<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/NCT02260154</url>
  </required_header>
  <id_info>
    <org_study_id>MEBE5002</org_study_id>
    <nct_id>NCT02260154</nct_id>
  </id_info>
  <brief_title>Effectiveness of Duspatalin® in Patients With Post-cholecystectomy Gastrointestinal Spasm</brief_title>
  <acronym>ODYSSEY</acronym>
  <official_title>Effectiveness of Duspatalin® (Mebeverine Hydrochloride) 200 mg b.i.d. in Patients With Post-cholecystectomy Gastrointestinal Spasm: a Post Marketing Observational Program in the Russian Federation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abbott</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abbott</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective, multicenter, non-comparative, observational program designed to assess the&#xD;
      effectiveness of a 2-6 weeks treatment with Duspatalin® 200mg bis in die = twice a day (BID)&#xD;
      and changes in quality of life in patients with post-cholecystectomy gastro-intestinal spasms&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2015</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">October 2016</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>Percentage of &quot;Responders&quot; to Duspatalin® Therapy</measure>
    <time_frame>2 weeks</time_frame>
    <description>Patients indicating being 'symptom-free' or 'markedly improved'on Global Patient Assessment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of &quot;Responders&quot; to Duspatalin® Therapy</measure>
    <time_frame>Up to 6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Abdominal Pain</measure>
    <time_frame>Baseline, 2 weeks and up to 6 weeks</time_frame>
    <description>Measured by 11-items Numerous Rating Scale where 0 represents no pain and 10 represents the worst pain. Negative change corresponds to better result. Changes are calculated as Week 2 value minus Baseline value and Week 6 value minus Baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Dyspepsia Symptoms</measure>
    <time_frame>Baseline, 2 weeks and up to 6 weeks</time_frame>
    <description>Measured by 11-items Numerous Rating Scale where 0 represents no symptoms and 10 represents the worst symptoms. Negative change corresponds to better result. Changes are calculated as Week 2 value minus Baseline value and Week 6 value minus Baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Stool Habits and Percentage of Patients Reporting Abnormal Stool Form</measure>
    <time_frame>Baseline to Week 2</time_frame>
    <description>Changes in Stool Habits: The change is presented as the proportion of patients whose Changes in Stool Habits from 'Abnormal' to 'Normal' and vice versa were registered. &quot;Positive&quot; is defined as Change from 'Abnormal stool form at BL' to 'Normal stool form at Week 2'. &quot;Negative&quot; is defined as Change from 'Normal stool form at BL' to 'Abnormal stool form at Week 2'.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Quality of Life</measure>
    <time_frame>Baseline, 2 weeks and up to 6 weeks</time_frame>
    <description>Gastrointestinal Quality of Life Index contains 36 questions with 4 possible answers per each (most desirable option returns 4 points, and least desirable option returns 0 points). Total score of the GIQLI is calculated as sum of all items. The source scores are transformed and scaled from 0 to 100. The high score corresponds to better result. Changes are calculated as Week 2 value minus Baseline value and Week 6 value minus Baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Economic Data</measure>
    <time_frame>Baseline, up to 6 weeks</time_frame>
    <description>Relevant concomitant medication</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reasons for Continuing Treatment Beyond 2 Weeks</measure>
    <time_frame>2 weeks</time_frame>
    <description>List and rate of reasons</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Healths Economic Data 2</measure>
    <time_frame>from baseline at Week 6</time_frame>
    <description>Number of visits to clinic for currently employed subjects. Change is calculated as Week 6 value minus Baseline value. Negative change means less number of visits to clinic.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Economics Data 3</measure>
    <time_frame>change from baseline at Week 6</time_frame>
    <description>Number of days missed from work for currently employed subjects. Change is calculated as Week 6 value minus Baseline value. Negative change means less number of days missed from work.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Stool Habits and Percentage of Patients Reporting Abnormal Stool Form 2</measure>
    <time_frame>Baseline to Week 6</time_frame>
    <description>Changes in Stool Habits: The change is presented as the proportion of patients whose Changes in Stool Habits from 'Abnormal' to 'Normal' and vice versa were registered. &quot;Positive&quot; is defined as Change from 'Abnormal stool form at BL' to 'Normal stool form at Week 6'. &quot;Negative&quot; is defined as Change from 'Normal stool form at BL' to 'Abnormal stool form at Week 6'.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">220</enrollment>
  <condition>Post-cholecystectomy Gastrointestinal Spasms</condition>
  <arm_group>
    <arm_group_label>Post-cholecystectomy gastrointestinal spasms</arm_group_label>
    <description>Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mebeverine</intervention_name>
    <description>Subjects treated by Duspatalin (mebeverine) 200 mg BID (bis in die = twice a day) upto 6 weeks in accordance with routine practice will be observed</description>
