<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/NCT01714466</url>
  </required_header>
  <id_info>
    <org_study_id>NER1006-01/2012 (OPT)</org_study_id>
    <nct_id>NCT01714466</nct_id>
  </id_info>
  <brief_title>Pharmacodynamic and Clinical Evaluation of Dose and Taste-optimised Low Volume PEG-based Bowel Cleansing Solutions Using the Split-dosing Intake Regimen in Healthy Subjects and in Subjects Undergoing Screening Colonoscopy</brief_title>
  <official_title>Pharmacodynamic and Clinical Evaluation of Dose and Taste-optimised Low Volume PEG-based Bowel Cleansing Solutions Using the Split-dosing Intake Regimen in Healthy Subjects and in Subjects Undergoing Screening Colonoscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Norgine</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Norgine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A study to assess the pharmacodynamics, safety and tolerability of a PEG-based bowel&#xD;
      cleansing solution (MOVIPREP®)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">January 2014</completion_date>
  <primary_completion_date type="Actual">July 2013</primary_completion_date>
  <phase>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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Stool weight output</measure>
    <time_frame>36 hours post-dose</time_frame>
    <description>Stool weight output generated by the IMP from the start of the intake on the evening of Day 1 and the following 24 hours</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cleansing success rate</measure>
    <time_frame>36 hours post-dose</time_frame>
    <description>The cleansing success rate (grade A or B according to the Harefield Cleansing Scale)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tolerability of medication (vomiting rate)</measure>
    <time_frame>36 hours post-dose</time_frame>
    <description>The patient's tolerability to the study medication by measuring their vomiting rate for both parts A and B</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ 5D patient questionnaire outcome (Part A only)</measure>
    <time_frame>36 hours post-dose</time_frame>
    <description>Patients to use the EQ 5D patient questionnaire to assess their study medication for part A</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cleansing scores for each colon segment</measure>
    <time_frame>36 hours post-dose</time_frame>
    <description>The segmental cleansing scores for each of the five colon segments</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time and volume of IMP to reach a clear effluent</measure>
    <time_frame>36 hours post-dose</time_frame>
    <description>The time and volume taken for the IMP to reach a clear effluent</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ascorbate concentration</measure>
    <time_frame>36 hours post-dose</time_frame>
    <description>Concentration of ascorbate components and its metabolites (such as dehydroascorbic acid and oxalic acid)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Electrolytes concentration</measure>
    <time_frame>36 hours post-dose</time_frame>
    <description>Concentration of electrolytes in blood, urine and faeces</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PEG3350 concentration</measure>
    <time_frame>36 hours post-dose</time_frame>
    <description>Presence of PEG3350 in faeces, at defined time points, to demonstrate biological activities</description>
  </secondary_outcome>
  <number_of_arms>8</number_of_arms>
  <enrollment type="Actual">240</enrollment>
  <condition>Colon Cancer</condition>
  <arm_group>
    <arm_group_label>Part A, arm 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Evening dose of TF048. Morning dose of TF043</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part A, arm 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Evening dose of TF043. Morning dose of TF048</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part A, arm 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Evening dose of TF047. Morning dose of TF043</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part A, arm 4</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>MOVIPREP (Both evening and morning dose)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B, arm 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>IMP selected based on the optimal dosing sequence and volume identified from Part A</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B, arm 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>IMP as used in Part B, arm 1, with a differing amount of additional clear fluid being consumed</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B, arm 3</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>IMP as used in Part B, arm 1, except for a reduced amount of ascorbate</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B, arm 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MOVIPREP used in both evening and morning dose</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>NER1006</intervention_name>
