<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/NCT04457934</url>
  </required_header>
  <id_info>
    <org_study_id>001</org_study_id>
    <secondary_id>125</secondary_id>
    <nct_id>NCT04457934</nct_id>
  </id_info>
  <brief_title>Effectiveness of PLENVU in the General Screening Population and Patients With IBD</brief_title>
  <official_title>Effectiveness of PLENVU in the General Screening Population and Patients With IBD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johannes Gutenberg University Mainz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johannes Gutenberg University Mainz</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients presenting for endoscopic surveillance of IBD or colorectal screening colonoscopy at&#xD;
      one of the participating centers will be asked to participate in the present study after&#xD;
      careful evaluation of inclusion and exclusion criteria. The aim is that the final study&#xD;
      population will comprise of 50% IBD patients and 50% colorectal cancer screening patients.&#xD;
      Before inclusion, all patients have to sign the written informed consent. All participating&#xD;
      patients will receive PLENVU, a well-known and approved bowel preparation agent. Bowel&#xD;
      preparation is performed following the general recommendations of use. Following the bowel&#xD;
      preparation, patients are asked if they have well tolerated the preparation, if they already&#xD;
      had a colonoscopy in the past with another bowel preparation agent and if they would prefer&#xD;
      PLENVU or another bowel preparation for their next endoscopy examination. Endoscopy is&#xD;
      performed in standard way and effectiveness of the bowel preparation is specifically&#xD;
      highlighted by the physician on the documentation report. Finally, data is analyzed regarding&#xD;
      effectiveness of PLENVU for bowel preparation and patient satisfaction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PLENVU is effective for bowel preparation and the efficacy and safety of PLENVU has been&#xD;
      investigated in randomized controlled trials in patients undergoing gut cleansing prior to&#xD;
      colonoscopy. Data on the specific screening population and for patients suffering from IBD&#xD;
      however is limited to date. The aim of the current study is to fill this gap and to provide&#xD;
      data of the effectiveness of PLENVU for the specific patients groups in order to provide&#xD;
      specific recommendations for an adequate bowel preparation in those groups.&#xD;
&#xD;
      In general, bowel-preparation in IBD patients is often more challenging. This might be due to&#xD;
      the chronic disease burden but also according to compliance factors of individual patients.&#xD;
      Of note, an adequate bowel-preparation is of paramount importance in IBD in order to detect&#xD;
      subtle neoplasia and to perform chromoendoscopy, which is still recommended by the updated&#xD;
      ESGE guideline.&#xD;
&#xD;
      It is anticipated, that PLENVU will help IBD patients to achieve a better bowel preparation,&#xD;
      thereby yielding in more effective screening colonoscopies and higher acceptance rates of&#xD;
      patients for surveillance colonoscopies. In order to show that no significant differences are&#xD;
      seen in the included IBD cohort compared to the general screening population (bias risk), the&#xD;
      investigators aim to also include patients from the normal screening population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">September 2020</start_date>
  <completion_date type="Anticipated">August 2021</completion_date>
  <primary_completion_date type="Anticipated">January 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Boston Bowel Preparation Standard (BBPS)</measure>
    <time_frame>1 week</time_frame>
    <description>Bowel preparation according to international Standard (1 is bad, 9 is good), how many BBPs with 9 can be achieved?</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with treatment-related adverse events as assessed by CTCAE v4.0</measure>
    <time_frame>1 day</time_frame>
    <description>How good will patients tolerate endoscopy and preparation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to 1 week</time_frame>
    <description>What Kind of adverse Events can happen during this study</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients who are willing to accept repeated examination (surveillance);</measure>
    <time_frame>up to 1 month</time_frame>
    <description>How many patients will come back for another endoscopy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adenoma and Polyp Detection Rate (ADR and PDR)</measure>
    <time_frame>1 day</time_frame>
    <description>How many adenomas and polyps are detected during endoscopy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cecal intubation rate</measure>
    <time_frame>1 day</time_frame>
    <description>how many endoscopies will reach the ceacum</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>procedure time</measure>
    <time_frame>3 hours</time_frame>
    <description>how Long will endoscopy take</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">290</enrollment>
  <condition>IBD</condition>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>IBD patients</arm_group_label>
    <description>Patients with IBD will undergo preparation for Standard endoscopy with PLENVU, since it is considered to be less affecting for patients. IBD patients have to undergo endoscopy often and mostly suffer from non-efficient preparation.&#xD;
Patients will drink 1 Liter of Plenvu and 1 Liter of water or tea in preparation for endoscopy and will follow the Guidelines for preparation of endoscopy.&#xD;
The only Change from Standard care is that patients will receive Plenvu instead of Movicol.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Screening patients</arm_group_label>
    <description>Screening patients will undergo Standard endoscopy to prevent colon Cancer. Patients will drink 1 Liter of Plenvu and 1 Liter of water or tea in preparation for endoscopy and nd will follow the Guidelines for preparation of endoscopy.&#xD;
