<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/NCT01715272</url>
  </required_header>
  <id_info>
    <org_study_id>NER1008-01/2012 (DBC)</org_study_id>
    <nct_id>NCT01715272</nct_id>
  </id_info>
  <brief_title>A Clinical Investigation to Demonstrate the Performance of a New Enema (TF037) in Distal Bowel Cleansing Compared With Fleet Enema</brief_title>
  <official_title>A Clinical Investigation to Demonstrate the Performance of a New Enema (TF037) in Distal Bowel Cleansing Compared With Fleet Enema</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>
      This study is designed to assess the difference between the performance of a new enema&#xD;
      (TF037) against Fleet enema in distal bowel cleansing.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">January 2013</completion_date>
  <primary_completion_date type="Actual">December 2012</primary_completion_date>
  <phase>Phase 1</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>Single (Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Performance of TF037 in distal bowel cleansing compared to Fleet enema using the Harefield Cleansing scale</measure>
    <time_frame>Between 1 to 3 hours following enema administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Stool output as measured by stool weight</measure>
    <time_frame>up to 1 hour following enema administration</time_frame>
    <description>To compare the stool output (as measured as stool weight) during the 1 hour period following enema administration for TF037 and Fleet enema</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety and tolerability as assessed by use of a Visual Analogue scale (VAS)</measure>
    <time_frame>5 and 30 minutes following enema administration</time_frame>
    <description>To assess the safety (including effects on water homeostasis) and tolerability of this medical device in its intended purpose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stool output over time</measure>
    <time_frame>1 hour following enema administration</time_frame>
    <description>To assess kinetics of bowel movements in relation to stool output over time</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Colonoscopy</condition>
  <arm_group>
    <arm_group_label>Fleet enema</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group will receive Fleet enema as their treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TF037</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will receive TF037 as their treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TF037</intervention_name>
    <arm_group_label>TF037</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fleet enema</intervention_name>
    <arm_group_label>Fleet enema</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male or female subjects [as determined by medical history, physical&#xD;
             examination, laboratory test values, vital signs and 12-lead electrocardiograms (ECGs)&#xD;
             at screening] aged 18 to 60 years.&#xD;
&#xD;
          -  Non-smokers from 3 months before enema administration and for the duration of the&#xD;
             clinical investigation.&#xD;
&#xD;
          -  Body mass index (BMI) ≥ 18 and ≤ 35 kg/m2.&#xD;
&#xD;
          -  Must voluntarily provide written informed consent to participate in the clinical&#xD;
             investigation.&#xD;
&#xD;
          -  Must understand the purposes and risks of the clinical investigation and agree to&#xD;
             follow the restrictions and schedule of procedures as defined in the clinical&#xD;
             investigation plan, and as confirmed during the informed consent process.&#xD;
&#xD;
          -  Female subjects must be postmenopausal (for at least one year and confirmed by a serum&#xD;
             follicle stimulating hormone (FSH) test at screening), surgically sterile, practising&#xD;
             true sexual abstinence or must use an effective method of contraception.&#xD;
&#xD;
          -  Female subjects of child-bearing potential must have a negative serum pregnancy test&#xD;
             at screening and a negative urine pregnancy test at check-in of each period.&#xD;
&#xD;
          -  The subject's primary care physician must confirm that there is nothing in their&#xD;
             medical history that would preclude their enrolment into this clinical investigation.&#xD;
&#xD;
          -  Must be willing to consent to have data entered into The Over Volunteering Prevention&#xD;
             System (TOPS).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with a history or presence of significant cardiovascular disease, pulmonary,&#xD;
             hepatic, gallbladder or biliary tract, renal, haematologic, gastrointestinal,&#xD;
             endocrine, immunologic, dermatologic, neurologic or psychiatric disease.&#xD;
&#xD;
          -  Subjects with a history or presence of organic or functional gastrointestinal&#xD;
             conditions (e.g. chronic constipation, irritable bowel syndrome, inflammatory bowel&#xD;
             disease).&#xD;
&#xD;