    <arm_group_label>Post-cholecystectomy gastrointestinal spasms</arm_group_label>
    <other_name>Duspatalin</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Primary care clinic&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female ≥ 18 years to 65 years;&#xD;
&#xD;
          -  Patients suffering from post-cholecystectomy GI-spasms in the last 3 months with&#xD;
             symptom onset at least 6 months prior to inclusion and not requiring surgical&#xD;
             treatment;&#xD;
&#xD;
          -  Laparoscopic cholecystectomy between 6 months to 5 years before enrollment;&#xD;
&#xD;
          -  Patients having been prescribed Duspatalin® (mebeverine) 200 mg BID (bis in die =&#xD;
             twice a day) in accordance with approved local label;&#xD;
&#xD;
          -  Patient's written authorization to provide data for the program&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  General and specific contraindications to Duspatalin® treatment according to the local&#xD;
             label;&#xD;
&#xD;
          -  Planned Endoscopic Retrograde Cholangiopancreatography (ERCP) and/or surgical&#xD;
             treatment;&#xD;
&#xD;
          -  Being currently treated or having been treated with Duspatalin® within the 6 weeks&#xD;
             prior to entering the program;&#xD;
&#xD;
          -  Pregnancy or lactation;&#xD;
&#xD;
          -  Other conditions that make patient participation impossible (by investigator&#xD;
             judgment);&#xD;
&#xD;
          -  Previous enrollment in the present program;&#xD;
&#xD;
          -  Treatment with other antispasmodics, pain-medication (Nonsteroidal anti-inflammatory&#xD;
             drugs (NSAIDs), tramadol, etc.) within 2 weeks prior to inclusion into the&#xD;
             observational study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tatiana Vladimirova, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Abbott</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Facility ID ORG-001035</name>
      <address>
        <city>Chita</city>
        <zip>672090</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Budget Institution &quot; Irkutsk State Medical Academy of postgraduate education&quot;</name>
      <address>
        <city>Irkutsk</city>
        <zip>664049</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Facility ID ORG-001038</name>
      <address>
        <city>Izhevsk</city>
        <zip>426034</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Facility ID ORG-001033</name>
      <address>
        <city>Kazan</city>
        <zip>420029</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Non-governmental Healthcare Institution &quot;Road Clinical Hospital on the station Khabarovsk-1 OSS &quot;Russian Railways&quot;</name>
      <address>
        <city>Khabarovsk</city>
        <zip>680022</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Facility ID ORG-001034</name>
      <address>
        <city>Krasnoyarsk</city>
        <zip>660020</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research facility ID ORG-001039</name>
      <address>
        <city>Moscow</city>
        <zip>111123</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Federal State Budget Institution &quot;Outpatient hospital №1&quot; Administration of the President of the Russian Federation</name>
      <address>
        <city>Moscow</city>
        <zip>119002</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Budget Institution &quot;Pirogov Russian National Research Medical University&quot;, on the base of State Budget Institution of Health Care of Moscow &quot;City Clinical Hospital №31&quot;</name>
      <address>
        <city>Moscow</city>
        <zip>119415</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Budget Institution &quot;Russian Medical Academy of Postgraduate Studies</name>
      <address>
        <city>Moscow</city>
        <zip>123836</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Budget Institution of Health Care of Moscow region &quot; MF Vladimirsky Moscow Region Scientific Research Clinical University&quot;</name>
      <address>
        <city>Moscow</city>
        <zip>129110</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Facility ID ORG-001024</name>
      <address>
        <city>Moscow</city>
        <zip>129128</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Budget Institution &quot;Nizhny Novgorod Regional Clinical Hospital n.a. Semashko&quot;</name>
      <address>
        <city>Nizhny Novgorod</city>
        <zip>603126</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Budget Institution &quot;Novosibirsk State Medical University&quot;</name>
      <address>
        <city>Novosibirsk</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Facility ID ORG-000903</name>
      <address>
        <city>Omsk</city>
        <zip>644043</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Federal State Budget Institution Hospital of the Pushchino Scientific Center of the Russian Academy of Sciences</name>
      <address>
        <city>Pushino</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Facility ID ORG-001036</name>
      <address>
        <city>Rostov-on-Don</city>
        <zip>344022</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Federal State Budget Institution All-Russian Center of Emergency and Radiation Medicine of EMERCOM of Russia</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>194044</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Budget Institution &quot;North-Western State Medical University named after I.I. Mechnikov&quot;, on the base of State Budget Institution &quot;Sity Clinical Hospital #26&quot;</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>196247</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Facility ID ORG-001037</name>