The only Change from Standard care is that patients will receive Plenvu instead of Movicol.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Plenvu</intervention_name>
    <description>All patients in both Groups will drink will drink 1 Liter of Plenvu and 1 Liter of water or tea in preparation for endoscopy according to endoscopy guidelines</description>
    <arm_group_label>IBD patients</arm_group_label>
    <arm_group_label>Screening patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Screening colonoscopy; IBD; age group 18-75 years&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Suspicion or history of IBD&#xD;
&#xD;
               -  Screening colonoscopy&#xD;
&#xD;
               -  Indication for colonoscopy&#xD;
&#xD;
               -  Age 18-75 years&#xD;
&#xD;
               -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Pregnancy or lactating&#xD;
&#xD;
               -  Lower gastrointestinal bleeding with hemodynamic instability&#xD;
&#xD;
               -  Bowel obstruction&#xD;
&#xD;
               -  ASA &gt;3&#xD;
&#xD;
               -  Not sufficiently corrected anticoagulation disorders&#xD;
&#xD;
               -  Plenvu must not be taken:&#xD;
&#xD;
                    -  if you are allergic (hypersensitive) to the active ingredients or any of the&#xD;
                       other ingredients of this medicine;&#xD;
&#xD;
                    -  if you have a blockage (obstruction) in the digestive tract.&#xD;
&#xD;
                    -  if you have a breakthrough (perforation) in the wall of the digestive tract;&#xD;
&#xD;
                    -  if you suffer from intestinal obstruction (Ileus);&#xD;
&#xD;
                    -  if you suffer from a disturbance of gastric emptying (e.g. gastroparesis,&#xD;
                       gastric retention);&#xD;
&#xD;
                    -  if you suffer from phenylketonuria. Phenylketonuria is a congenital&#xD;
                       metabolic disease in which phenylalanine cannot be processed by your body.&#xD;
                       Plenvu contains aspartame as a source of phenylalanine;&#xD;
&#xD;
                    -  if you suffer from glucose-6-phosphate dehydrogenase deficiency;&#xD;
&#xD;
                    -  if you suffer from acute colon enlargement (toxic megacolon).&#xD;
&#xD;
               -  Warnings and precautions&#xD;
&#xD;
                  o You should tell your doctor about the following circumstances before taking&#xD;
                  Plenvu:&#xD;
&#xD;
               -  if you have heart problems and/or arrhythmias;&#xD;
&#xD;
               -  if you have kidney problems and/or suffer from dehydration;&#xD;
&#xD;
               -  if you have stomach or intestinal problems, including intestinal inflammation;&#xD;
&#xD;
               -  if you have difficulty or discomfort when swallowing liquids;&#xD;
&#xD;
               -  if you have high or low levels of electrolyte (e.g. sodium, potassium);&#xD;
&#xD;
               -  if you have other diseases (e.g. convulsions).&#xD;
&#xD;
               -  Pregnancy and lactation o There are no data on the use of Plenvu during pregnancy&#xD;
                  or lactation and is therefore not recommended.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Helmut Neumann, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Medical Center Mainz</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Helmut Neumann, Prof.</last_name>
    <phone>+491786651595</phone>
    <email>helmut.neumann@unimedizin-mainz.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Tanja Bender, M.A.</last_name>
    <phone>+49613117</phone>
    <phone_ext>6838</phone_ext>
    <email>tanja.bender@unimedizin-mainz.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Dr. Helmut Neumann</name>
      <address>
        <city>Bad Salzuflen</city>
        <state>Northrine-Westfalia</state>
        <zip>32105</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Helmut Neumann, Dr. med.</last_name>
      <phone>+495222</phone>
      <phone_ext>369836</phone_ext>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dr. Horst Hohn</name>
      <address>
        <city>Koblenz</city>
        <state>Rhenanie-Palatinate</state>
        <zip>56068</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Horst Hohn, Dr. med.</last_name>
      <phone>+49261</phone>
      <phone_ext>18553</phone_ext>
      <email>praxis@dr-hohn.de</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University Hospital Mainz</name>
      <address>
        <city>Mainz</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Prof. Helmut Neumann</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>September 3, 2020</last_update_submitted>
  <last_update_submitted_qc>September 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Johannes Gutenberg University Mainz</investigator_affiliation>
    <investigator_full_name>Prof. Helmut Neumann</investigator_full_name>
    <investigator_title>Head of Interdisciplinary Endoscopy</investigator_title>
  </responsible_party>
  <keyword>endoscopy</keyword>
  <keyword>preparation</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Preliminary data 2020 for: DDW 2021 (Deadline Dec. 1st), preliminary data will be available for Norgine for DGVS (Germany) and APDW (Malaysia).&#xD;
Final data: Submission 2021 for DDW, ESGE Days, UEGW, DGVS, APDW&#xD;
Final manuscript: Am J Gastro -&gt; Journal Crohn's Colitis -&gt; Endoscopy -&gt; Gastrointest Endos</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>January 2021-December 2021</ipd_time_frame>
    <ipd_access_criteria>Abstracts and publications</ipd_access_criteria>
  </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/NCT04457934
org study id: 001
secondary id: 125
nct id: NCT04457934
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Patients presenting for endoscopic surveillance of IBD or colorectal screening colonoscopy at
      one of the participating centers will be asked to participate in the present study after
      careful evaluation of inclusion and exclusion criteria. The aim is that the final study
      population will comprise of 50% IBD patients and 50% colorectal cancer screening patients.
