xml: <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/NCT06041984</url>
    </required_header>
    <id_info>
      <org_study_id>2023114</org_study_id>
      <nct_id>NCT06041984</nct_id>
    </id_info>
    <brief_title>Antiperistaltic Effect and Safety of Glycopyrronium for Colonoscopic Polypectomy</brief_title>
    <official_title>Antiperistaltic Effect and Safety of Glycopyrronium for Colonoscopic Polypectomy: a Randomized, Double-blind, Placebo-controlled Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Jie Chen</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The Second Affiliated Hospital of Chongqing Medical University</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>
        The purpose of this study is to determine the antiperistaltic effect and safety of&#xD;
        glycopyrrolate and whether the use of glycopyrrolate is beneficial for colonoscopic&#xD;
        polypectomy.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Colonic spasm is a major adverse event affecting colonoscopy.The current mainstay for the&#xD;
        prevention of colonic spasm is the use of antispasmodic.Glycopyrrolate is a long-acting&#xD;
        quaternary ammonium anticholinergic drug.The study is designed as a randomized, double-blind,&#xD;
        placebo-controlled study of the efficacy and safety of glycopyrrolate in participants&#xD;
        receiving colonoscopic polypectomy. Patients at our center who met the inclusion criteria&#xD;
        were randomized into the glycopyrrolate group and the placebo group, and then statistically&#xD;
        analyzed whether there was any difference in the incidence of spasticity, spasticity scores,&#xD;
        polyp treatment time, and satisfaction with endoscopist operation between the two groups.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">June 2024</completion_date>
    <primary_completion_date type="Anticipated">April 2024</primary_completion_date>
    <phase>Phase 1/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>Treatment</primary_purpose>
      <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Incidence of intestinal spasm</measure>
      <time_frame>During Colonoscopy</time_frame>
      <description>The incidence of intestinal spasm in the two groups was calculated after determining whether colonic spasms occurred according to the inhibitory effect score.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>inhibitory effect score</measure>
      <time_frame>During Colonoscopy</time_frame>
      <description>Rated on a scale of 1 to 3 according to the luminal opening diameter:1 (excellent): no spasm,lumen opening ≥ 2/3 of maximum diameter， 2 (fair): moderate spasm，lumen opening &lt; 2/3 of maximum diameter, but the oral side can be seen and 3 (poor): severe spasm，the oral side lumen is not visible.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Polyp Treatment Time</measure>
      <time_frame>During Colonoscopy</time_frame>
      <description>Time from start of polyp removal to complete polyp removal.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Glycopyrrolate</condition>
    <condition>Colonoscopy</condition>
    <arm_group>
      <arm_group_label>Glycopyrrolate</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive intravenous glycopyrrolate 0.2 mg while receiving anesthetic.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Participants will receive intravenous 1ml saline while receiving anesthetic.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Glycopyrrolate</intervention_name>
      <description>Intravenous injection of glycopyrrolate 0.2mg</description>
      <arm_group_label>Glycopyrrolate</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Intravenous injection of saline 1ml</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 18-80 years old.&#xD;
  &#xD;
            -  Outpatients and inpatients with lesions to be resected under colonoscopy.&#xD;
  &#xD;
            -  Participants voluntarily participated and signed informed consent forms.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnancy status and lactating women.&#xD;
  &#xD;
            -  With glaucoma, myasthenia gravis, hyperthyroidism, chronic renal insufficiency, and&#xD;
               inflammatory bowel disease.&#xD;
  &#xD;
            -  With obstructive gastrointestinal diseases such as pyloric obstruction, paralytic&#xD;
               ileus, and achalasia of the cardia.&#xD;
  &#xD;
            -  With obstructive urinary tract diseases such as prostatic hyperplasia and dysuria.&#xD;
  &#xD;
            -  With heart disease such as arrhythmia (bradycardia, tachycardia, ventricular&#xD;