      <address>
        <city>Saransk</city>
        <zip>430005</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City Clinical Hospital #40</name>
      <address>
        <city>Yekaterinburg</city>
        <zip>, 620102</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>September 29, 2014</study_first_submitted>
  <study_first_submitted_qc>October 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 9, 2014</study_first_posted>
  <results_first_submitted>December 5, 2017</results_first_submitted>
  <results_first_submitted_qc>March 1, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">June 6, 2019</results_first_posted>
  <last_update_submitted>March 1, 2019</last_update_submitted>
  <last_update_submitted_qc>March 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Duspatalin</keyword>
  <keyword>mebeverine</keyword>
  <keyword>cholecystectomy</keyword>
  <keyword>gastrointestinal spasm</keyword>
  <keyword>abdominal pain</keyword>
  <keyword>dyspepsia</keyword>
  <keyword>antispasmodics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscle Cramp</mesh_term>
    <mesh_term>Postcholecystectomy Syndrome</mesh_term>
    <mesh_term>Spasm</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mebeverine</mesh_term>
    <mesh_term>Alverine</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Post-cholecystectomy Gastrointestinal Spasms</title>
          <description>Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day&#xD;
Mebeverine: Subjects treated by Duspatalin (mebeverine) 200 mg bis in die = twice a day (BID) upto 6 weeks in accordance with routine practice will be observed</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="220"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="218"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Screening failure</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day</population>
      <group_list>
        <group group_id="B1">
          <title>Post-cholecystectomy Gastrointestinal Spasms</title>
          <description>Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day&#xD;
Mebeverine: Subjects treated by Duspatalin (mebeverine) 200 mg BID (bis in die = twice a day) upto 6 weeks in accordance with routine practice will be observed</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="218"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="218"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51.4" spread="10.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="180"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="216"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Russia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="218"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Working status</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>employed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="137"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>unemployed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of &quot;Responders&quot; to Duspatalin® Therapy</title>
        <description>Patients indicating being 'symptom-free' or 'markedly improved'on Global Patient Assessment</description>
        <time_frame>2 weeks</time_frame>
        <population>Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day</population>
        <group_list>
          <group group_id="O1">
            <title>Post-cholecystectomy Gastrointestinal Spasms</title>
            <description>Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day&#xD;
Mebeverine: Subjects treated by Duspatalin (mebeverine) 200 mg BID (bis in die = twice a day) upto 6 weeks in accordance with routine practice will be observed</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of &quot;Responders&quot; to Duspatalin® Therapy</title>
          <description>Patients indicating being 'symptom-free' or 'markedly improved'on Global Patient Assessment</description>
          <population>Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="218"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Symptom-free or markedly improved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.6" lower_limit="56.8" upper_limit="70.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other values (slightly improved, unchanged, worse)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.4" lower_limit="30.0" upper_limit="43.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of &quot;Responders&quot; to Duspatalin® Therapy</title>
        <time_frame>Up to 6 weeks</time_frame>
        <population>Extended set includes those patients who completed at least 6 weeks treatment of Duspatalin</population>
        <group_list>
          <group group_id="O1">
            <title>Post-cholecystectomy Gastrointestinal Spasms</title>
            <description>Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day&#xD;
Mebeverine: Subjects treated by Duspatalin (mebeverine) 200 mg BID (bis in die = twice a day) upto 6 weeks in accordance with routine practice will be observed</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of &quot;Responders&quot; to Duspatalin® Therapy</title>
          <population>Extended set includes those patients who completed at least 6 weeks treatment of Duspatalin</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="101"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.0" lower_limit="69.7" upper_limit="86.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Abdominal Pain</title>
