<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/NCT03773042</url>
  </required_header>
  <id_info>
    <org_study_id>HSK3486-201</org_study_id>
    <nct_id>NCT03773042</nct_id>
  </id_info>
  <brief_title>A Study Evaluating Tolerability, Efficacy, and Safety of HSK3486 Injectable Emulsion in Patients</brief_title>
  <official_title>A Phase IIa, Multi-center, Open-label, Non-randomized, Active-controlled, and Dose-escalation Clinical Study Evaluating Tolerability, Efficacy, and Safety of HSK3486 Injectable Emulsion for Sedation/Anesthesia in Patients Undergoing Diagnostic Colonoscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sichuan Haisco Pharmaceutical Group Co., Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Haisco Pharmaceutical Group 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>
      A double-blind, randomized, active controlled, multi-center, parallel group study comparing&#xD;
      HSK3486 with Propofol, in patients undergoing a colonoscopy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">June 2017</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of successful colonoscopies.</measure>
    <time_frame>From the first dose of the study drug to removal of colonoscope on day 1</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Insertion time</measure>
    <time_frame>From the first dose of study drug until insertion of colonoscope on day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The success rate of the colonoscopy procedure</measure>
    <time_frame>From the first dose of the study drug to removal of colonoscope on day 1</time_frame>
    <description>The number of patients who successfully completed the colonoscopy procedure accounted for the proportion of all patients in the dose group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to fully alert</measure>
    <time_frame>From the removal of colonoscopy procedure, until the first of three consecutive MOAA/S scores of 5 on day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to discharge</measure>
    <time_frame>From the removal of colonoscopy procedure, until the first of three consecutive MOAA/S scores of 9 on day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Application of study drug and alternative medication</measure>
    <time_frame>During the colonoscopy procedure on day 1</time_frame>
    <description>Total dosages of study drug and alternative medication</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mini-Mental State Examinations (MMSE)</measure>
    <time_frame>During the screening and the colonoscopy procedure on day 1</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Colonoscopy</condition>
  <arm_group>
    <arm_group_label>HSK3486</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>0.1mg/kg, 0.2mg/kg, 0.3mg/kg, 0.4mg/kg, 0.5mg/kg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Propofol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>1.0mg/kg, 2.0mg/kg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>HSK3486</intervention_name>
    <description>For induction and maintenance of sedation.</description>
    <arm_group_label>HSK3486</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Propofol</intervention_name>
    <description>For induction and maintenance of sedation.</description>
    <arm_group_label>Propofol</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria (those who meet all of the following are eligible)&#xD;
&#xD;
          1. Patients requiring diagnostic colonoscopy with an estimated examination time ≤ 30 min;&#xD;
             males and females, ASA grade I-II, between 18 and 65 years old (inclusive);&#xD;
&#xD;
          2. Body mass index (BMI) ≥ 18 and ≤ 30 kg/m2&#xD;
&#xD;
          3. Respiratory rate between ≥ 10 and ≤ 24 breaths per minute; SpO2 when inhaling &gt; 95%;&#xD;
             SBP ≥ 90 mmHg; DBP ≥ 60 mmHg; heart rate between ≥ 50 and ≤ 100 beats per minute;&#xD;
&#xD;
          4. Subjects must understand the procedures and methods of this study, and be willing to&#xD;
             provide informed consent and to complete the trial in strict accordance with clinical&#xD;
             trial protocol.&#xD;
&#xD;
        Exclusion Criteria (those who meet any one of the following are ineligible):&#xD;
&#xD;
          1. Patients having contraindications to general anesthesia or previous history of&#xD;
             anesthesia accidents;&#xD;
&#xD;
          2. Patients with a known sensitivity to propofol, opioids, naloxone, eggs, soy products&#xD;
             or a medical condition such that these agents were contraindicated;&#xD;
