<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/NCT01714843</url>
  </required_header>
  <id_info>
    <org_study_id>0456-CL-0021</org_study_id>
    <nct_id>NCT01714843</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Effect of ASP0456 in Patients With Constipation Predominant Irritable Bowel Syndrome</brief_title>
  <official_title>Phase II Study of ASP0456 - A Double-blind, Placebo-controlled, Parallel-group, Comparative Study in Patients With Constipation-predominant Irritable Bowel Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Astellas Pharma Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Astellas Pharma Inc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is to investigate the efficacy, safety, and plasma concentration change of ASP0456&#xD;
      in patients with constipation-predominant irritable bowel syndrome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a multicenter, double-blind, placebo-controlled, parallel-group, comparative&#xD;
      study to investigate dose-responses of efficacy, safety, and pharmacokinetics of ASP0456 in&#xD;
      patients with constipation-predominant irritable bowel syndrome (IBS-C) according to the Rome&#xD;
      III Diagnostic Criteria (2006 revised edition, established by the Rome III Committee) after&#xD;
      oral administration of ASP0456.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 10, 2012</start_date>
  <completion_date type="Actual">December 7, 2013</completion_date>
  <primary_completion_date type="Actual">December 7, 2013</primary_completion_date>
  <phase>Phase 2</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Global assessment of relief of IBS symptoms Responder</measure>
    <time_frame>Weekly for 12 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>SBM (Spontaneous Bowel Movement) Responder</measure>
    <time_frame>Weekly for 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CSBM (Complete SBM) Responder</measure>
    <time_frame>Weekly for 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Abnormal bowel habits improvement Responder</measure>
    <time_frame>Weekly for 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Abdominal pain/discomfort relief Responder</measure>
    <time_frame>Weekly for 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in weekly average of SBM frequency</measure>
    <time_frame>Weekly for 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in weekly average of CSBM frequency</measure>
    <time_frame>Weekly for 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in weekly average of stool form scores</measure>
    <time_frame>Weekly for 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in weekly average of abdominal pain/discomfort severity</measure>
    <time_frame>Weekly for 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in weekly average of straining severity</measure>
    <time_frame>Weekly for 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in IBS-QOL-J scores (entire scores or scores on the sub-scales)</measure>
    <time_frame>Weekly for 12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety assessed by the incidence of adverse events, vital signs, clinical laboratory tests and 12-lead ECGs</measure>
    <time_frame>for 12 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">559</enrollment>
  <condition>Constipation-predominant Irritable Bowel Syndrome (IBS-C)</condition>
  <arm_group>
    <arm_group_label>ASP0456 lowest dose group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>oral</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ASP0456 low dose group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>oral</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ASP0456 middle dose group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>oral</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ASP0456 high dose group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>oral</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>oral</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>linaclotide</intervention_name>
    <description>oral</description>
    <arm_group_label>ASP0456 high dose group</arm_group_label>
    <arm_group_label>ASP0456 low dose group</arm_group_label>
    <arm_group_label>ASP0456 lowest dose group</arm_group_label>
    <arm_group_label>ASP0456 middle dose group</arm_group_label>
    <other_name>ASP0456</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>oral</description>
    <arm_group_label>placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who had abdominal pain or discomfort repeatedly for at least 3 days per month&#xD;
             during the 3 months before screening examination associated with at least 2 out of the&#xD;
             following 3 conditions: (1) Improvement with defecation; (2) Onset associated with a&#xD;
             change in frequency of stool; and (3) Onset associated with a change in form&#xD;
             (appearance) of stool, and had the above symptom (IBS symptom) 6 months or more before&#xD;
             the screening examination period.&#xD;
&#xD;
          -  Patients with ≥25% of stools hard or lumpy (with each bowel movement occurring without&#xD;
             antidiarrheal, laxative, suppository or enema) and &lt;25% of them loose (mushy) or&#xD;
             watery during the 3 months before the screening examination.&#xD;
&#xD;
          -  Patients who had pancolonoscopy or contrast enema (or sigmoidoscopy) after the onset&#xD;
