed consent and 7 days after administration in comparison with the&#xD;
      placebo group.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 21, 2017</start_date>
  <completion_date type="Actual">August 17, 2018</completion_date>
  <primary_completion_date type="Actual">August 10, 2018</primary_completion_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>Diagnostic</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The proportion of patients had no gastric peristalsis during the procedures</measure>
    <time_frame>15 minutes</time_frame>
    <description>No gastric peristalsis is defined as when patients have no gastric peristalsis at both 2 minutes post-dose and the end of endoscopy.(central evaluation by independent evaluator)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in peristaltic movement</measure>
    <time_frame>15 minutes</time_frame>
    <description>The measure use peristaltic grade(central evaluation by independent evaluator).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difficulty level of intra-gastric observation</measure>
    <time_frame>15 minutes</time_frame>
    <description>Subjective evaluation by investigator or subinvestigator who performs endoscopy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between the time from the dose to the end of endoscopy and peristaltic grade</measure>
    <time_frame>15 minutes</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">220</enrollment>
  <condition>Patients Undergoing Gastrointestinal Endoscopy</condition>
  <arm_group>
    <arm_group_label>NPO-11</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NPO-11</intervention_name>
    <description>20 ml NPO-11</description>
    <arm_group_label>NPO-11</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>20 ml NPO-11(Placebo)</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients who are capable of understanding and complying with protocol requirements in&#xD;
             the opinion of the investigator or the sub-investigator.&#xD;
&#xD;
          2. Patients who are able to fill in the informed consent form.&#xD;
&#xD;
          3. Patients who require gastrointestinal endoscopy using a scope of 9mm or greater&#xD;
             diameter for follow-up of confirmed or investigation of a suspected upper&#xD;
             gastrointestinal disease. (except for transnasal endoscopy and emergency endoscopy)&#xD;
&#xD;
          4. Male or female chinese patients aged _18_ to _80&#xD;
&#xD;
          5. Patients who agree to use routinely adequate contraception from signing of informed&#xD;
             consent to follow-up.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients have received any investigational drug of other study within 120 days prior&#xD;
             to providing their informed consent.&#xD;
&#xD;
          2. Patients had been administered NPO-11 in the past.&#xD;
&#xD;
          3. Patients who are the study site investigator or sub-investigator, an immediate family&#xD;
             member (eg, spouse,parent, child, sibling), or may consent under duress.&#xD;
&#xD;
          4. Patients have a history of upper gastrointestinal tract surgery.&#xD;
&#xD;
          5. Patients have gastric stenosis or deformity that would make observation of peristaltic&#xD;
             movement difficult.&#xD;
&#xD;
          6. Patients have bleeding in the upper gastrointestinal tract and require hemostatic&#xD;
             intervention.&#xD;
&#xD;
          7. Patients have reflux esophagitis (defined as Los Angeles Class: B, C or D)&#xD;
&#xD;
          8. Patients have an active gastric or duodenal ulcer (defined as Sakita-Miwa class: A1 or&#xD;
             A2)&#xD;
&#xD;
          9. Patients are on treatment (radiotherapy or chemotherapy) for cancer.&#xD;
&#xD;
         10. Patient have decreased heart function (NYHA heart function class: III or more)&#xD;
&#xD;
         11. Patients have a history of shock, hypersensitivity or allergies to l-menthol or&#xD;
             peppermint oil.&#xD;
&#xD;
         12. Patients have a history of drug abuse (defined as any illicit drug use) or a history&#xD;
             of alcohol abuse within 12 months prior to the screening visit.&#xD;
&#xD;
         13. Patients are required to take excluded medications.&#xD;
&#xD;
         14. If female, patients are pregnant or lactating or intending to become pregnant from&#xD;
             signing of informed consent to follow-up.&#xD;
&#xD;
         15. Any subject who, in the opinion of the investigator or the sub-investigator, is unable&#xD;
             to comply with the requirements of the study or is unsuitable for any reason.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>East China</name>
      <address>
        <city>East China</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>North China</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Northwest China</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>South China</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 28, 2017</study_first_posted>
  <last_update_submitted>August 21, 2018</last_update_submitted>
  <last_update_submitted_qc>August 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 23, 2018</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/NCT03263910
org study id: NPO-11_301
nct id: NCT03263910
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Chinese patients who require gastrointestinal endoscopy will receive an intra-gastric single
      dose of NPO-11 20ml. The superiority of NPO-11 compared to placebo as a premedication for
      endoscopy will be verified in a randomized, double-blind, parallel-assignment design based on
      the proportion of patients having no gastric peristalsis.

      The safety of NPO-11 will be evaluated based on adverse events and adverse drug reactions
      observed between informed consent and 7 days after administration in comparison with the
      placebo group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The proportion of patients had no gastric peristalsis during the procedures
time frame: 15 minutes
description: No gastric peristalsis is defined as when patients have no gastric peristalsis at both 2 minutes post-dose and the end of endoscopy.(central evaluation by independent evaluator)
measure: Change in peristaltic movement
time frame: 15 minutes
description: The measure use peristaltic grade(central evaluation by independent evaluator).
measure: Difficulty level of intra-gastric observation
time frame: 15 minutes
description: Subjective evaluation by investigator or subinvestigator who performs endoscopy
measure: Correlation between the time from the dose to the end of endoscopy and peristaltic grade
time frame: 15 minutes
arm group label: NPO-11
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: NPO-11
description: 20 ml NPO-11
arm group label: NPO-11
intervention type: Drug
intervention name: Placebo
description: 20 ml NPO-11(Placebo)
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
country: China
responsible party type: Sponsor