        <description>Measured by 11-items Numerous Rating Scale where 0 represents no pain and 10 represents the worst pain. Negative change corresponds to better result. Changes are calculated as Week 2 value minus Baseline value and Week 6 value minus Baseline value.</description>
        <time_frame>Baseline, 2 weeks and up to 6 weeks</time_frame>
        <population>Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day</population>
        <group_list>
          <group group_id="O1">
            <title>Post-cholecystectomy Gastrointestinal Spasms</title>
            <description>Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day&#xD;
Mebeverine: Subjects treated by Duspatalin (mebeverine) 200 mg BID (bis in die = twice a day) upto 6 weeks in accordance with routine practice will be observed</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Abdominal Pain</title>
          <description>Measured by 11-items Numerous Rating Scale where 0 represents no pain and 10 represents the worst pain. Negative change corresponds to better result. Changes are calculated as Week 2 value minus Baseline value and Week 6 value minus Baseline value.</description>
          <population>Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>change from baseline at Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.7" spread="2.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>change from baseline at Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.4" spread="2.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Dyspepsia Symptoms</title>
        <description>Measured by 11-items Numerous Rating Scale where 0 represents no symptoms and 10 represents the worst symptoms. Negative change corresponds to better result. Changes are calculated as Week 2 value minus Baseline value and Week 6 value minus Baseline value.</description>
        <time_frame>Baseline, 2 weeks and up to 6 weeks</time_frame>
        <population>Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day</population>
        <group_list>
          <group group_id="O1">
            <title>Post-cholecystectomy Gastrointestinal Spasms</title>
            <description>Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day&#xD;
Mebeverine: Subjects treated by Duspatalin (mebeverine) 200 mg BID (bis in die = twice a day) upto 6 weeks in accordance with routine practice will be observed</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Dyspepsia Symptoms</title>
          <description>Measured by 11-items Numerous Rating Scale where 0 represents no symptoms and 10 represents the worst symptoms. Negative change corresponds to better result. Changes are calculated as Week 2 value minus Baseline value and Week 6 value minus Baseline value.</description>
          <population>Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>change from baseline at Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.0" spread="2.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>change from baseline at Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.3" spread="2.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Stool Habits and Percentage of Patients Reporting Abnormal Stool Form</title>
        <description>Changes in Stool Habits: The change is presented as the proportion of patients whose Changes in Stool Habits from 'Abnormal' to 'Normal' and vice versa were registered. &quot;Positive&quot; is defined as Change from 'Abnormal stool form at BL' to 'Normal stool form at Week 2'. &quot;Negative&quot; is defined as Change from 'Normal stool form at BL' to 'Abnormal stool form at Week 2'.</description>
        <time_frame>Baseline to Week 2</time_frame>
        <population>Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day</population>
        <group_list>
          <group group_id="O1">
            <title>Post-cholecystectomy Gastrointestinal Spasms</title>
            <description>Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day&#xD;
Mebeverine: Subjects treated by Duspatalin (mebeverine) 200 mg BID (bis in die = twice a day) upto 6 weeks in accordance with routine practice will be observed</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Stool Habits and Percentage of Patients Reporting Abnormal Stool Form</title>
          <description>Changes in Stool Habits: The change is presented as the proportion of patients whose Changes in Stool Habits from 'Abnormal' to 'Normal' and vice versa were registered. &quot;Positive&quot; is defined as Change from 'Abnormal stool form at BL' to 'Normal stool form at Week 2'. &quot;Negative&quot; is defined as Change from 'Normal stool form at BL' to 'Abnormal stool form at Week 2'.</description>
          <population>Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Positive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Negative</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Quality of Life</title>
        <description>Gastrointestinal Quality of Life Index contains 36 questions with 4 possible answers per each (most desirable option returns 4 points, and least desirable option returns 0 points). Total score of the GIQLI is calculated as sum of all items. The source scores are transformed and scaled from 0 to 100. The high score corresponds to better result. Changes are calculated as Week 2 value minus Baseline value and Week 6 value minus Baseline value.</description>
        <time_frame>Baseline, 2 weeks and up to 6 weeks</time_frame>
