<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/NCT02228616</url>
  </required_header>
  <id_info>
    <org_study_id>CR102381</org_study_id>
    <secondary_id>PRUCOP4005</secondary_id>
    <secondary_id>PRU-C-13-CN-004-V02</secondary_id>
    <nct_id>NCT02228616</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Prucalopride in Combination With Polyethylene Glycol or Lactulose in Women With Chronic Constipation</brief_title>
  <official_title>A Multicenter, Single-Arm, Interventional, Phase 4 Study to Evaluate the Efficacy and Safety of Prucalopride in Combination With PEG or Lactulose in Women With Chronic Constipation (CC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xian-Janssen Pharmaceutical Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Xian-Janssen Pharmaceutical Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the efficacy of prucalopride 2 mg, given orally once&#xD;
      daily for 12 weeks, in combination with PEG or lactulose, in treatment of women with Chronic&#xD;
      Constipation (CC) in whom laxatives fail to provide adequate relief, as measured by the&#xD;
      percentage of subjects with a weekly average increase of 1 or more spontaneous complete bowel&#xD;
      movements (SCBMs) (responders) during the 12-week treatment phase as compared to the&#xD;
      baseline.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multicenter, open-labeled, single-arm, interventional study to evaluate the&#xD;
      efficacy and safety of prucalopride in real clinical practice.&#xD;
&#xD;
      It consists of 2 phases: a 1-week run-in phase, a 12 week, open-label treatment phase. Study&#xD;
      population is women with CC who have been treated with laxatives but failed to obtain&#xD;
      adequate relief within the preceding 6 months. Patients who meet the inclusive and without&#xD;
      exclusive criteria will be enrolled in the study and signed an Informed Consent Form. They&#xD;
      are instructed not to change their diet, lifestyle during the study.&#xD;
&#xD;
      At the first week of the study, subjects will continue PEG or lactulose treatment, and they&#xD;
      will not be allowed to use any other laxatives and drugs for CC. Subjects will be required to&#xD;
      maintain a written stool diary as well as the use of PEG and lactulose. Any drug affecting&#xD;
      the colonic motility will be prohibited during the study. Following this run-in phase,&#xD;
      subjects enter the 12-week open-label treatment phase. During the treatment phase, subjects&#xD;
      will be treated for 12 weeks with prucalopride 2 mg, given orally once daily with or without&#xD;
      breakfast in the morning. Subjects will be required to continue PEG or lactulose treatment&#xD;
      with the same dosage as that in the run-in period. If necessary, due to intolerable side&#xD;
      effects (ie, severe diarrhea,), dosage decrements of PEG or lactulose treatment may be made&#xD;
      at any time or the subject could discontinue the PEG or lactulose treatment, based on&#xD;
      investigator's judgement. Subjects will record study drug and laxative medication dosing&#xD;
      information and information related to BMs in a daily diary throughout the study. PAC-SYM and&#xD;
      PAC QOL questionnaires will be completed at Weeks 0, 4, 12. Subject safety will be monitored&#xD;
      throughout the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 14, 2014</start_date>
  <completion_date type="Actual">September 28, 2016</completion_date>
  <primary_completion_date type="Actual">September 28, 2016</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <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>Percentage of subjects with a weekly average increase of 1 or more Spontaneous Complete Bowel Movement (SCBM) during the 12-week treatment phase as compared to the baseline</measure>
    <time_frame>12 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of subjects with a weekly 3 or more Spontaneous Complete Bowel Movement (SCBM) during the 12-week treatment phase as compared to the baseline</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of subjects with a weekly average increase of 1 or more Spontaneous Complete Bowel Movement (SCBM) during the first 4 weeks treatment phase as compared to the baseline</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of subjects with a weekly average increase of 1 or more Spontaneous Bowel Movement (SBM), Bowel Movement (BM) during the 12-week treatment phase as compared to the baseline</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average number of Spontaneous Complete Bowel Movement (SCBM) per week</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average number of SBMs per week</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average number of all BMs per week</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of BMs with normal consistency (Types 3-4 based on Bristol Stool Scale) per week</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average weekly change of PEG or lactulose frequency and dosage as compared to baseline during the 12-week treatment phase</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement of constipation symptoms and higher satisfaction as measured by subject's global assessments and PAC-SYM scores. Improvement is defined as that the mean score reduction from baseline is ≥0.2</measure>
    <time_frame>Baseline, 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in physical, psychological, and emotional stress as measured by PAC QOL scores. Improvement is defined as that the mean score reduction from baseline is ≥0.3</measure>
    <time_frame>Baseline, 12 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">280</enrollment>
  <condition>Constipation</condition>
  <arm_group>
    <arm_group_label>Prucalopride plus Polyethylene glycol or lactulose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prucalopride</intervention_name>
    <description>During the 12-week treatment phase of the study, the daily dose of 1 tablet of 2-mg prucalopride will be administrated orally before breakfast.</description>
    <arm_group_label>Prucalopride plus Polyethylene glycol or lactulose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Polyethylene glycol (PEG)</intervention_name>
    <description>Optimized dose of PEG will be administrated for 13 weeks (1 week run-in+12 weeks intervention).</description>