    <arm_group_label>Part A, arm 1</arm_group_label>
    <arm_group_label>Part A, arm 2</arm_group_label>
    <arm_group_label>Part A, arm 3</arm_group_label>
    <arm_group_label>Part B, arm 1</arm_group_label>
    <arm_group_label>Part B, arm 2</arm_group_label>
    <arm_group_label>Part B, arm 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MOVIPREP</intervention_name>
    <arm_group_label>Part A, arm 4</arm_group_label>
    <arm_group_label>Part B, arm 4</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The subject's written informed consent must be obtained prior to inclusion.&#xD;
&#xD;
          -  Subjects age 40 to 70 years.&#xD;
&#xD;
          -  Part B only: Subjects willing to undergoing a screening colonoscopy, where the&#xD;
             subject:&#xD;
&#xD;
               1. is between 40 and 70 years of age and has a known personal or familial risk of&#xD;
                  colon neoplasia,or&#xD;
&#xD;
               2. is aged 55 to 70.&#xD;
&#xD;
          -  Part A: Subjects need to be without any history of clinically significant&#xD;
             gastrointestinal symptoms by clinical judgement and without the presence of acute&#xD;
             abdominal discomfort or symptoms.&#xD;
&#xD;
          -  Females of child bearing potential must be surgically sterile, post- menopausal,&#xD;
             practicing true sexual abstinence or using an acceptable form of effective&#xD;
             contraception throughout the study from the following list: contraceptive injections,&#xD;
             implants, oral contraceptives, intrauterine system (IUS), some intrauterine devices&#xD;
             (IUDs), vasectomised partner or barrier method (condom or occlusive cap) with&#xD;
             spermicidal foam/gel/film/cream/suppository. Females using oral contraceptives must&#xD;
             also use additional contraception. Hormonal and IUD methods of contraception must be&#xD;
             established for a period of 3 months prior to dosing and cannot be changed or altered&#xD;
             during the study. All females must have a negative pregnancy test at screening and&#xD;
             check-in (unless post-menopausal).&#xD;
&#xD;
          -  Willing, able and competent to complete the entire procedure and to comply with study&#xD;
             instructions.&#xD;
&#xD;
          -  Ferrous sulphate should be stopped at least one week prior to study medication.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Part A only: Subjects undergoing screening colonoscopy.&#xD;
&#xD;
          -  Presence of current clinically significant functional gastrointestinal (GI) disorder&#xD;
             (e.g. gastric emptying disorder, chronic constipation, irritable bowel syndrome&#xD;
             [IBS]).&#xD;
&#xD;
          -  Regular use of laxatives or colon motility altering drugs in the last month.&#xD;
&#xD;
          -  Donation or loss of 500 mL or more of blood within 8 weeks prior to the first dose of&#xD;
             investigational drug.&#xD;
&#xD;
          -  Any history or current presence of ileus, gastrointestinal (GI) obstruction or&#xD;
             perforation , GI tract cancer, inflammatory bowel disease (IBD) or colonic resection.&#xD;
&#xD;
          -  Known glucose-6-phosphatase dehydrogenase deficiency.&#xD;
&#xD;
          -  Known phenylketonuria.&#xD;
&#xD;
          -  History or evidence of any clinical significant cardiovascular or neurological&#xD;
             disease, cardiac, renal or hepatic insufficiency.&#xD;
&#xD;
          -  Known hypersensitivity to polyethylene glycols and/or ascorbic acid.&#xD;
&#xD;
          -  History or evidence of any clinically relevant electrocardiogram (ECG) abnormalities&#xD;
             and/or uncontrolled hypertension.&#xD;
&#xD;
          -  Evidence of dehydration.&#xD;
&#xD;
          -  Any evidence for clinically significant abnormal sodium or potassium levels or other&#xD;
             clinically significant plasma electrolyte disturbances.&#xD;
&#xD;
          -  Females who are not post-menopausal with a positive pregnancy test. Females not using&#xD;
             reliable methods of birth control if not post-menopausal.&#xD;
&#xD;
          -  Clinically relevant findings on physical examination based on the Investigator's&#xD;
             judgement.&#xD;
&#xD;
          -  Clinically relevant deviations of laboratory parameters from reference ranges at&#xD;
             screening or check-in evaluation.&#xD;
&#xD;
          -  Positive serology for chronic viral hepatitis or human immunodeficiency virus (HIV) at&#xD;
             screening.&#xD;
&#xD;
          -  History of drug or alcohol abuse within the 12 months prior to dosing or evidence of&#xD;
             such abuse as indicated by the laboratory assays conducted during the screening or&#xD;
             check-in evaluations.&#xD;
&#xD;
          -  Subjects who are unwilling to comply with the provisions of the study protocol.&#xD;
