<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/NCT01670669</url>
  </required_header>
  <id_info>
    <org_study_id>PRU-USA-24</org_study_id>
    <nct_id>NCT01670669</nct_id>
  </id_info>
  <brief_title>Prucalopride in Paediatric Subjects, With Functional Faecal Retention</brief_title>
  <official_title>An Open-label Follow-up Study of 0.01 mg/kg/Day to 0.03 mg/kg/Day Prucalopride (R108512) Oral Solution in Paediatric Subjects, Aged &gt;= 4 to &lt;= 12 Years With Functional Faecal Retention (FFR), Who Participated in the PRU-USA-12.</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 efficacy, safety, tolerability, and&#xD;
      steady-state plasma levels after once-daily oral dosing of prucalopride (R108512) as a&#xD;
      solution, 0.01 mg/kg to 0.03 mg/kg, given to paediatric subjects with functional faecal&#xD;
      retention (FFR) for 8 weeks.&#xD;
&#xD;
      Hypothesis:&#xD;
&#xD;
      Pharmacokinetic profile of prucalopride in paediatric subjects is expected to resemble the&#xD;
      adult pharmacokinetic profile. Safety and tolerability profile are expected to resemble the&#xD;
      adult profile.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multicentre, open-label trial in which paediatric subjects (ages 4 to 12 years)&#xD;
      with FFR were administered prucalopride in oral solution once daily for 8 weeks. Subjects who&#xD;
      entered this extension trial had completed PRU-USA-12, a single-dose pharmacokinetic trial,&#xD;
      usually within the previous week.&#xD;
&#xD;
      Evaluations for efficacy, safety and tolerability were performed, and plasma samples for&#xD;
      analysis of prucalopride levels were obtained at 2, 4, 6 and 8 weeks.&#xD;
&#xD;
      The initial dosage of prucalopride oral solution was 0.02 mg/kg/day. Dependent on the&#xD;
      subject's response, the parent could adjust the dosage within a range of 0.01 mg/kg/day to&#xD;
      0.03 mg/kg/day.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 1998</start_date>
  <completion_date type="Actual">July 1999</completion_date>
  <primary_completion_date type="Actual">July 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>Adverse events</measure>
    <description>Adverse events (AEs) to be recorded by spontanous reporting or after non-leading questioning i.e. reporting of all AEs and its duration during the course of the trial. In addition at bi-weekly visits laboratory assessments, vitals signs, ECGs and physical examinations, reported as mean values and clinical significant abnormalities to be tabulated.&#xD;
Efficacy: reporting of bowel movements and its characteristics in a diary.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Efficacy</measure>
    <description>Reporting of bowel movement frequency, i.e. average number of bowel movements on a weekly base.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Secondary efficacy variables: steady-state plasma levels after once-daily oral dosing of prucalopride (R108512) as a solution, 0.01 mg/kg to 0.03 mg/kg, given to paediatric subjects with functional faecal retention (FFR) for 8 weeks.</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>Constipation</condition>
  <arm_group>
    <arm_group_label>prucalopride</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>0.01 mg/kg/day to 0.03 mg/kg/day prucalopride (R108512) oral solution</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>prucalopride</intervention_name>
    <description>0.01 mg/kg/day to 0.03 mg/kg/day prucalopride (R108512) oral solution</description>
    <arm_group_label>prucalopride</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject completed the PRU-USA-12 pharmacokinetic trial&#xD;
&#xD;
          -  Subject bowels had been &quot;cleaned-out&quot; (ie, any faecal impactions removed)&#xD;
&#xD;
          -  Written informed consent, signed by the subject's legal guardian and by the&#xD;
             investigator&#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;
        • No exclusion criteria&#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>August 2012</verification_date>
  <study_first_submitted>July 31, 2012</study_first_submitted>
  <study_first_submitted_qc>August 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2012</study_first_posted>
  <last_update_submitted>August 20, 2012</last_update_submitted>
  <last_update_submitted_qc>August 20, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 22, 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/NCT01670669
org study id: PRU-USA-24
nct id: NCT01670669
lead sponsor: 
The purpose of this study is characterize the efficacy, safety, tolerability, and
      steady-state plasma levels after once-daily oral dosing of prucalopride (R108512) as a
      solution, 0.01 mg/kg to 0.03 mg/kg, given to paediatric subjects with functional faecal
      retention (FFR) for 8 weeks.

      Hypothesis:

      Pharmacokinetic profile of prucalopride in paediatric subjects is expected to resemble the
      adult pharmacokinetic profile. Safety and tolerability profile are expected to resemble the
      adult profile.
This is a multicentre, open-label trial in which paediatric subjects (ages 4 to 12 years)
      with FFR were administered prucalopride in oral solution once daily for 8 weeks. Subjects who
      entered this extension trial had completed PRU-USA-12, a single-dose pharmacokinetic trial,
      usually within the previous week.

      Evaluations for efficacy, safety and tolerability were performed, and plasma samples for
      analysis of prucalopride levels were obtained at 2, 4, 6 and 8 weeks.

      The initial dosage of prucalopride oral solution was 0.02 mg/kg/day. Dependent on the
      subject's response, the parent could adjust the dosage within a range of 0.01 mg/kg/day to
      0.03 mg/kg/day.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Adverse events
description: Adverse events (AEs) to be recorded by spontanous reporting or after non-leading questioning i.e. reporting of all AEs and its duration during the course of the trial. In addition at bi-weekly visits laboratory assessments, vitals signs, ECGs and physical examinations, reported as mean values and clinical significant abnormalities to be tabulated.
Efficacy: reporting of bowel movements and its characteristics in a diary.
measure: Efficacy
description: Reporting of bowel movement frequency, i.e. average number of bowel movements on a weekly base.
measure: Secondary efficacy variables: steady-state plasma levels after once-daily oral dosing of prucalopride (R108512) as a solution, 0.01 mg/kg to 0.03 mg/kg, given to paediatric subjects with functional faecal retention (FFR) for 8 weeks.
time frame: 8 weeks
arm group label: prucalopride
arm group type: Active Comparator
description: 0.01 mg/kg/day to 0.03 mg/kg/day prucalopride (R108512) oral solution
intervention type: Drug
intervention name: prucalopride
description: 0.01 mg/kg/day to 0.03 mg/kg/day prucalopride (R108512) oral solution
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