<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/NCT03779061</url>
  </required_header>
  <id_info>
    <org_study_id>HR-RMZL-Ⅲ-PEC</org_study_id>
    <nct_id>NCT03779061</nct_id>
  </id_info>
  <brief_title>Study of Remimazolam Tosilate in Patients Undergoing Colonoscopy</brief_title>
  <official_title>A Phase Ⅲ, Multicentre, Randomized, Single-blinded Study to Evaluate the Safety and Efficacy of the Sedation for Remimazolam or Propofol in Patients Undergoing Colonoscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jiangsu HengRui Medicine Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jiangsu HengRui Medicine Co., Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The purpose of this study is to evaluate the safety and efficacy of the sedation for&#xD;
      Remimazolam or Propofol in patients undergoing colonoscopy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multi-center, parallel-group, single blind study using Remimazolam or propofol for&#xD;
      sedation in patients undergoing colonoscopy.Subjects are randomized to different treatment&#xD;
      groups (including 1 for Remimazolam Tosilate and 1 for propofol). Fentanyl are permitted&#xD;
      before colonoscopy. Efficacy and safety profiles of Remimazolam Tosilate are to be evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 28, 2018</start_date>
  <completion_date type="Actual">September 28, 2018</completion_date>
  <primary_completion_date type="Actual">September 20, 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>Other</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>Single (Participant)</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>rate of successful sedation</measure>
    <time_frame>approximately 3 hours</time_frame>
    <description>successful sedation rate as measured by the proportion of subjects who experienced successful sedation during colonoscopy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sedation induction time</measure>
    <time_frame>approximately 3 hours</time_frame>
    <description>Sedation induction time is defined as from start of study drug injection to the first time of MOAA/S（The Observer's Assessment of Alertness/Sedation Scale） ≤ 3.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sedation recovery time</measure>
    <time_frame>approximately 3 hours</time_frame>
    <description>Sedation induction time is defined as from stop of study drug injection to be wide awake.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>rate of hypotension</measure>
    <time_frame>approximately 3 hours</time_frame>
    <description>rate of hypotension as measured by the proportion of subjects who experienced hypotension</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>rate of respiratory depression</measure>
    <time_frame>approximately 3 hours</time_frame>
    <description>rate of respiratory depression as measured by the proportion of subjects who experienced respiratory depression</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">388</enrollment>
  <condition>Sedation</condition>
  <arm_group>
    <arm_group_label>Remimazolam Tosilate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Propofol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Remimazolam Tosilate</intervention_name>
    <description>Initial dose plus supplemental doses as necessary</description>
    <arm_group_label>Remimazolam Tosilate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Propofol</intervention_name>
    <description>Initial dose plus supplemental doses as necessary</description>
    <arm_group_label>Propofol</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  subjects aged 18-65 years；&#xD;
&#xD;
          -  intending to undergo colonoscopy;&#xD;
&#xD;
          -  ASA( American Society of Anesthesiologists) I or II；&#xD;
&#xD;
          -  18 kg/m²&lt;BMI(Body Mass Index)&lt;30 kg/m²;&#xD;
&#xD;
          -  the operation time of gastroscopy is not more than 30 min；&#xD;
&#xD;
          -  Signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients need to be Complicated colonoscopy;&#xD;
&#xD;
          -  Patients need to be Tracheal intubation;&#xD;
&#xD;
          -  Patients with respiratory management difficulties (Modified Mallampati grade IV）;&#xD;
&#xD;
          -  one or more of the laboratory findings fall out of the limitations for this&#xD;
             study(platelet,hemoglobin,aspartate aminotransferase,etc.);&#xD;
&#xD;
          -  A history of drug abuse and / or alcohol abuse 2 years prior to the screening period；&#xD;
&#xD;
          -  allergic to drugs used in the study;&#xD;
&#xD;
          -  pregnant women or those in lactation period&#xD;
&#xD;
          -  The subject has participated in other clinical trial within the 3 months prior to&#xD;
             randomization.&#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>Clinical trial Ethnics Committee of Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>010</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>December 16, 2018</study_first_submitted>
  <study_first_submitted_qc>December 16, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>December 16, 2018</last_update_submitted>
  <last_update_submitted_qc>December 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Propofol</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/NCT03779061
org study id: HR-RMZL-Ⅲ-PEC
nct id: NCT03779061
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the safety and efficacy of the sedation for
      Remimazolam or Propofol in patients undergoing colonoscopy.
This is a multi-center, parallel-group, single blind study using Remimazolam or propofol for
      sedation in patients undergoing colonoscopy.Subjects are randomized to different treatment
      groups (including 1 for Remimazolam Tosilate and 1 for propofol). Fentanyl are permitted
      before colonoscopy. Efficacy and safety profiles of Remimazolam Tosilate are to be evaluated.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Double (Participant, Outcomes Assessor)
masking description: Single (Participant)
measure: rate of successful sedation
time frame: approximately 3 hours
description: successful sedation rate as measured by the proportion of subjects who experienced successful sedation during colonoscopy
measure: Sedation induction time
time frame: approximately 3 hours
description: Sedation induction time is defined as from start of study drug injection to the first time of MOAA/S（The Observer's Assessment of Alertness/Sedation Scale） ≤ 3.
measure: Sedation recovery time
time frame: approximately 3 hours
description: Sedation induction time is defined as from stop of study drug injection to be wide awake.
measure: rate of hypotension
time frame: approximately 3 hours
description: rate of hypotension as measured by the proportion of subjects who experienced hypotension
measure: rate of respiratory depression
time frame: approximately 3 hours
description: rate of respiratory depression as measured by the proportion of subjects who experienced respiratory depression
arm group label: Remimazolam Tosilate
arm group type: Experimental
arm group label: Propofol
arm group type: Active Comparator
intervention type: Drug
intervention name: Remimazolam Tosilate
description: Initial dose plus supplemental doses as necessary
arm group label: Remimazolam Tosilate
intervention type: Drug
intervention name: Propofol
description: Initial dose plus supplemental doses as necessary
arm group label: Propofol
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor
mesh term: Propofol