<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/NCT01692132</url>
  </required_header>
  <id_info>
    <org_study_id>CR017521</org_study_id>
    <secondary_id>PRUCOP4001</secondary_id>
    <nct_id>NCT01692132</nct_id>
  </id_info>
  <brief_title>A Post Marketing Surveillance Study on the Safety and Effectiveness of Prucalopride in the Treatment of Chronic Constipation</brief_title>
  <official_title>A Study on the Safety and Effectiveness of Prucalopride in the Treatment of Chronic Constipation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen Pharmaceutica</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen Pharmaceutica</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the safety and effectiveness of prucalopride in the&#xD;
      treatment of Filipino patients with chronic constipation whom prior laxatives fail to provide&#xD;
      adequate relief.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a 12-week open label (all people know the identity of the intervention),&#xD;
      multi-center, prospective (the patients are identified and then followed forward in time for&#xD;
      the outcome of the study) observational study assessing the safety and effectiveness of&#xD;
      prucalopride among Filipino patients with chronic constipation. Chronic constipation is a&#xD;
      condition in which bowel movements are infrequent or incomplete for a prolonged time. The use&#xD;
      of prucalopride should be used in accordance with the approved product label and will follow&#xD;
      the normal medical practice of the investigators. Patients should take 2 mg prucalopride&#xD;
      tablet orally once daily. For elderly patients (&gt;65 years old), patients with renal&#xD;
      impairment not requiring dialysis or patients with severe hepatic impairment, 1mg&#xD;
      prucalopride once daily should be given. Patients will be asked to fill-up a patient diary&#xD;
      daily for 12-weeks to monitor the bowel movement during the study period. All adverse events&#xD;
      and concomitant medications taken by the patients during the study will be documented&#xD;
      accordingly. Patients will be monitored during the 12-week period of observation while the&#xD;
      patients are in prucalopride treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    The company decided to cancel this study in conformity with PH FDA Circular 2013-004&#xD;
  </why_stopped>
  <start_date>February 2013</start_date>
  <completion_date type="Anticipated">December 2014</completion_date>
  <primary_completion_date type="Anticipated">February 2014</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>The incidence of patients discontinuing treatment due to adverse events, serious adverse events, or adverse drug reactions</measure>
    <time_frame>12 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The percentage of patients having at least 3 spontaneous complete bowel movements (SCBM) in a week after treatment with prucalopride</measure>
    <time_frame>12 weeks</time_frame>
    <description>SCBM is defined as a sense of complete evacuation of bowel without straining.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change from baseline in the Patient Assessment of Constipation Symptoms (PAC-SYM) score after treatment with prucalopride</measure>
    <time_frame>Baseline, 12 weeks</time_frame>
    <description>The PAC-SYM questionnaire is a 12-item survey that measures constipation symptoms and associated severity across three domains: stool symptoms, rectal symptoms, and abdominal symptoms. Symptom items are rated on a 5-point Likert severity scale. Item values are scored from 0 to 4, with 0 indicating absence of symptom, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe indicating the worst severity of that symptom.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Chronic Constipation</condition>
  <arm_group>
    <arm_group_label>Prucalopride</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prucalopride</intervention_name>
    <description>Prucalopride 2 mg tablet/day orally for 12 weeks. For elderly patients (&gt;65 years old), patients with renal impairment not requiring dialysis or patients with severe hepatic impairment, 1mg prucalopride once daily should be given.</description>
    <arm_group_label>Prucalopride</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Filipino patients with chronic constipation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of chronic constipation by history and physical examination, including&#xD;
             rectal exam&#xD;
&#xD;
          -  History of chronic constipation not satisfied with laxatives&#xD;
&#xD;
          -  Patient reports, on average, 2 or fewer spontaneous bowel movements (SBMs) per week&#xD;
             and 1 or more of the following for the last three months: very hard (little balls)&#xD;
             and/or hard stools in more than 25% of bowel movements (BMs); sensation of incomplete&#xD;
             evacuation in more than 25% of BMs; straining at defecation in more than 25% of BMs;&#xD;
             sensation of ano-rectal obstruction or blockade in more than 25% of BMs; a need for&#xD;
             digital manipulation to facilitate evacuation in more than 25% of BMs&#xD;
&#xD;