             of IBS symptom and had no organic changes.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a history of surgical resection of the stomach, gallbladder, small&#xD;
             intestine or large intestine&#xD;
&#xD;
          -  Patients with other concurrent diseases that may affect the digestive tract passage or&#xD;
             large intestinal function&#xD;
&#xD;
          -  Patients with other concurrent diseases that may affect the assessment of abdominal&#xD;
             pain/discomfort&#xD;
&#xD;
          -  Patients with blood pressure, pulse rate, clinical laboratory test, or 12-lead ECG at&#xD;
             the time of screening examination that was rated as Grade 2 or greater on the&#xD;
             &quot;Severity Criteria for Drug Adverse Reaction&quot; and judged to be clinically significant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Astellas Pharma Inc</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Hokkaido</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kansai</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kantou</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kyusyu</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <link>
    <url>https://astellasclinicalstudyresults.com/study.aspx?ID=206</url>
    <description>Link to results on Astellas Clinical Study Results website</description>
  </link>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>October 22, 2012</study_first_submitted>
  <study_first_submitted_qc>October 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 26, 2012</study_first_posted>
  <last_update_submitted>January 9, 2020</last_update_submitted>
  <last_update_submitted_qc>January 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>irritable bowel syndrome (IBS)</keyword>
  <keyword>linaclotide</keyword>
  <keyword>constipation</keyword>
  <keyword>ASP0456</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Irritable Bowel Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Constipation</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Linaclotide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under &quot;Sponsor Specific Details for Astellas.&quot;</ipd_description>
  </patient_data>
  <!-- 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/NCT01714843
org study id: 0456-CL-0021
nct id: NCT01714843
lead sponsor: 
has dmc: No
This study is to investigate the efficacy, safety, and plasma concentration change of ASP0456
      in patients with constipation-predominant irritable bowel syndrome.
This study is a multicenter, double-blind, placebo-controlled, parallel-group, comparative
      study to investigate dose-responses of efficacy, safety, and pharmacokinetics of ASP0456 in
      patients with constipation-predominant irritable bowel syndrome (IBS-C) according to the Rome
      III Diagnostic Criteria (2006 revised edition, established by the Rome III Committee) after
      oral administration of ASP0456.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Global assessment of relief of IBS symptoms Responder
time frame: Weekly for 12 weeks
measure: SBM (Spontaneous Bowel Movement) Responder
time frame: Weekly for 12 weeks
measure: CSBM (Complete SBM) Responder
time frame: Weekly for 12 weeks
measure: Abnormal bowel habits improvement Responder
time frame: Weekly for 12 weeks
measure: Abdominal pain/discomfort relief Responder
time frame: Weekly for 12 weeks
measure: Changes in weekly average of SBM frequency
time frame: Weekly for 12 weeks
measure: Changes in weekly average of CSBM frequency
time frame: Weekly for 12 weeks
measure: Changes in weekly average of stool form scores
time frame: Weekly for 12 weeks
measure: Changes in weekly average of abdominal pain/discomfort severity
time frame: Weekly for 12 weeks
measure: Changes in weekly average of straining severity
time frame: Weekly for 12 weeks
measure: Changes in IBS-QOL-J scores (entire scores or scores on the sub-scales)
time frame: Weekly for 12 weeks
measure: Safety assessed by the incidence of adverse events, vital signs, clinical laboratory tests and 12-lead ECGs
time frame: for 12 weeks
arm group label: ASP0456 lowest dose group
arm group type: Experimental
description: oral
arm group label: ASP0456 low dose group
arm group type: Experimental
description: oral
arm group label: ASP0456 middle dose group
arm group type: Experimental
description: oral
arm group label: ASP0456 high dose group
arm group type: Experimental
description: oral
arm group label: placebo group
arm group type: Placebo Comparator
description: oral
intervention type: Drug
intervention name: linaclotide
description: oral
arm group label: ASP0456 high dose group
arm group label: ASP0456 low dose group
arm group label: ASP0456 lowest dose group
arm group label: ASP0456 middle dose group
other name: ASP0456
intervention type: Drug
intervention name: placebo
description: oral
arm group label: placebo group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 64 Years
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Astellas Pharma Inc
facility: 
facility: 
facility: 
facility: 
country: Japan
url: https://astellasclinicalstudyresults.com/study.aspx?ID=206
description: Link to results on Astellas Clinical Study Results website
responsible party type: Sponsor
mesh term: Irritable Bowel Syndrome
mesh term: Syndrome
mesh term: Constipation
mesh term: Linaclotide
sharing ipd: No
ipd description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."