<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/NCT03247595</url>
  </required_header>
  <id_info>
    <org_study_id>1031752</org_study_id>
    <nct_id>NCT03247595</nct_id>
  </id_info>
  <brief_title>Testing How Well Magnesium Citrate Capsules Work as Preparation for a Colonoscopy</brief_title>
  <official_title>Efficacy of Magnesium Citrate Capsules in Colonoscopy Preparation: A Randomized, Investigator-blinded Non-inferiority Trial Using Polyethylene Glycol as the Active Control.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>LifeBridge Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>LifeBridge Health</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study compares a colonoscopy preparation composed of magnesium citrate capsules to a&#xD;
      preparation of polyethylene glycol solution. The hypothesis is that the magnesium citrate&#xD;
      capsules work as well and are better liked by patients due to the lack of taste.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 26, 2017</start_date>
  <completion_date type="Actual">June 16, 2020</completion_date>
  <primary_completion_date type="Actual">June 16, 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>
    <intervention_model_description>One arm receives Polyethelyne Glycol colonoscopy preparation and the other arm receives magnesium citrate capsules colonoscopy preparation.</intervention_model_description>
    <primary_purpose>Screening</primary_purpose>
    <masking>Single (Investigator)</masking>
    <masking_description>The endoscopist who reports colon cleanliness is blinded to the subject's assignment.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Colon Cleanliness</measure>
    <time_frame>During colonoscopy</time_frame>
    <description>Boston scale rating of colon cleanliness</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient compliance and satisfaction</measure>
    <time_frame>On the day of colonoscopy</time_frame>
    <description>Patient's experience recorded in a questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">62</enrollment>
  <condition>Colonoscopy</condition>
  <arm_group>
    <arm_group_label>Polyethylene Glycol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Polyethylene Glycol 3350: 4 Liters</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Magnesium Citrate Capsules</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>36 Magnesium citrate capsules</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Magnesium Citrate Capsules</intervention_name>
    <description>36 magnesium citrate gelatin capsules</description>
    <arm_group_label>Magnesium Citrate Capsules</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Polyethylene Glycol 3350</intervention_name>
    <description>4 liters of Polyethylene Glycol for colonoscopy preparation</description>
    <arm_group_label>Polyethylene Glycol</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Dulcolax Tablets</intervention_name>
    <description>4 Dulcolox Tablets</description>
    <arm_group_label>Magnesium Citrate Capsules</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Scheduled for colonoscopy at Sinai Hospital or Woodholme GI Associates&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Calculated creatinine clearance under 30ml/min&#xD;
&#xD;
               -  On PPI and unable to stop for five days before colonoscopy&#xD;
&#xD;
               -  On H2 blockers and unable to stop for two days before colonoscopy&#xD;
&#xD;
               -  achlorhydria&#xD;
&#xD;
               -  Previous colon surgery&#xD;
&#xD;
               -  Cardiovascular disease, including uncontrolled congestive heart failure, unstable&#xD;
                  angina pectoris, or recent (3 months) percutaneous transluminal coronary&#xD;
                  angioplasty, myocardial infarction, or coronary artery bypass graft surgery&#xD;
&#xD;
               -  Colon disease, including chronic constipation (&lt;2 bowel movements per week for &gt;1&#xD;
                  year), ileus and/or acute obstruction, ileostomy, right or transverse colostomy,&#xD;
                  subtotal colectomy (≥50% of colon removed) with ileosigmoidostomy, hypomotility&#xD;
                  syndrome, megacolon, or idiopathic pseudo-obstruction&#xD;
&#xD;
               -  Pregnant women&#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>Ethan Dubin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>LifeBridge Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Woodholme Gastroenterology</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sinai Hospital</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Rex DK, Johnson DA, Anderson JC, Schoenfeld PS, Burke CA, Inadomi JM; American College of Gastroenterology. American College of Gastroenterology guidelines for colorectal cancer screening 2009 [corrected]. Am J Gastroenterol. 2009 Mar;104(3):739-50. doi: 10.1038/ajg.2009.104. Epub 2009 Feb 24. Erratum In: Am J Gastroenterol. 2009 Jun;104(6):1613.</citation>
    <PMID>19240699</PMID>
  </reference>
  <reference>
    <citation>Kastenberg D, Barish C, Burack H, Dalke DD, Duckor S, Putnam W, Valenzuela G; INKP-100 Study Group. Tolerability and patient acceptance of sodium phosphate tablets compared with 4-L PEG solution in colon cleansing: combined results of 2 identically designed, randomized, controlled, parallel group, multicenter phase 3 trials. J Clin Gastroenterol. 2007 Jan;41(1):54-61. doi: 10.1097/01.mcg.0000212662.66644.76.</citation>
    <PMID>17198066</PMID>
  </reference>
  <reference>
    <citation>Flemming JA, Vanner SJ, Hookey LC. Split-dose picosulfate, magnesium oxide, and citric acid solution markedly enhances colon cleansing before colonoscopy: a randomized, controlled trial. Gastrointest Endosc. 2012 Mar;75(3):537-44. doi: 10.1016/j.gie.2011.09.018. Epub 2011 Dec 21.</citation>
    <PMID>22192423</PMID>
  </reference>
  <reference>
    <citation>Lindberg JS, Zobitz MM, Poindexter JR, Pak CY. Magnesium bioavailability from magnesium citrate and magnesium oxide. J Am Coll Nutr. 1990 Feb;9(1):48-55. doi: 10.1080/07315724.1990.10720349.</citation>
    <PMID>2407766</PMID>
  </reference>
  <reference>
    <citation>Calderwood AH, Schroy PC 3rd, Lieberman DA, Logan JR, Zurfluh M, Jacobson BC. Boston Bowel Preparation Scale scores provide a standardized definition of adequate for describing bowel cleanliness. Gastrointest Endosc. 2014 Aug;80(2):269-76. doi: 10.1016/j.gie.2014.01.031. Epub 2014 Mar 12.</citation>
    <PMID>24629422</PMID>
  </reference>
  <reference>
    <citation>Kastenberg D, Chasen R, Choudhary C, Riff D, Steinberg S, Weiss E, Wruble L. Efficacy and safety of sodium phosphate tablets compared with PEG solution in colon cleansing: two identically designed, randomized, controlled, parallel group, multicenter phase III trials. Gastrointest Endosc. 2001 Dec;54(6):705-13. doi: 10.1067/mge.2001.119733.</citation>
    <PMID>11726845</PMID>
  </reference>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>March 8, 2021</last_update_submitted>
  <last_update_submitted_qc>March 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Colonoscopy preparation</keyword>
  <keyword>Magnesium Citrate Capsules</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Magnesium citrate</mesh_term>
    <mesh_term>Bisacodyl</mesh_term>
    <mesh_term>Polyethylene glycol 3350</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03247595
org study id: 1031752
nct id: NCT03247595
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study compares a colonoscopy preparation composed of magnesium citrate capsules to a
      preparation of polyethylene glycol solution. The hypothesis is that the magnesium citrate
      capsules work as well and are better liked by patients due to the lack of taste.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: One arm receives Polyethelyne Glycol colonoscopy preparation and the other arm receives magnesium citrate capsules colonoscopy preparation.