    <arm_group_label>Prucalopride plus Polyethylene glycol or lactulose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lactulose</intervention_name>
    <description>Optimized dose of Lactulose will be administrated for 13 weeks (1 week run-in+12 weeks intervention).</description>
    <arm_group_label>Prucalopride plus Polyethylene glycol or lactulose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Inclusion criteria for screening phase:&#xD;
&#xD;
          -  Women aged 18 to 65 years, inclusive&#xD;
&#xD;
          -  History of chronic constipation (CC): The subject reports, a weekly average of 2 or&#xD;
             fewer spontaneous bowel movement (SBMs) and 1 or more of the following within the&#xD;
             preceding 3 months before the screening visit, while symptom onset was more than 6&#xD;
             months before the screening visit: 1. very hard (little balls) and/or hard stools in&#xD;
             more than 25% of BMs; 2. sensation of incomplete evacuation in more than 25% of BMs;&#xD;
             3. straining at defecation in more than 25% of BMs; 4. sensation of a no-rectal&#xD;
             obstruction or blockade in more than 25% of BMs; 5. A need for digital manipulation to&#xD;
             facilitate evacuation in more than 25% of BMs&#xD;
&#xD;
          -  Subjects who has been using PEG or lactulose treatment for more than 1 week at&#xD;
             screening&#xD;
&#xD;
          -  Be a non-pregnant, non-lactating woman. Sexually active women must be post menopausal,&#xD;
             surgically sterile, or practicing an effective method of birth control (eg,&#xD;
             prescription oral contraceptives, contraceptive injections, intrauterine device,&#xD;
             double barrier method, contraceptive patch, male partner sterilization) before entry&#xD;
             and throughout the study. Women must have a negative serum beta-human chorionic&#xD;
             gonadotropin pregnancy test at screening and a negative urine pregnancy test&#xD;
             immediately prior to study drug titration&#xD;
&#xD;
          -  Inclusion Criteria for treatment phase: At Visit 2 (Week 0), the diary of Week -1 will&#xD;
             be collected and examined for the presence of chronic constipation. The subject will&#xD;
             be considered eligible for treatment phase if the following criteria are met: Number&#xD;
             of SCBMs is 2 or fewer during the run-in phase (1 week)&#xD;
&#xD;
          -  Subject had NO SBMs during the run-in phase is considered to be constipated&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Potential subjects who meet any of the following criteria will be excluded from&#xD;
             participating in the study&#xD;
&#xD;
          -  Subjects in whom constipation is thought to be drug-induced&#xD;
&#xD;
          -  Subjects suffering from secondary causes of CC&#xD;
&#xD;
          -  Use of or intent to use disallowed medications that influence the bowel habit during&#xD;
             the study (ie, anticholinergics [not including antihistamines], opioids, spasmolytics,&#xD;
             prokinetics, and tricyclic antidepressants)&#xD;
&#xD;
          -  Subjects with severe and clinically uncontrolled cardiovascular, liver, or lung&#xD;
             disease, neurologic or psychiatric disorders (including active alcohol or drug abuse),&#xD;
             cancer or acquired immune deficiency syndrome (AIDS), or other gastrointestinal or&#xD;
             endocrine disorders&#xD;
&#xD;
          -  Subjects with impaired renal function, i.e., serum creatinine &gt;2&#xD;
             milligram/deciliter(&gt;180 micromole/Liter)&#xD;
&#xD;
          -  Subjects with clinically significant abnormalities of hematology, urinalysis, or blood&#xD;
             chemistry&#xD;
&#xD;
          -  Known allergies, hypersensitivity, or intolerance to prucalopride or its excipients&#xD;
&#xD;
          -  Women who are pregnant or breast-feeding&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xian-Janssen Pharmaceutical Ltd., China Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Xian-Janssen Pharmaceutical Ltd.</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bin Zhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chongqing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hangzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nanjing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tianjin</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Wuhan</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Zhengzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <link>
    <url>http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_7051&amp;studyid=5049&amp;filename=CR102381_CSR.pdf</url>
    <description>A Multicenter, Single-Arm, Interventional, Phase 4 Study to Evaluate the Efficacy and Safety of Prucalopride in Combination With PEG or Lactulose in Women With Chronic Constipation (CC)</description>
  </link>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 26, 2014</study_first_submitted>
  <study_first_submitted_qc>August 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2014</study_first_posted>
  <last_update_submitted>September 14, 2017</last_update_submitted>
  <last_update_submitted_qc>September 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 15, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Constipation</keyword>
  <keyword>Chronic constipation</keyword>
  <keyword>Prucalopride</keyword>
  <keyword>Women</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>Lactulose</mesh_term>
    <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/NCT02228616
org study id: CR102381
secondary id: PRUCOP4005
secondary id: PRU-C-13-CN-004-V02
nct id: NCT02228616
lead sponsor: 
has dmc: No
is fda regulated device: No
The purpose of this study is to evaluate the efficacy of prucalopride 2 mg, given orally once
      daily for 12 weeks, in combination with PEG or lactulose, in treatment of women with Chronic
      Constipation (CC) in whom laxatives fail to provide adequate relief, as measured by the
      percentage of subjects with a weekly average increase of 1 or more spontaneous complete bowel
      movements (SCBMs) (responders) during the 12-week treatment phase as compared to the
      baseline.