&#xD;
          3. Patient received any of the following drugs or therapies prior to screening:&#xD;
&#xD;
               1. Participated in other drug clinical trials within 3 month prior to screening;&#xD;
&#xD;
               2. In receipt of propofol and/or opioid analgesics within 1 month prior to&#xD;
                  screening;&#xD;
&#xD;
          4. The patient has some history or evidence of increased risk of sedation or anesthesia,&#xD;
             such as cardiovascular disease, respiratory disease, cerebrovascular disease,&#xD;
             gastrodintestinal disease and other system disease prior to the screening and/or&#xD;
             baseline period.&#xD;
&#xD;
          5. Patient whose laboratory parameters measured at screening/prior to enrollment reach&#xD;
             the following criteria and verified through re-examinations:&#xD;
&#xD;
               1. ANC ≤ 1.5 x 109/L;&#xD;
&#xD;
               2. PLT ≤ 80 x 109/L;&#xD;
&#xD;
               3. Hb ≤ 90 g/L (no blood transfusion within the last 14 days);&#xD;
&#xD;
               4. AST and ALT ≥ 2.5 x ULN;&#xD;
&#xD;
               5. TBIL ≥ 1.5 x ULN;&#xD;
&#xD;
               6. Creatinine ≥ 1.5 x ULN.&#xD;
&#xD;
          6. History of alcohol abuse within 3 months prior to screening or with a positive result&#xD;
             of alcohol saliva strip test (before dose);&#xD;
&#xD;
          7. History of medication abuse within 3 months prior to screening, or a positive urine&#xD;
             medication test (during screening or before dose administration);&#xD;
&#xD;
          8. Women who are pregnant or breastfeeding; women of child-bearing potential or men who&#xD;
             are unwilling to use contraception during the trial; Patients who are planning&#xD;
             pregnancy within 1 month after the completion of the trial (including male patients);&#xD;
&#xD;
          9. Potential difficult airway or difficult tracheal intubation, as determined by the&#xD;
             investigator, and/or history of intubation failure;&#xD;
&#xD;
         10. Patients determined by the investigator to be unsuitable for participating in this&#xD;
             trial for any reason.&#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>West China Hospital, Sichuan University</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <last_update_submitted>December 11, 2018</last_update_submitted>
  <last_update_submitted_qc>December 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 13, 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>
  <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/NCT03773042
org study id: HSK3486-201
nct id: NCT03773042
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A double-blind, randomized, active controlled, multi-center, parallel group study comparing
      HSK3486 with Propofol, in patients undergoing a colonoscopy.
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Rate of successful colonoscopies.
time frame: From the first dose of the study drug to removal of colonoscope on day 1
measure: Insertion time
time frame: From the first dose of study drug until insertion of colonoscope on day 1
measure: The success rate of the colonoscopy procedure
time frame: From the first dose of the study drug to removal of colonoscope on day 1
description: The number of patients who successfully completed the colonoscopy procedure accounted for the proportion of all patients in the dose group
measure: Time to fully alert
time frame: From the removal of colonoscopy procedure, until the first of three consecutive MOAA/S scores of 5 on day 1
measure: Time to discharge
time frame: From the removal of colonoscopy procedure, until the first of three consecutive MOAA/S scores of 9 on day 1
measure: Application of study drug and alternative medication
time frame: During the colonoscopy procedure on day 1
description: Total dosages of study drug and alternative medication
measure: Mini-Mental State Examinations (MMSE)
time frame: During the screening and the colonoscopy procedure on day 1
arm group label: HSK3486
arm group type: Experimental
description: 0.1mg/kg, 0.2mg/kg, 0.3mg/kg, 0.4mg/kg, 0.5mg/kg
arm group label: Propofol
arm group type: Active Comparator
description: 1.0mg/kg, 2.0mg/kg
intervention type: Drug
intervention name: HSK3486
description: For induction and maintenance of sedation.
arm group label: HSK3486
intervention type: Drug
intervention name: Propofol
description: For induction and maintenance of sedation.
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
sharing ipd: No