&#xD;
          -  Concurrent participation in an investigational drug study or participation within 3&#xD;
             months of study entry.&#xD;
&#xD;
          -  Subject has a condition or is in a situation, which in the Investigator's opinion may&#xD;
             put the subject at significant risk, may confound the study results, or may interfere&#xD;
             significantly.&#xD;
&#xD;
          -  Previous participation in the study.&#xD;
&#xD;
          -  Persons who are ordered to live in an institution on court or authority order&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rudiger Kornberger, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Parexel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>PAREXEL International Early Product Development Unit</name>
      <address>
        <city>Berlin</city>
        <zip>14050</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Parexel International GmbH</name>
      <address>
        <city>Berlin</city>
        <zip>14050</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>October 19, 2012</study_first_submitted>
  <study_first_submitted_qc>October 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 26, 2012</study_first_posted>
  <last_update_submitted>November 19, 2014</last_update_submitted>
  <last_update_submitted_qc>November 19, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 20, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colonic Neoplasms</mesh_term>
  </condition_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/NCT01714466
org study id: NER1006-01/2012 (OPT)
nct id: NCT01714466
lead sponsor: 
has dmc: No
A study to assess the pharmacodynamics, safety and tolerability of a PEG-based bowel
      cleansing solution (MOVIPREP®)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Stool weight output
time frame: 36 hours post-dose
description: Stool weight output generated by the IMP from the start of the intake on the evening of Day 1 and the following 24 hours
measure: Cleansing success rate
time frame: 36 hours post-dose
description: The cleansing success rate (grade A or B according to the Harefield Cleansing Scale)
measure: Tolerability of medication (vomiting rate)
time frame: 36 hours post-dose
description: The patient's tolerability to the study medication by measuring their vomiting rate for both parts A and B
measure: EQ 5D patient questionnaire outcome (Part A only)
time frame: 36 hours post-dose
description: Patients to use the EQ 5D patient questionnaire to assess their study medication for part A
measure: Cleansing scores for each colon segment
time frame: 36 hours post-dose
description: The segmental cleansing scores for each of the five colon segments
measure: Time and volume of IMP to reach a clear effluent
time frame: 36 hours post-dose
description: The time and volume taken for the IMP to reach a clear effluent
measure: Ascorbate concentration
time frame: 36 hours post-dose
description: Concentration of ascorbate components and its metabolites (such as dehydroascorbic acid and oxalic acid)
measure: Electrolytes concentration
time frame: 36 hours post-dose
description: Concentration of electrolytes in blood, urine and faeces
measure: PEG3350 concentration
time frame: 36 hours post-dose
description: Presence of PEG3350 in faeces, at defined time points, to demonstrate biological activities
arm group label: Part A, arm 1
arm group type: Experimental
description: Evening dose of TF048. Morning dose of TF043
arm group label: Part A, arm 2
arm group type: Experimental
description: Evening dose of TF043. Morning dose of TF048
arm group label: Part A, arm 3
arm group type: Experimental
description: Evening dose of TF047. Morning dose of TF043
arm group label: Part A, arm 4
arm group type: Active Comparator
description: MOVIPREP (Both evening and morning dose)
arm group label: Part B, arm 1
arm group type: Experimental
description: IMP selected based on the optimal dosing sequence and volume identified from Part A
arm group label: Part B, arm 2
arm group type: Experimental
description: IMP as used in Part B, arm 1, with a differing amount of additional clear fluid being consumed
arm group label: Part B, arm 3
arm group type: Active Comparator
description: IMP as used in Part B, arm 1, except for a reduced amount of ascorbate
arm group label: Part B, arm 4
arm group type: Experimental
description: MOVIPREP used in both evening and morning dose
intervention type: Drug
intervention name: NER1006
arm group label: Part A, arm 1
arm group label: Part A, arm 2
arm group label: Part A, arm 3
arm group label: Part B, arm 1
arm group label: Part B, arm 2
arm group label: Part B, arm 3
intervention type: Drug
intervention name: MOVIPREP
arm group label: Part A, arm 4
arm group label: Part B, arm 4
criteria: 
gender: All
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Rudiger Kornberger, MD
role: Principal Investigator
affiliation: Parexel
facility: 
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Colonic Neoplasms