        <population>Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day</population>
        <group_list>
          <group group_id="O1">
            <title>Post-cholecystectomy Gastrointestinal Spasms</title>
            <description>Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day&#xD;
Mebeverine: Subjects treated by Duspatalin (mebeverine) 200 mg BID (bis in die = twice a day) upto 6 weeks in accordance with routine practice will be observed</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Quality of Life</title>
          <description>Gastrointestinal Quality of Life Index contains 36 questions with 4 possible answers per each (most desirable option returns 4 points, and least desirable option returns 0 points). Total score of the GIQLI is calculated as sum of all items. The source scores are transformed and scaled from 0 to 100. The high score corresponds to better result. Changes are calculated as Week 2 value minus Baseline value and Week 6 value minus Baseline value.</description>
          <population>Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>change from baseline at Week 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.802" spread="11.8489"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>change from baseline at Week 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.737" spread="13.4339"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Health Economic Data</title>
        <description>Relevant concomitant medication</description>
        <time_frame>Baseline, up to 6 weeks</time_frame>
        <population>Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day</population>
        <group_list>
          <group group_id="O1">
            <title>Post-cholecystectomy Gastrointestinal Spasms</title>
            <description>Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day&#xD;
Mebeverine: Subjects treated by Duspatalin (mebeverine) 200 mg BID (bis in die = twice a day) upto 6 weeks in accordance with routine practice will be observed</description>
          </group>
        </group_list>
        <measure>
          <title>Health Economic Data</title>
          <description>Relevant concomitant medication</description>
          <population>Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="218"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ACE inhibitors</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alpha adrenoreceptor antagonist</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Aluminium compounds</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Angiotensine II antagonist</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anti arrhythmics</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anti diarrheal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anti inflammatory</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Barbiturates</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Beta blocking against agents, selective</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Biguaniges</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bile acid preparations</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bioflavonoids</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Blood transfusion, auxilary products</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Beta blocking agents, and other antihypertensives</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Beta blocking agents, thiazides</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Reasons for Continuing Treatment Beyond 2 Weeks</title>
        <description>List and rate of reasons</description>
        <time_frame>2 weeks</time_frame>
        <population>Extended Set includes those patients who completed at least 6 weeks treatment of Duspatalin</population>
        <group_list>
          <group group_id="O1">
            <title>Post-cholecystectomy Gastrointestinal Spasms</title>
            <description>Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day&#xD;
Mebeverine: Subjects treated by Duspatalin (mebeverine) 200 mg BID (bis in die = twice a day) upto 6 weeks in accordance with routine practice will be observed</description>
          </group>
        </group_list>
        <measure>
          <title>Reasons for Continuing Treatment Beyond 2 Weeks</title>
          <description>List and rate of reasons</description>
          <population>Extended Set includes those patients who completed at least 6 weeks treatment of Duspatalin</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="101"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Expectation in higher effectiveness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tend to treat beyond 2 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maintenance of achieved effect</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Healths Economic Data 2</title>
        <description>Number of visits to clinic for currently employed subjects. Change is calculated as Week 6 value minus Baseline value. Negative change means less number of visits to clinic.</description>
        <time_frame>from baseline at Week 6</time_frame>
        <population>Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day</population>
        <group_list>
          <group group_id="O1">
            <title>Post-cholecystectomy Gastrointestinal Spasms</title>
            <description>Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day&#xD;
Mebeverine: Subjects treated by Duspatalin (mebeverine) 200 mg bis in die = twice a day (BID) upto 6 weeks in accordance with routine practice will be observed</description>
          </group>