               fibrillation, atrial fibrillation, etc.), coronary heart disease, congestive heart&#xD;
               failure.&#xD;
  &#xD;
            -  With a history of previous abdominal or intestinal surgery.&#xD;
  &#xD;
            -  Anticholinergic drugs were administered 48 hours before surgery.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Guangyou Duan, doctor</last_name>
      <role>Study Director</role>
      <affiliation>The Second Affiliated Hospital of Chongqing Medical University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jie Chen, bachelor</last_name>
      <phone>13527517763</phone>
      <email>305045@hospital.cqmu.edu.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Duan</last_name>
    </overall_contact_backup>
    <location>
      <facility>
        <name>The Second Affiliated Hospital Of Chongqing Medical University</name>
        <address>
          <city>Chongqing</city>
          <state>Chongqing</state>
          <zip>400000</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 12, 2023</study_first_submitted>
    <study_first_submitted_qc>September 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>The Second Affiliated Hospital of Chongqing Medical University</investigator_affiliation>
      <investigator_full_name>Jie Chen</investigator_full_name>
      <investigator_title>deputy chief physician</investigator_title>
    </responsible_party>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Glycopyrrolate</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06041984
  org study id: 2023114
  nct id: NCT06041984
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to determine the antiperistaltic effect and safety of
        glycopyrrolate and whether the use of glycopyrrolate is beneficial for colonoscopic
        polypectomy.
  Colonic spasm is a major adverse event affecting colonoscopy.The current mainstay for the
        prevention of colonic spasm is the use of antispasmodic.Glycopyrrolate is a long-acting
        quaternary ammonium anticholinergic drug.The study is designed as a randomized, double-blind,
        placebo-controlled study of the efficacy and safety of glycopyrrolate in participants
        receiving colonoscopic polypectomy. Patients at our center who met the inclusion criteria
        were randomized into the glycopyrrolate group and the placebo group, and then statistically
        analyzed whether there was any difference in the incidence of spasticity, spasticity scores,
        polyp treatment time, and satisfaction with endoscopist operation between the two groups.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Care Provider, Outcomes Assessor)
  measure: Incidence of intestinal spasm
  time frame: During Colonoscopy
  description: The incidence of intestinal spasm in the two groups was calculated after determining whether colonic spasms occurred according to the inhibitory effect score.
  measure: inhibitory effect score
  time frame: During Colonoscopy
  description: Rated on a scale of 1 to 3 according to the luminal opening diameter:1 (excellent): no spasm,lumen opening ≥ 2/3 of maximum diameter， 2 (fair): moderate spasm，lumen opening < 2/3 of maximum diameter, but the oral side can be seen and 3 (poor): severe spasm，the oral side lumen is not visible.
  measure: Polyp Treatment Time
  time frame: During Colonoscopy
  description: Time from start of polyp removal to complete polyp removal.
  arm group label: Glycopyrrolate
  arm group type: Experimental
  description: Participants will receive intravenous glycopyrrolate 0.2 mg while receiving anesthetic.
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Participants will receive intravenous 1ml saline while receiving anesthetic.
  intervention type: Drug
  intervention name: Glycopyrrolate
  description: Intravenous injection of glycopyrrolate 0.2mg
  arm group label: Glycopyrrolate
  intervention type: Other
  intervention name: Placebo
  description: Intravenous injection of saline 1ml
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Guangyou Duan, doctor
  role: Study Director
  affiliation: The Second Affiliated Hospital of Chongqing Medical University
  last name: Jie Chen, bachelor
  phone: 13527517763
  email: 305045@hospital.cqmu.edu.cn
  last name: Duan
  facility: 
  country: China
  responsible party type: Sponsor-Investigator
  investigator affiliation: The Second Affiliated Hospital of Chongqing Medical University
  investigator full name: Jie Chen
  investigator title: deputy chief physician
  mesh term: Glycopyrrolate
  sharing ipd: No