<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/NCT01678781</url>
  </required_header>
  <id_info>
    <org_study_id>P13-678</org_study_id>
    <nct_id>NCT01678781</nct_id>
  </id_info>
  <brief_title>Open International Study on Quality of Life in Irritable Bowel Syndrome (IBS) Patients Before and After 8 Weeks Treatment With Mebeverine/Pinaverium Bromide</brief_title>
  <official_title>Open International Study on Quality of Life in IBS Patients Before and After 8 Weeks Treatment With Mebeverine/Pinaverium Bromide</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abbott</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>CHILTERN International GmbH</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Abbott</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A study to evaluate, by country and overall, the changes from baseline of the irritable bowel&#xD;
      syndrome quality of life (IBS QoL) total score after 4 and 8 weeks of treatment with&#xD;
      Duspatalin® or Dicetel® in IBS patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">August 2013</completion_date>
  <primary_completion_date type="Actual">August 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Irritable Bowel syndrome (IBS) quality of life (QoL) measure (IBS-QoL) to assess the impairment of QoL in IBS patients</measure>
    <time_frame>From baseline up to the week 8 visit</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in abdominal pain</measure>
    <time_frame>From baseline up to the week 8 visit</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in bloating</measure>
    <time_frame>From baseline up to the week 8 visit</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in feeling of abdominal distension</measure>
    <time_frame>From baseline up to the week 8 visit</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in stool frequency</measure>
    <time_frame>From baseline up to the week 8 visit</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in stool form</measure>
    <time_frame>From baseline up to the week 8 visit</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in straining of evacuation</measure>
    <time_frame>From baseline up to the week 8 visit</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in urgency of evacuation</measure>
    <time_frame>From baseline up to the week 8 visit</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in feeling of incomplete evacuation</measure>
    <time_frame>From baseline up to the week 8 visit</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">607</enrollment>
  <condition>Irritable Bowel Syndrome</condition>
  <arm_group>
    <arm_group_label>One patient group</arm_group_label>
    <description>Patients suffering from irritable bowel syndrome</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Primary care clinic, community sample&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Irritable bowel syndrome patients diagnosed by Rome III criteria (18 years or older)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy and lactation&#xD;
&#xD;
          -  Specific contraindications to mebeverine hydrochloride or pinaverium bromide&#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>Guenter Krause</last_name>
    <role>Study Director</role>
    <affiliation>Abbott</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Site reference ID/Investigator# 94519</name>
      <address>
        <city>Beijing</city>
        <zip>100034</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigator# 95475</name>
      <address>
        <city>Guangzhou City</city>
        <zip>510515</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigator# 94521</name>
      <address>
        <city>Guangzhou</city>
        <zip>510080</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigator # 94518</name>
      <address>
        <city>Shanghai</city>
        <zip>200127</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigator # 94517</name>
      <address>
        <city>Shanghai</city>
        <zip>200433</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigator # 94516</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigator # 94515</name>
      <address>
        <city>Wuhan</city>
        <zip>430022</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 95908</name>
      <address>
        <city>Alexandria</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigator# 95900</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigator# 95901</name>
      <address>
        <city>El Sharkya</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigator# 95902</name>
      <address>
        <city>Giza</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigator# 95903</name>
      <address>
        <city>Giza</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 95906</name>
      <address>
        <city>Port Said</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigaot# 94525</name>
      <address>
        <city>Guadalajara</city>
        <zip>49000</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site refernce ID/Investigator# 94527</name>
      <address>
        <city>Mexico City</city>
        <zip>54055</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigator# 94523</name>
      <address>
        <city>Tampico</city>
        <zip>89190</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigator# 85314</name>
      <address>
        <city>Bialystok</city>
        <zip>15-270</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 85297</name>
      <address>
        <city>Bialystok</city>
        <zip>15-351</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 85298</name>
      <address>
        <city>Bydgoszcz</city>
        <zip>85-079</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 85293</name>
      <address>
        <city>Katowice</city>
        <zip>40-031</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 85296</name>
      <address>
        <city>Lodz</city>
        <zip>91-473</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site reference ID/Investigator# 85313</name>
      <address>
        <city>Olsztyn</city>
        <zip>10-501</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 85295</name>
      <address>
        <city>Poznan</city>
        <zip>60-193</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site Reference ID/Investigator# 85294</name>
      <address>
        <city>Poznan</city>
        <zip>60-539</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
    <country>Egypt</country>
    <country>Mexico</country>
    <country>Poland</country>
  </location_countries>
  <verification_date>September 2013</verification_date>
  <study_first_submitted>July 13, 2012</study_first_submitted>
  <study_first_submitted_qc>September 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2012</study_first_posted>
  <last_update_submitted>September 6, 2013</last_update_submitted>
  <last_update_submitted_qc>September 6, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 9, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Abdominal pain</keyword>
  <keyword>Diarrhea</keyword>
  <keyword>Mebeverine hydrochloride</keyword>
  <keyword>Constipation</keyword>
  <keyword>Pinaverium bromide</keyword>
  <keyword>Irritable bowel syndrome</keyword>
  <keyword>Bloating</keyword>
  <keyword>Quality of life</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>
  </condition_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/NCT01678781
org study id: P13-678
nct id: NCT01678781
lead sponsor: 
collaborator: 
has dmc: No
A study to evaluate, by country and overall, the changes from baseline of the irritable bowel
      syndrome quality of life (IBS QoL) total score after 4 and 8 weeks of treatment with
      Duspatalin® or Dicetel® in IBS patients.
observational model: Case-Control
time perspective: Prospective
measure: Change in Irritable Bowel syndrome (IBS) quality of life (QoL) measure (IBS-QoL) to assess the impairment of QoL in IBS patients
time frame: From baseline up to the week 8 visit
measure: Change in abdominal pain
time frame: From baseline up to the week 8 visit
measure: Change in bloating
time frame: From baseline up to the week 8 visit
measure: Change in feeling of abdominal distension
time frame: From baseline up to the week 8 visit
measure: Change in stool frequency
time frame: From baseline up to the week 8 visit
measure: Change in stool form
time frame: From baseline up to the week 8 visit
measure: Change in straining of evacuation
time frame: From baseline up to the week 8 visit
measure: Change in urgency of evacuation
time frame: From baseline up to the week 8 visit
measure: Change in feeling of incomplete evacuation
time frame: From baseline up to the week 8 visit
arm group label: One patient group
description: Patients suffering from irritable bowel syndrome
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Guenter Krause
role: Study Director
affiliation: Abbott
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country: China
country: Egypt
country: Mexico
country: Poland
responsible party type: Sponsor
mesh term: Irritable Bowel Syndrome
mesh term: Syndrome