        </group_list>
        <measure>
          <title>Healths Economic Data 2</title>
          <description>Number of visits to clinic for currently employed subjects. Change is calculated as Week 6 value minus Baseline value. Negative change means less number of visits to clinic.</description>
          <population>Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day</population>
          <units>number of visits</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="101"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.9" spread="1.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Health Economics Data 3</title>
        <description>Number of days missed from work for currently employed subjects. Change is calculated as Week 6 value minus Baseline value. Negative change means less number of days missed from work.</description>
        <time_frame>change from baseline at Week 6</time_frame>
        <population>Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200mg twice a day</population>
        <group_list>
          <group group_id="O1">
            <title>Post-cholecystectomy Gastrointestinal Spasms</title>
            <description>Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day&#xD;
Mebeverine: Subjects treated by Duspatalin (mebeverine) 200 mg bis in die = twice a day (BID) upto 6 weeks in accordance with routine practice will be observed</description>
          </group>
        </group_list>
        <measure>
          <title>Health Economics Data 3</title>
          <description>Number of days missed from work for currently employed subjects. Change is calculated as Week 6 value minus Baseline value. Negative change means less number of days missed from work.</description>
          <population>Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200mg twice a day</population>
          <units>Number of days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="57"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.1" spread="3.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Stool Habits and Percentage of Patients Reporting Abnormal Stool Form 2</title>
        <description>Changes in Stool Habits: The change is presented as the proportion of patients whose Changes in Stool Habits from 'Abnormal' to 'Normal' and vice versa were registered. &quot;Positive&quot; is defined as Change from 'Abnormal stool form at BL' to 'Normal stool form at Week 6'. &quot;Negative&quot; is defined as Change from 'Normal stool form at BL' to 'Abnormal stool form at Week 6'.</description>
        <time_frame>Baseline to Week 6</time_frame>
        <population>Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day</population>
        <group_list>
          <group group_id="O1">
            <title>Post-cholecystectomy Gastrointestinal Spasms</title>
            <description>Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day&#xD;
Mebeverine: Subjects treated by Duspatalin (mebeverine) 200 mg bis in die = twice a day (BID) upto 6 weeks in accordance with routine practice will be observed</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Stool Habits and Percentage of Patients Reporting Abnormal Stool Form 2</title>
          <description>Changes in Stool Habits: The change is presented as the proportion of patients whose Changes in Stool Habits from 'Abnormal' to 'Normal' and vice versa were registered. &quot;Positive&quot; is defined as Change from 'Abnormal stool form at BL' to 'Normal stool form at Week 6'. &quot;Negative&quot; is defined as Change from 'Normal stool form at BL' to 'Abnormal stool form at Week 6'.</description>
          <population>Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Positive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Negative</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Post-cholecystectomy Gastrointestinal Spasms</title>
          <description>Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day&#xD;
Mebeverine: Subjects treated by Duspatalin (mebeverine) 200 mg BID (bis in die = twice a day) upto 6 weeks in accordance with routine practice will be observed</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="218"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis allergic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="218"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Tatiana V. Vladimirova MD, PhD</name_or_title>
      <organization>Abbott</organization>
      <phone>+7 495-258-4280</phone>
      <email>tatiana.vladimirova@abbott.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02260154
org study id: MEBE5002
nct id: NCT02260154
lead sponsor: 
has dmc: No
Prospective, multicenter, non-comparative, observational program designed to assess the
      effectiveness of a 2-6 weeks treatment with Duspatalin® 200mg bis in die = twice a day (BID)
      and changes in quality of life in patients with post-cholecystectomy gastro-intestinal spasms
observational model: Cohort
time perspective: Prospective
measure: Percentage of "Responders" to Duspatalin® Therapy
time frame: 2 weeks
description: Patients indicating being 'symptom-free' or 'markedly improved'on Global Patient Assessment
measure: Percentage of "Responders" to Duspatalin® Therapy
time frame: Up to 6 weeks
measure: Changes in Abdominal Pain
time frame: Baseline, 2 weeks and up to 6 weeks
description: Measured by 11-items Numerous Rating Scale where 0 represents no pain and 10 represents the worst pain. Negative change corresponds to better result. Changes are calculated as Week 2 value minus Baseline value and Week 6 value minus Baseline value.