      Before inclusion, all patients have to sign the written informed consent. All participating
      patients will receive PLENVU, a well-known and approved bowel preparation agent. Bowel
      preparation is performed following the general recommendations of use. Following the bowel
      preparation, patients are asked if they have well tolerated the preparation, if they already
      had a colonoscopy in the past with another bowel preparation agent and if they would prefer
      PLENVU or another bowel preparation for their next endoscopy examination. Endoscopy is
      performed in standard way and effectiveness of the bowel preparation is specifically
      highlighted by the physician on the documentation report. Finally, data is analyzed regarding
      effectiveness of PLENVU for bowel preparation and patient satisfaction.
PLENVU is effective for bowel preparation and the efficacy and safety of PLENVU has been
      investigated in randomized controlled trials in patients undergoing gut cleansing prior to
      colonoscopy. Data on the specific screening population and for patients suffering from IBD
      however is limited to date. The aim of the current study is to fill this gap and to provide
      data of the effectiveness of PLENVU for the specific patients groups in order to provide
      specific recommendations for an adequate bowel preparation in those groups.

      In general, bowel-preparation in IBD patients is often more challenging. This might be due to
      the chronic disease burden but also according to compliance factors of individual patients.
      Of note, an adequate bowel-preparation is of paramount importance in IBD in order to detect
      subtle neoplasia and to perform chromoendoscopy, which is still recommended by the updated
      ESGE guideline.

      It is anticipated, that PLENVU will help IBD patients to achieve a better bowel preparation,
      thereby yielding in more effective screening colonoscopies and higher acceptance rates of
      patients for surveillance colonoscopies. In order to show that no significant differences are
      seen in the included IBD cohort compared to the general screening population (bias risk), the
      investigators aim to also include patients from the normal screening population.
observational model: Cohort
time perspective: Prospective
measure: Boston Bowel Preparation Standard (BBPS)
time frame: 1 week
description: Bowel preparation according to international Standard (1 is bad, 9 is good), how many BBPs with 9 can be achieved?
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
time frame: 1 day
description: How good will patients tolerate endoscopy and preparation
measure: Number of patients with adverse events
time frame: up to 1 week
description: What Kind of adverse Events can happen during this study
measure: Number of patients who are willing to accept repeated examination (surveillance);
time frame: up to 1 month
description: How many patients will come back for another endoscopy
measure: Adenoma and Polyp Detection Rate (ADR and PDR)
time frame: 1 day
description: How many adenomas and polyps are detected during endoscopy
measure: cecal intubation rate
time frame: 1 day
description: how many endoscopies will reach the ceacum
measure: procedure time
time frame: 3 hours
description: how Long will endoscopy take
arm group label: IBD patients
description: Patients with IBD will undergo preparation for Standard endoscopy with PLENVU, since it is considered to be less affecting for patients. IBD patients have to undergo endoscopy often and mostly suffer from non-efficient preparation.
Patients will drink 1 Liter of Plenvu and 1 Liter of water or tea in preparation for endoscopy and will follow the Guidelines for preparation of endoscopy.
The only Change from Standard care is that patients will receive Plenvu instead of Movicol.
arm group label: Screening patients
description: Screening patients will undergo Standard endoscopy to prevent colon Cancer. Patients will drink 1 Liter of Plenvu and 1 Liter of water or tea in preparation for endoscopy and nd will follow the Guidelines for preparation of endoscopy.
The only Change from Standard care is that patients will receive Plenvu instead of Movicol.
intervention type: Drug
intervention name: Plenvu
description: All patients in both Groups will drink will drink 1 Liter of Plenvu and 1 Liter of water or tea in preparation for endoscopy according to endoscopy guidelines
arm group label: IBD patients
arm group label: Screening patients
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Helmut Neumann, Prof. Dr.
role: Principal Investigator
affiliation: University Medical Center Mainz
last name: Helmut Neumann, Prof.
phone: +491786651595
email: helmut.neumann@unimedizin-mainz.de
last name: Tanja Bender, M.A.
phone: +49613117
phone ext: 6838
email: tanja.bender@unimedizin-mainz.de
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Johannes Gutenberg University Mainz
investigator full name: Prof. Helmut Neumann
investigator title: Head of Interdisciplinary Endoscopy
sharing ipd: Yes
ipd description: Preliminary data 2020 for: DDW 2021 (Deadline Dec. 1st), preliminary data will be available for Norgine for DGVS (Germany) and APDW (Malaysia).
Final data: Submission 2021 for DDW, ESGE Days, UEGW, DGVS, APDW
Final manuscript: Am J Gastro -> Journal Crohn's Colitis -> Endoscopy -> Gastrointest Endos
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd time frame: January 2021-December 2021
ipd access criteria: Abstracts and publications