<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/NCT02250924</url>
  </required_header>
  <id_info>
    <org_study_id>GC1410-55</org_study_id>
    <nct_id>NCT02250924</nct_id>
  </id_info>
  <brief_title>Caffeinated Gum to Prevent Post-Operative Ileus: A Prospective, Randomized, Placebo-controlled Trial</brief_title>
  <official_title>Caffeinated Gum to Prevent Post-Operative Ileus: A Prospective, Randomized, Placebo-controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Guthrie Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Guthrie Clinic</source>
  <oversight_info>
    <has_dmc>No</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>
      This is a randomized, three-arm, double-blind, placebo-controlled, Phase III clinical trial&#xD;
      of caffeinated gum and sugar-less gum in adult patients after an abdominal procedure.&#xD;
      Patients will be randomized to receive placebo, sugar-less gum or caffeinated gum three times&#xD;
      daily for 30 minutes starting the day following surgery until discharge or 24 hours after&#xD;
      attainment of the primary endpoint.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Investigator decision - clinical practice change&#xD;
  </why_stopped>
  <start_date type="Anticipated">January 2017</start_date>
  <completion_date type="Actual">May 28, 2020</completion_date>
  <primary_completion_date type="Actual">May 2020</primary_completion_date>
  <phase>N/A</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>Supportive Care</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean time to GI function recovery (GI-3)</measure>
    <time_frame>An expected average of 5 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean length of postoperative hospitalization</measure>
    <time_frame>Up to 30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of postoperative ileus</measure>
    <time_frame>Up to 30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse event rates</measure>
    <time_frame>Up to 30 days postoperative</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>C.Surgical Procedure; Digestive System</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects will wear a silicone bracelet for 30 minutes 3 times daily at 8 am, 12 pm and 4 pm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sugar-less Gum</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Subjects will chew one stick of sugar-less gum for 30 minutes 3 times daily at 8 am, 12 pm and 4 pm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Caffeinated Gum</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will chew one stick of caffeinated gum (100mg caffeine per stick) for 30 minutes 3 times daily at 8 am, 12 pm and 4 pm.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Caffeine</intervention_name>
    <description>caffeinated gum</description>
    <arm_group_label>Caffeinated Gum</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Gum</intervention_name>
    <description>Chewing gum</description>
    <arm_group_label>Caffeinated Gum</arm_group_label>
    <arm_group_label>Sugar-less Gum</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>wear silicone bracelet</intervention_name>
    <description>Subjects will put on bracelet to correspond with times for chewing gum</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Abdominal procedure (Laparoscopic or open, occurring electively), American Society of&#xD;
             Anesthesiologists (ASA) physical status score ≤ 3, Glasgow Coma Score (GCS) ≥ 15.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ASA physical status score of &gt;3, GCS &lt; 15, complete bowel obstruction, history of&#xD;
             cardiac arrhythmia, history of phenylketonuria, alcohol abuse. substance abuse&#xD;
             dentures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Karim Sadik, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Guthrie Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Guthrie Clinic</name>
      <address>
        <city>Sayre</city>
        <state>Pennsylvania</state>
        <zip>18840</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>September 22, 2014</study_first_submitted>
  <study_first_submitted_qc>September 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <last_update_submitted>June 1, 2020</last_update_submitted>
  <last_update_submitted_qc>June 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</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>Caffeine</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/NCT02250924
org study id: GC1410-55
nct id: NCT02250924
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a randomized, three-arm, double-blind, placebo-controlled, Phase III clinical trial
      of caffeinated gum and sugar-less gum in adult patients after an abdominal procedure.
      Patients will be randomized to receive placebo, sugar-less gum or caffeinated gum three times
      daily for 30 minutes starting the day following surgery until discharge or 24 hours after
      attainment of the primary endpoint.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Mean time to GI function recovery (GI-3)
time frame: An expected average of 5 days
measure: Mean length of postoperative hospitalization
time frame: Up to 30 days
measure: Rate of postoperative ileus
time frame: Up to 30 days
measure: Adverse event rates
time frame: Up to 30 days postoperative
arm group label: Placebo
arm group type: Placebo Comparator
description: Subjects will wear a silicone bracelet for 30 minutes 3 times daily at 8 am, 12 pm and 4 pm.
arm group label: Sugar-less Gum
arm group type: Sham Comparator
description: Subjects will chew one stick of sugar-less gum for 30 minutes 3 times daily at 8 am, 12 pm and 4 pm.
arm group label: Caffeinated Gum
arm group type: Experimental
description: Subjects will chew one stick of caffeinated gum (100mg caffeine per stick) for 30 minutes 3 times daily at 8 am, 12 pm and 4 pm.
intervention type: Dietary Supplement
intervention name: Caffeine
description: caffeinated gum
arm group label: Caffeinated Gum
intervention type: Other
intervention name: Gum
description: Chewing gum
arm group label: Caffeinated Gum
arm group label: Sugar-less Gum
intervention type: Behavioral
intervention name: wear silicone bracelet
description: Subjects will put on bracelet to correspond with times for chewing gum
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Karim Sadik, MD
role: Principal Investigator
affiliation: The Guthrie Clinic
facility: 
country: United States
responsible party type: Sponsor
mesh term: Caffeine