<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/NCT03003884</url>
  </required_header>
  <id_info>
    <org_study_id>HR-RMZL-IIc-UGE</org_study_id>
    <nct_id>NCT03003884</nct_id>
  </id_info>
  <brief_title>A Study of Remimazolam Tosilate in Patients Undergoing Diagnostic Upper GI Endoscopy</brief_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>
  <brief_summary>
    <textblock>
      The purpose of this study is to find out the optimal dose for Remimazolam Tosilate as a&#xD;
      procedural sedative during a diagnostic upper GI endoscopy and to assess its efficacy and&#xD;
      safety profile comparing to propofol.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an multi-center,single-blinded,parallel-group,dose-finding study using Remimazolam or&#xD;
      propofol for sedation in patients undergoing diagnostic upper GI endoscopy.Subjects are&#xD;
      randomized to different treatment groups (including 4 for Remimazolam Tosilate and 1 for&#xD;
      propofol).Lidocaine and fentanyl are permitted during a diagnostic upper GI&#xD;
      endoscopy.Efficacy and safety profiles of Remimazolam Tosilate are to be evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">March 2017</completion_date>
  <primary_completion_date type="Actual">March 2017</primary_completion_date>
  <phase>Phase 2</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>successful sedation rate as measured by the proportion of subjects who experienced successful sedation during diagnostic upper GI endoscopy.</measure>
    <time_frame>From start of study drug injection to patient discharge (approx. 3 hours)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>recovery time as measured by time</measure>
    <time_frame>After the last of study drug injection to patient discharge (approx. 3 hours)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>rate of hypotension as measured by the proportion of subjects who experienced hypotension during a diagnostic upper GI endoscopy</measure>
    <time_frame>From start of study drug injection to patient discharge (approx. 3 hours)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>rate of hypoxaemia as measured by the proportion of subjects who experienced hypoxaemia during a diagnostic upper GI endoscopy</measure>
    <time_frame>From start of study drug injection to patient discharge (approx. 3 hours)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>rate of respiratory depression as measured by the proportion of subjects who experienced respiratory depression during a diagnostic upper GI endoscopy</measure>
    <time_frame>From start of study drug injection to patient discharge (approx. 3 hours)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pain on injection was assessed by the patient immediately after administration of the study drug</measure>
    <time_frame>1-10 minutes (from the beginning of sedation )]</time_frame>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">153</enrollment>
  <condition>Sedation</condition>
  <arm_group>
    <arm_group_label>Remimazolam Tosilate 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>IV of Remimazolam Tosilate at 5mg for initial dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Remimazolam Tosilate 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>IV of Remimazolam Tosilate at 7mg for initial dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Remimazolam Tosilate 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>IV of Remimazolam Tosilate at 8mg for initial dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Remimazolam Tosilate 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>IV of Remimazolam Tosilate at 5mg for initial dose.At the end of the endoscopy, flumazenil was injected.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Propofol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>IV of Propofol at 1.5mg/kg for initial dose</description>
  </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 1</arm_group_label>
    <arm_group_label>Remimazolam Tosilate 2</arm_group_label>
    <arm_group_label>Remimazolam Tosilate 3</arm_group_label>
    <arm_group_label>Remimazolam Tosilate 4</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 18-60 years；&#xD;
&#xD;
          -  intending to undergo diagnostic upper GI endoscopy&#xD;
&#xD;
          -  American Society of Anesthesiologists Physical Status Score (ASA PS) I or II；&#xD;
&#xD;
          -  18 kg/m²&lt;BMI(Body Mass Index)&lt;30 kg/m².&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a suspected upper GI bleed an conditions predisposing to hemorrhage at&#xD;
             the discretion of the investigator;&#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;
          -  history of recent use of narcotics,analgesics,anaesthetics and benzodiazepine&#xD;
             hypnotics;&#xD;
&#xD;
          -  history of severe cardiovascular disease;&#xD;
&#xD;
          -  cerebral disease or mental disorder;&#xD;
&#xD;
          -  allergic to drugs used in the study;&#xD;
&#xD;
          -  pregnant women or those in lactation period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Beijing Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 22, 2016</study_first_submitted>
  <study_first_submitted_qc>December 27, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 28, 2016</study_first_posted>
  <last_update_submitted>September 6, 2017</last_update_submitted>
  <last_update_submitted_qc>September 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2017</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/NCT03003884
org study id: HR-RMZL-IIc-UGE
nct id: NCT03003884
lead sponsor: 
The purpose of this study is to find out the optimal dose for Remimazolam Tosilate as a
      procedural sedative during a diagnostic upper GI endoscopy and to assess its efficacy and
      safety profile comparing to propofol.
This is an multi-center,single-blinded,parallel-group,dose-finding study using Remimazolam or
      propofol for sedation in patients undergoing diagnostic upper GI endoscopy.Subjects are
      randomized to different treatment groups (including 4 for Remimazolam Tosilate and 1 for
      propofol).Lidocaine and fentanyl are permitted during a diagnostic upper GI
      endoscopy.Efficacy and safety profiles of Remimazolam Tosilate are to be evaluated.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Participant)
measure: successful sedation rate as measured by the proportion of subjects who experienced successful sedation during diagnostic upper GI endoscopy.
time frame: From start of study drug injection to patient discharge (approx. 3 hours)
measure: recovery time as measured by time
time frame: After the last of study drug injection to patient discharge (approx. 3 hours)
measure: rate of hypotension as measured by the proportion of subjects who experienced hypotension during a diagnostic upper GI endoscopy
time frame: From start of study drug injection to patient discharge (approx. 3 hours)
measure: rate of hypoxaemia as measured by the proportion of subjects who experienced hypoxaemia during a diagnostic upper GI endoscopy
time frame: From start of study drug injection to patient discharge (approx. 3 hours)
measure: rate of respiratory depression as measured by the proportion of subjects who experienced respiratory depression during a diagnostic upper GI endoscopy
time frame: From start of study drug injection to patient discharge (approx. 3 hours)
measure: pain on injection was assessed by the patient immediately after administration of the study drug
time frame: 1-10 minutes (from the beginning of sedation )]
arm group label: Remimazolam Tosilate 1
arm group type: Experimental
description: IV of Remimazolam Tosilate at 5mg for initial dose
arm group label: Remimazolam Tosilate 2
arm group type: Experimental
description: IV of Remimazolam Tosilate at 7mg for initial dose
arm group label: Remimazolam Tosilate 3
arm group type: Experimental
description: IV of Remimazolam Tosilate at 8mg for initial dose
arm group label: Remimazolam Tosilate 4
arm group type: Experimental
description: IV of Remimazolam Tosilate at 5mg for initial dose.At the end of the endoscopy, flumazenil was injected.
arm group label: Propofol
arm group type: Active Comparator
description: IV of Propofol at 1.5mg/kg for initial dose
intervention type: Drug
intervention name: Remimazolam Tosilate
description: Initial dose plus supplemental doses as necessary.
arm group label: Remimazolam Tosilate 1
arm group label: Remimazolam Tosilate 2
arm group label: Remimazolam Tosilate 3
arm group label: Remimazolam Tosilate 4
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: 60 Years
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor
mesh term: Propofol