This is a multicenter, open-labeled, single-arm, interventional study to evaluate the
      efficacy and safety of prucalopride in real clinical practice.

      It consists of 2 phases: a 1-week run-in phase, a 12 week, open-label treatment phase. Study
      population is women with CC who have been treated with laxatives but failed to obtain
      adequate relief within the preceding 6 months. Patients who meet the inclusive and without
      exclusive criteria will be enrolled in the study and signed an Informed Consent Form. They
      are instructed not to change their diet, lifestyle during the study.

      At the first week of the study, subjects will continue PEG or lactulose treatment, and they
      will not be allowed to use any other laxatives and drugs for CC. Subjects will be required to
      maintain a written stool diary as well as the use of PEG and lactulose. Any drug affecting
      the colonic motility will be prohibited during the study. Following this run-in phase,
      subjects enter the 12-week open-label treatment phase. During the treatment phase, subjects
      will be treated for 12 weeks with prucalopride 2 mg, given orally once daily with or without
      breakfast in the morning. Subjects will be required to continue PEG or lactulose treatment
      with the same dosage as that in the run-in period. If necessary, due to intolerable side
      effects (ie, severe diarrhea,), dosage decrements of PEG or lactulose treatment may be made
      at any time or the subject could discontinue the PEG or lactulose treatment, based on
      investigator's judgement. Subjects will record study drug and laxative medication dosing
      information and information related to BMs in a daily diary throughout the study. PAC-SYM and
      PAC QOL questionnaires will be completed at Weeks 0, 4, 12. Subject safety will be monitored
      throughout the study.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of subjects with a weekly average increase of 1 or more Spontaneous Complete Bowel Movement (SCBM) during the 12-week treatment phase as compared to the baseline
time frame: 12 weeks
measure: Percentage of subjects with a weekly 3 or more Spontaneous Complete Bowel Movement (SCBM) during the 12-week treatment phase as compared to the baseline
time frame: 12 weeks
measure: Percentage of subjects with a weekly average increase of 1 or more Spontaneous Complete Bowel Movement (SCBM) during the first 4 weeks treatment phase as compared to the baseline
time frame: 4 weeks
measure: Percentage of subjects with a weekly average increase of 1 or more Spontaneous Bowel Movement (SBM), Bowel Movement (BM) during the 12-week treatment phase as compared to the baseline
time frame: 12 weeks
measure: Average number of Spontaneous Complete Bowel Movement (SCBM) per week
time frame: 12 weeks
measure: Average number of SBMs per week
time frame: 12 weeks
measure: Average number of all BMs per week
time frame: 12 weeks
measure: Percentage of BMs with normal consistency (Types 3-4 based on Bristol Stool Scale) per week
time frame: 12 weeks
measure: Average weekly change of PEG or lactulose frequency and dosage as compared to baseline during the 12-week treatment phase
time frame: 12 weeks
measure: Improvement of constipation symptoms and higher satisfaction as measured by subject's global assessments and PAC-SYM scores. Improvement is defined as that the mean score reduction from baseline is ≥0.2
time frame: Baseline, 12 weeks
measure: Improvement in physical, psychological, and emotional stress as measured by PAC QOL scores. Improvement is defined as that the mean score reduction from baseline is ≥0.3
time frame: Baseline, 12 weeks
arm group label: Prucalopride plus Polyethylene glycol or lactulose
arm group type: Experimental
intervention type: Drug
intervention name: Prucalopride
description: During the 12-week treatment phase of the study, the daily dose of 1 tablet of 2-mg prucalopride will be administrated orally before breakfast.
arm group label: Prucalopride plus Polyethylene glycol or lactulose
intervention type: Drug
intervention name: Polyethylene glycol (PEG)
description: Optimized dose of PEG will be administrated for 13 weeks (1 week run-in+12 weeks intervention).
arm group label: Prucalopride plus Polyethylene glycol or lactulose
intervention type: Drug
intervention name: Lactulose
description: Optimized dose of Lactulose will be administrated for 13 weeks (1 week run-in+12 weeks intervention).
arm group label: Prucalopride plus Polyethylene glycol or lactulose
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Xian-Janssen Pharmaceutical Ltd., China Clinical Trial
role: Study Director
affiliation: Xian-Janssen Pharmaceutical Ltd.
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: China
url: http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_7051&studyid=5049&filename=CR102381_CSR.pdf
description: A Multicenter, Single-Arm, Interventional, Phase 4 Study to Evaluate the Efficacy and Safety of Prucalopride in Combination With PEG or Lactulose in Women With Chronic Constipation (CC)
responsible party type: Sponsor
mesh term: Constipation
mesh term: Lactulose
mesh term: Prucalopride