primary purpose: Screening
masking: Single (Investigator)
masking description: The endoscopist who reports colon cleanliness is blinded to the subject's assignment.
measure: Colon Cleanliness
time frame: During colonoscopy
description: Boston scale rating of colon cleanliness
measure: Patient compliance and satisfaction
time frame: On the day of colonoscopy
description: Patient's experience recorded in a questionnaire
arm group label: Polyethylene Glycol
arm group type: Active Comparator
description: Polyethylene Glycol 3350: 4 Liters
arm group label: Magnesium Citrate Capsules
arm group type: Experimental
description: 36 Magnesium citrate capsules
intervention type: Dietary Supplement
intervention name: Magnesium Citrate Capsules
description: 36 magnesium citrate gelatin capsules
arm group label: Magnesium Citrate Capsules
intervention type: Other
intervention name: Polyethylene Glycol 3350
description: 4 liters of Polyethylene Glycol for colonoscopy preparation
arm group label: Polyethylene Glycol
intervention type: Other
intervention name: Dulcolax Tablets
description: 4 Dulcolox Tablets
arm group label: Magnesium Citrate Capsules
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ethan Dubin, MD
role: Principal Investigator
affiliation: LifeBridge Health
facility: 
facility: 
country: United States
citation: Rex DK, Johnson DA, Anderson JC, Schoenfeld PS, Burke CA, Inadomi JM; American College of Gastroenterology. American College of Gastroenterology guidelines for colorectal cancer screening 2009 [corrected]. Am J Gastroenterol. 2009 Mar;104(3):739-50. doi: 10.1038/ajg.2009.104. Epub 2009 Feb 24. Erratum In: Am J Gastroenterol. 2009 Jun;104(6):1613.
PMID: 19240699
citation: Kastenberg D, Barish C, Burack H, Dalke DD, Duckor S, Putnam W, Valenzuela G; INKP-100 Study Group. Tolerability and patient acceptance of sodium phosphate tablets compared with 4-L PEG solution in colon cleansing: combined results of 2 identically designed, randomized, controlled, parallel group, multicenter phase 3 trials. J Clin Gastroenterol. 2007 Jan;41(1):54-61. doi: 10.1097/01.mcg.0000212662.66644.76.
PMID: 17198066
citation: Flemming JA, Vanner SJ, Hookey LC. Split-dose picosulfate, magnesium oxide, and citric acid solution markedly enhances colon cleansing before colonoscopy: a randomized, controlled trial. Gastrointest Endosc. 2012 Mar;75(3):537-44. doi: 10.1016/j.gie.2011.09.018. Epub 2011 Dec 21.
PMID: 22192423
citation: Lindberg JS, Zobitz MM, Poindexter JR, Pak CY. Magnesium bioavailability from magnesium citrate and magnesium oxide. J Am Coll Nutr. 1990 Feb;9(1):48-55. doi: 10.1080/07315724.1990.10720349.
PMID: 2407766
citation: Calderwood AH, Schroy PC 3rd, Lieberman DA, Logan JR, Zurfluh M, Jacobson BC. Boston Bowel Preparation Scale scores provide a standardized definition of adequate for describing bowel cleanliness. Gastrointest Endosc. 2014 Aug;80(2):269-76. doi: 10.1016/j.gie.2014.01.031. Epub 2014 Mar 12.
PMID: 24629422
citation: Kastenberg D, Chasen R, Choudhary C, Riff D, Steinberg S, Weiss E, Wruble L. Efficacy and safety of sodium phosphate tablets compared with PEG solution in colon cleansing: two identically designed, randomized, controlled, parallel group, multicenter phase III trials. Gastrointest Endosc. 2001 Dec;54(6):705-13. doi: 10.1067/mge.2001.119733.
PMID: 11726845
responsible party type: Sponsor
mesh term: Magnesium citrate
mesh term: Bisacodyl
mesh term: Polyethylene glycol 3350
sharing ipd: Undecided