<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/NCT01674166</url>
  </required_header>
  <id_info>
    <org_study_id>PRU-USA-12</org_study_id>
    <nct_id>NCT01674166</nct_id>
  </id_info>
  <brief_title>Single Dose Pharmacokinetics of Prucalopride in Paediatric Subjects, With Functional Faecal Retention</brief_title>
  <official_title>A Single-dose Pharmacokinetic Trial of 0.03 mg/kg R108512 Solution in Paediatric Subjects, Aged &gt;= 4 to &lt;= 12 Years With Functional Faecal Retention (FFR).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Movetis</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Movetis</source>
  <brief_summary>
    <textblock>
      The purpose of this study is characterize the pharmacokinetics of a single oral dose of 0.03&#xD;
      mg/kg prucalopride in paediatric subjects aged &gt;= 4 to &lt;= 12 years with functional faecal&#xD;
      retention.&#xD;
&#xD;
      Hypothesis:&#xD;
&#xD;
      Pharmacokinetic profile of prucalopride in paediatric subjects is expected to resemble the&#xD;
      adult pharmacokinetic profile&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multicentre, open-label, single-dose pharmacokinetic trial. A minimum of 24&#xD;
      paediatric subjects (aged ≥ 4 to ≤ 12 years) with functional faecal retention (FFR) were&#xD;
      administered a single dose of prucalopride in oral solution.&#xD;
&#xD;
      All subjects who qualified to enter the trial received a single dose of 0.03 mg/kg&#xD;
      prucalopride oral solution at Hour 0 on Day 1. One blood sample was drawn prior to dosing,&#xD;
      and 13 samples were drawn over the 72-hour interval following the single dose or&#xD;
      prucalopride. Urine was collected quantitatively for the first 24 hours. Plasma prepared from&#xD;
      blood samples and urine samples were assayed for prucalopride concentrations. Safety was&#xD;
      monitored over the 72-hour interval following the dose of trial medication.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 1998</start_date>
  <completion_date type="Actual">May 1999</completion_date>
  <primary_completion_date type="Actual">May 1999</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To characterize the pharmacokinetics of a single oral dose of 0.03 mg/kg prucalopride in paediatric subjects aged &gt;= 4 to &lt;= 12 years with functional faecal retention.</measure>
  </primary_outcome>
  <secondary_outcome>
    <measure>Secondary efficacy variables: safety and tolerability of a single dose of prucalopride 0.03 mg/kg given to paediatric subjects with FFR.</measure>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Constipation</condition>
  <arm_group>
    <arm_group_label>prucalopride</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>single dose 0.03 mg/kg prucalopride open label</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>prucalopride</intervention_name>
    <description>single dose 0.03 mg/kg prucalopride open label</description>
    <arm_group_label>prucalopride</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects with a confirmed diagnosis of FFR, defined as a minimum 2-month history of&#xD;
             faecal impaction, plus at least one of the following:&#xD;
&#xD;
               -  &lt; 3 bowel movements per week at the toilet;&#xD;
&#xD;
               -  A history of soiling;&#xD;
&#xD;
          -  Male and female subjects ≥ 4 to ≤ 12 years of age, with a Tanner stage 1 of 2 or less;&#xD;
&#xD;
          -  Weight-height proportionality for age within the 5th and 95th percentile;&#xD;
&#xD;
          -  Written informed consent, signed by the subject's legal guardian and by the&#xD;
             investigator, and;&#xD;
&#xD;
          -  Subject assent documented in the form of a note-to-file in the subject's source&#xD;
             documentation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Requirement for any medication during the period of the trial;&#xD;
&#xD;
          -  Evidence by examination or laboratory tests of abnormal growth;&#xD;
&#xD;
          -  An abnormal neurologic examination;&#xD;
&#xD;
          -  Cystic fibrosis;&#xD;
&#xD;
          -  History of, or current anorectal malformations;&#xD;
&#xD;
          -  Diagnosed chromosomal abnormalities (e.g., Down's Syndrome);&#xD;
&#xD;
          -  Disease state or surgery known to significantly affect the gastrointestinal absorption&#xD;
             of drugs, or the assessment of the trial drug's effect;&#xD;
&#xD;
          -  Any history, clinical and/or biochemical evidence of clinically significant renal or&#xD;
             liver disease or cirrhosis;&#xD;
&#xD;
          -  Clinically significant anaemia;&#xD;
&#xD;
          -  Use of any investigational drug within the 4-week period prior to administration of&#xD;
             trial medication.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Harald Winter, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital for Children, Boston, Massachusetts, USA</affiliation>
  </overall_official>
  <verification_date>June 2012</verification_date>
  <study_first_submitted>August 24, 2012</study_first_submitted>
  <study_first_submitted_qc>August 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2012</study_first_posted>
  <last_update_submitted>August 27, 2012</last_update_submitted>
  <last_update_submitted_qc>August 27, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 28, 2012</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>Constipation</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prucalopride</mesh_term>
  </intervention_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/NCT01674166
org study id: PRU-USA-12
nct id: NCT01674166
lead sponsor: 
The purpose of this study is characterize the pharmacokinetics of a single oral dose of 0.03
      mg/kg prucalopride in paediatric subjects aged >= 4 to <= 12 years with functional faecal
      retention.

      Hypothesis:

      Pharmacokinetic profile of prucalopride in paediatric subjects is expected to resemble the
      adult pharmacokinetic profile
This is a multicentre, open-label, single-dose pharmacokinetic trial. A minimum of 24
      paediatric subjects (aged ≥ 4 to ≤ 12 years) with functional faecal retention (FFR) were
      administered a single dose of prucalopride in oral solution.

      All subjects who qualified to enter the trial received a single dose of 0.03 mg/kg
      prucalopride oral solution at Hour 0 on Day 1. One blood sample was drawn prior to dosing,
      and 13 samples were drawn over the 72-hour interval following the single dose or
      prucalopride. Urine was collected quantitatively for the first 24 hours. Plasma prepared from
      blood samples and urine samples were assayed for prucalopride concentrations. Safety was
      monitored over the 72-hour interval following the dose of trial medication.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: To characterize the pharmacokinetics of a single oral dose of 0.03 mg/kg prucalopride in paediatric subjects aged >= 4 to <= 12 years with functional faecal retention.
measure: Secondary efficacy variables: safety and tolerability of a single dose of prucalopride 0.03 mg/kg given to paediatric subjects with FFR.
arm group label: prucalopride
arm group type: Experimental
description: single dose 0.03 mg/kg prucalopride open label
intervention type: Drug
intervention name: prucalopride
description: single dose 0.03 mg/kg prucalopride open label
arm group label: prucalopride
criteria: 
gender: All
minimum age: 4 Years
maximum age: 12 Years
last name: Harald Winter, M.D.
role: Principal Investigator
affiliation: Massachusetts General Hospital for Children, Boston, Massachusetts, USA
responsible party type: Sponsor
mesh term: Constipation
mesh term: Prucalopride