          -  Subjects with a clinically relevant history or presence of abnormal gastrointestinal&#xD;
             motility.&#xD;
&#xD;
          -  Subjects with a significant history of hereditary bowel disorders.&#xD;
&#xD;
          -  Subjects with abnormal findings on the digital rectal examination performed at&#xD;
             screening.&#xD;
&#xD;
          -  Use of laxatives or motility altering drugs in the 3 months preceding enema&#xD;
             administration.&#xD;
&#xD;
          -  Use of any prescription or over-the-counter medication (including vitamins, herbal and&#xD;
             mineral supplements) within 14 days prior to enema administration (or within 5 half&#xD;
             lives if longer), with the exception of Investigator-approved hormonal contraceptives,&#xD;
             hormone replacement therapy (HRT) and occasional paracetamol, aspirin or ibuprofen.&#xD;
&#xD;
          -  Participation in a clinical drug study during the 30 days preceding enema&#xD;
             administration in this clinical investigation.&#xD;
&#xD;
          -  Donation of blood or blood products within 30 days prior to enema administration or&#xD;
             during the clinical investigation, except as required for this clinical investigation&#xD;
&#xD;
          -  Pregnant or lactating females.&#xD;
&#xD;
          -  Any clinically significant illness within 28 days prior to enema administration.&#xD;
&#xD;
          -  History or presence of any significant drug allergy, or a known allergy or&#xD;
             contraindication to trisodium citrate, Fleet® enema or midazolam.&#xD;
&#xD;
          -  Laboratory values at screening which are deemed to be clinically significant, unless&#xD;
             agreed in advance by the Sponsor's Medical Representative and Principal Investigator.&#xD;
&#xD;
          -  Positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C.&#xD;
&#xD;
          -  Current or history of drug or alcohol abuse within the 12 months prior to enema&#xD;
             administration, or a positive drugs of abuse test at screening or check-in.&#xD;
&#xD;
          -  Consumption of alcoholic beverages within 24 hours of check-inor during confinement.&#xD;
&#xD;
          -  Subjects who, in the opinion of the Investigator, are unsuitable for participation in&#xD;
             the clinical investigation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ronnie Beboso, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>BioKinetic Europe Ltd.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>BioKinetic Europe Ltd</name>
      <address>
        <city>Belfast</city>
        <state>Northern Ireland</state>
        <zip>BT2 7BA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BioKinetic Europe Ltd</name>
      <address>
        <city>Belfast</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>February 2013</verification_date>
  <study_first_submitted>October 24, 2012</study_first_submitted>
  <study_first_submitted_qc>October 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 26, 2012</study_first_posted>
  <last_update_submitted>February 27, 2013</last_update_submitted>
  <last_update_submitted_qc>February 27, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 28, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT01715272
org study id: NER1008-01/2012 (DBC)
nct id: NCT01715272
lead sponsor: 
has dmc: No
This study is designed to assess the difference between the performance of a new enema
      (TF037) against Fleet enema in distal bowel cleansing.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Care Provider)
measure: Performance of TF037 in distal bowel cleansing compared to Fleet enema using the Harefield Cleansing scale
time frame: Between 1 to 3 hours following enema administration
measure: Stool output as measured by stool weight
time frame: up to 1 hour following enema administration
description: To compare the stool output (as measured as stool weight) during the 1 hour period following enema administration for TF037 and Fleet enema
measure: Safety and tolerability as assessed by use of a Visual Analogue scale (VAS)
time frame: 5 and 30 minutes following enema administration
description: To assess the safety (including effects on water homeostasis) and tolerability of this medical device in its intended purpose
measure: Stool output over time
time frame: 1 hour following enema administration
description: To assess kinetics of bowel movements in relation to stool output over time
arm group label: Fleet enema
arm group type: Active Comparator
description: This group will receive Fleet enema as their treatment
arm group label: TF037
arm group type: Experimental
description: This group will receive TF037 as their treatment
intervention type: Device
intervention name: TF037
arm group label: TF037
intervention type: Drug
intervention name: Fleet enema
arm group label: Fleet enema
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ronnie Beboso, MD
role: Principal Investigator
affiliation: BioKinetic Europe Ltd.
facility: 
facility: 
country: United Kingdom
responsible party type: Sponsor