<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/NCT04400201</url>
  </required_header>
  <id_info>
    <org_study_id>HR-RMZL-Ⅲ-FB</org_study_id>
    <nct_id>NCT04400201</nct_id>
  </id_info>
  <brief_title>A Clinical Study of Remimazolam Tosilate in Patients Undergoing Bronchoscopy</brief_title>
  <official_title>A Phase III Clinical Study Evaluating the Efficacy and Safety of Remimazolam Tosilate Compared to Propofol in Patients Undergoing Bronchoscopy</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A multicenter, randomized, single-blind, active controlled, parallel group study comparing&#xD;
      remimazolam tosilate to propofol in patients undergoing bronchoscopy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 15, 2020</start_date>
  <completion_date type="Actual">October 30, 2020</completion_date>
  <primary_completion_date type="Actual">October 28, 2020</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage (%) of participants who experienced successful sedation in undergoing bronchoscopy in each group</measure>
    <time_frame>From the onset of administration of the study drug to removal of bronchoscope on Day 1 of treatment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time from start of investigational medicinal product administration to loss of consciousness</measure>
    <time_frame>From the onset of administration of the study drug to unconsciousness on Day 1 of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time from stop of investigational medicinal product to MOAA/S Score=5</measure>
    <time_frame>From the last dose of study drug until the patient has recovered to fully alert on Day 1 of treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time from stop of investigational medicinal product to Aldrete Score≥9</measure>
    <time_frame>From the end of administration of the study drug until the patient reaches the modified Aldrete's system score of ≥9 points on Day 1 of treatment</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">330</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>Intravenous injection at a dose of 0.3mg/kg for sedation induction and continuous intravenous infusion at an initiative dose of 1 mg/kg/h for sedation maintenance.</description>
    <arm_group_label>Remimazolam Tosilate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Propofol</intervention_name>
    <description>Intravenous injection at a dose of 1.5~2.5mg/kg for sedation induction and continuous intravenous infusion at the dose of 0~12 mg/kg/h for sedation maintenance</description>
    <arm_group_label>Propofol</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 18~80 years, female or male&#xD;
&#xD;
          2. Patients scheduled for an bronchoscopy procedure&#xD;
&#xD;
          3. 18 kg/m2&lt;BMI&lt;30kg/m2&#xD;
&#xD;
          4. Patients understand clearly and participate in the study voluntarily, and sign the&#xD;
             informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients scheduled for emergency surgery&#xD;
&#xD;
          2. Patients with a history of drug abuse and / or alcohol abuse 2 years prior to the&#xD;
             screening period&#xD;
&#xD;
          3. One or more of the laboratory findings fall out of the limitations for this&#xD;
             study(platelet,hemoglobin,aspartate aminotransferase,etc.);&#xD;
&#xD;
          4. Pregnant women or those in lactation period&#xD;
&#xD;
          5. Allergic to drugs used in the study&#xD;
&#xD;
          6. Patients have participated in other clinical trial within the 3 months prior to&#xD;
             randomization&#xD;
&#xD;
          7. Any patient judged by the Principal Investigator (PI) or Sub-Investigator to be&#xD;
             inappropriate for the subject for any other 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>
  <overall_official>
    <last_name>Peking Union Medical College Hospital</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking Union Medical College Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 14, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 22, 2020</study_first_posted>
  <last_update_submitted>August 19, 2022</last_update_submitted>
  <last_update_submitted_qc>August 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2022</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/NCT04400201
org study id: HR-RMZL-Ⅲ-FB
nct id: NCT04400201
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
A multicenter, randomized, single-blind, active controlled, parallel group study comparing
      remimazolam tosilate to propofol in patients undergoing bronchoscopy.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Percentage (%) of participants who experienced successful sedation in undergoing bronchoscopy in each group
time frame: From the onset of administration of the study drug to removal of bronchoscope on Day 1 of treatment
measure: Time from start of investigational medicinal product administration to loss of consciousness
time frame: From the onset of administration of the study drug to unconsciousness on Day 1 of treatment
measure: Time from stop of investigational medicinal product to MOAA/S Score=5
time frame: From the last dose of study drug until the patient has recovered to fully alert on Day 1 of treatment
measure: Time from stop of investigational medicinal product to Aldrete Score≥9
time frame: From the end of administration of the study drug until the patient reaches the modified Aldrete's system score of ≥9 points on Day 1 of treatment
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: Intravenous injection at a dose of 0.3mg/kg for sedation induction and continuous intravenous infusion at an initiative dose of 1 mg/kg/h for sedation maintenance.
arm group label: Remimazolam Tosilate
intervention type: Drug
intervention name: Propofol
description: Intravenous injection at a dose of 1.5~2.5mg/kg for sedation induction and continuous intravenous infusion at the dose of 0~12 mg/kg/h for sedation maintenance
arm group label: Propofol
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Peking Union Medical College Hospital
role: Principal Investigator
affiliation: Peking Union Medical College Hospital
facility: 
country: China
responsible party type: Sponsor
mesh term: Propofol