measure: Changes in Dyspepsia Symptoms
time frame: Baseline, 2 weeks and up to 6 weeks
description: Measured by 11-items Numerous Rating Scale where 0 represents no symptoms and 10 represents the worst symptoms. Negative change corresponds to better result. Changes are calculated as Week 2 value minus Baseline value and Week 6 value minus Baseline value.
measure: Changes in Stool Habits and Percentage of Patients Reporting Abnormal Stool Form
time frame: Baseline to Week 2
description: Changes in Stool Habits: The change is presented as the proportion of patients whose Changes in Stool Habits from 'Abnormal' to 'Normal' and vice versa were registered. "Positive" is defined as Change from 'Abnormal stool form at BL' to 'Normal stool form at Week 2'. "Negative" is defined as Change from 'Normal stool form at BL' to 'Abnormal stool form at Week 2'.
measure: Changes in Quality of Life
time frame: Baseline, 2 weeks and up to 6 weeks
description: Gastrointestinal Quality of Life Index contains 36 questions with 4 possible answers per each (most desirable option returns 4 points, and least desirable option returns 0 points). Total score of the GIQLI is calculated as sum of all items. The source scores are transformed and scaled from 0 to 100. The high score corresponds to better result. Changes are calculated as Week 2 value minus Baseline value and Week 6 value minus Baseline value.
measure: Health Economic Data
time frame: Baseline, up to 6 weeks
description: Relevant concomitant medication
measure: Reasons for Continuing Treatment Beyond 2 Weeks
time frame: 2 weeks
description: List and rate of reasons
measure: Healths Economic Data 2
time frame: from baseline at Week 6
description: Number of visits to clinic for currently employed subjects. Change is calculated as Week 6 value minus Baseline value. Negative change means less number of visits to clinic.
measure: Health Economics Data 3
time frame: change from baseline at Week 6
description: Number of days missed from work for currently employed subjects. Change is calculated as Week 6 value minus Baseline value. Negative change means less number of days missed from work.
measure: Changes in Stool Habits and Percentage of Patients Reporting Abnormal Stool Form 2
time frame: Baseline to Week 6
description: Changes in Stool Habits: The change is presented as the proportion of patients whose Changes in Stool Habits from 'Abnormal' to 'Normal' and vice versa were registered. "Positive" is defined as Change from 'Abnormal stool form at BL' to 'Normal stool form at Week 6'. "Negative" is defined as Change from 'Normal stool form at BL' to 'Abnormal stool form at Week 6'.
arm group label: Post-cholecystectomy gastrointestinal spasms
description: Adult subjects suffering from post-cholecystectomy gastrointestinal spasms not requiring surgical treatment prescribed Duspatalin® 200 mg twice a day
intervention type: Drug
intervention name: Mebeverine
description: Subjects treated by Duspatalin (mebeverine) 200 mg BID (bis in die = twice a day) upto 6 weeks in accordance with routine practice will be observed
arm group label: Post-cholecystectomy gastrointestinal spasms
other name: Duspatalin
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Tatiana Vladimirova, MD, PhD
role: Study Director
affiliation: Abbott
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country: Russian Federation
responsible party type: Sponsor
mesh term: Muscle Cramp
mesh term: Postcholecystectomy Syndrome
mesh term: Spasm
mesh term: Mebeverine
mesh term: Alverine
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 