<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/NCT01705262</url>
  </required_header>
  <id_info>
    <org_study_id>AAX-001</org_study_id>
    <nct_id>NCT01705262</nct_id>
  </id_info>
  <brief_title>Comparing Oral Preparation With Macrogol (Moviprep) and Natriumdihydrogenphosphatdihydrat (Phosphoral)</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Odense University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Odense University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether Moviprep or Phosphoral is the best method&#xD;
      of bowel preparation before colonoscopy - seen by the patients and by the endoscopist.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Phophoral was no longer used as a preparation before coloscopies at OUH&#xD;
  </why_stopped>
  <start_date>October 2010</start_date>
  <completion_date type="Actual">October 2012</completion_date>
  <primary_completion_date type="Actual">October 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">80</enrollment>
  <condition>Colonoscopy</condition>
  <arm_group>
    <arm_group_label>u-65 M</arm_group_label>
    <description>Male patients under 65</description>
  </arm_group>
  <arm_group>
    <arm_group_label>u-65 K</arm_group_label>
    <description>Female patients under 65 years old</description>
  </arm_group>
  <arm_group>
    <arm_group_label>o-65 -K</arm_group_label>
    <description>Female patients over 65 years</description>
  </arm_group>
  <arm_group>
    <arm_group_label>O-65 M</arm_group_label>
    <description>Male patients over 65 years</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients referred to colonoscopy by the house doctors&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  primary diagnostic colonoscopy,&#xD;
&#xD;
          -  colonoscopy as a follow-up,&#xD;
&#xD;
          -  intended therapeutic colonoscopy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients younger than 18 years&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  known bowl obstructions&#xD;
&#xD;
          -  known inflammatory colon disease&#xD;
&#xD;
          -  known kidney disease&#xD;
&#xD;
          -  phenylketonuri&#xD;
&#xD;
          -  glucose-6-phospat deficiency&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Surgery department</name>
      <address>
        <city>Odense</city>
        <zip>5250</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>January 27, 2012</study_first_submitted>
  <study_first_submitted_qc>October 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 12, 2012</study_first_posted>
  <last_update_submitted>April 3, 2017</last_update_submitted>
  <last_update_submitted_qc>April 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Odense University Hospital</investigator_affiliation>
    <investigator_full_name>Anne Reiss Axelsen</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>compliance</keyword>
  <keyword>Bowel preparations</keyword>
  <keyword>Moviprep</keyword>
  <keyword>Phosphoral</keyword>
  <!-- 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/NCT01705262
org study id: AAX-001
nct id: NCT01705262
lead sponsor: 
has dmc: No
The purpose of this study is to determine whether Moviprep or Phosphoral is the best method
      of bowel preparation before colonoscopy - seen by the patients and by the endoscopist.
observational model: Case-Only
time perspective: Prospective
arm group label: u-65 M
description: Male patients under 65
arm group label: u-65 K
description: Female patients under 65 years old
arm group label: o-65 -K
description: Female patients over 65 years
arm group label: O-65 M
description: Male patients over 65 years
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Odense University Hospital
investigator full name: Anne Reiss Axelsen
investigator title: MD