          -  Females of childbearing potential agree to use highly effective contraceptive methods&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Renal impairment requiring dialysis&#xD;
&#xD;
          -  Secondary chronic constipation and organic gastrointestinal (GI) disorders&#xD;
&#xD;
          -  Intestinal perforation / obstruction due to structural or functional disorder of the&#xD;
             gut wall, obstructive ileus, severe inflammatory condition of the intestinal tract&#xD;
             such as Crohn's disease, ulcerative colitis, toxic megacolon / rectum&#xD;
&#xD;
          -  Hypersensitive to Prucalopride or to any of its components&#xD;
&#xD;
          -  Patients receiving concomitant drugs known to cause QTc prolongation&#xD;
&#xD;
          -  Pregnant or lactating&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janssen Pharmaceutica Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen Pharmaceutica</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Makati City</city>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Manila</city>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Marikina City</city>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Muntinlupa</city>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Quezon City</city>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Juan</city>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Taguig</city>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Philippines</country>
  </location_countries>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>September 20, 2012</study_first_submitted>
  <study_first_submitted_qc>September 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2012</study_first_posted>
  <last_update_submitted>November 30, 2015</last_update_submitted>
  <last_update_submitted_qc>November 30, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 2, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic Constipation</keyword>
  <keyword>Prucalopride</keyword>
  <keyword>Post Marketing Surveillance</keyword>
  <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/NCT01692132
org study id: CR017521
secondary id: PRUCOP4001
nct id: NCT01692132
lead sponsor: 
has dmc: No
The purpose of this study is to determine the safety and effectiveness of prucalopride in the
      treatment of Filipino patients with chronic constipation whom prior laxatives fail to provide
      adequate relief.
This is a 12-week open label (all people know the identity of the intervention),
      multi-center, prospective (the patients are identified and then followed forward in time for
      the outcome of the study) observational study assessing the safety and effectiveness of
      prucalopride among Filipino patients with chronic constipation. Chronic constipation is a
      condition in which bowel movements are infrequent or incomplete for a prolonged time. The use
      of prucalopride should be used in accordance with the approved product label and will follow
      the normal medical practice of the investigators. Patients should take 2 mg prucalopride
      tablet orally once daily. For elderly patients (>65 years old), patients with renal
      impairment not requiring dialysis or patients with severe hepatic impairment, 1mg
      prucalopride once daily should be given. Patients will be asked to fill-up a patient diary
      daily for 12-weeks to monitor the bowel movement during the study period. All adverse events
      and concomitant medications taken by the patients during the study will be documented
      accordingly. Patients will be monitored during the 12-week period of observation while the
      patients are in prucalopride treatment.
observational model: Cohort
time perspective: Prospective
measure: The incidence of patients discontinuing treatment due to adverse events, serious adverse events, or adverse drug reactions
time frame: 12 weeks
measure: The percentage of patients having at least 3 spontaneous complete bowel movements (SCBM) in a week after treatment with prucalopride
time frame: 12 weeks
description: SCBM is defined as a sense of complete evacuation of bowel without straining.
measure: The change from baseline in the Patient Assessment of Constipation Symptoms (PAC-SYM) score after treatment with prucalopride
time frame: Baseline, 12 weeks
description: The PAC-SYM questionnaire is a 12-item survey that measures constipation symptoms and associated severity across three domains: stool symptoms, rectal symptoms, and abdominal symptoms. Symptom items are rated on a 5-point Likert severity scale. Item values are scored from 0 to 4, with 0 indicating absence of symptom, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe indicating the worst severity of that symptom.
arm group label: Prucalopride
intervention type: Drug
intervention name: Prucalopride
description: Prucalopride 2 mg tablet/day orally for 12 weeks. For elderly patients (>65 years old), patients with renal impairment not requiring dialysis or patients with severe hepatic impairment, 1mg prucalopride once daily should be given.
arm group label: Prucalopride
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Janssen Pharmaceutica Clinical Trial
role: Study Director
affiliation: Janssen Pharmaceutica
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Philippines
responsible party type: Sponsor
mesh term: Constipation
mesh term: Prucalopride