<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/NCT02211976</url>
  </required_header>
  <id_info>
    <org_study_id>122.52</org_study_id>
    <nct_id>NCT02211976</nct_id>
  </id_info>
  <brief_title>Efficacy and Tolerability of Bisacodyl Sugar Coated Tablets, Simeticone Chewing Tablets and Their Combination in Constipation and Bloatedness</brief_title>
  <official_title>Comparative Efficacy and Tolerability of Bisacodyl Sugar Coated Tablets, Simeticone Chewing Tablets and the Combination of Both in the Treatment of Constipation and Bloatedness: an Open, Randomised, Parallel Group Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      Pilot study to evaluate the efficacy and tolerability of the combined treatment of bisacodyl&#xD;
      and simeticone compared with the efficacy and tolerability of the single products in patients&#xD;
      suffering from constipation and bloatedness&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2003</start_date>
  <primary_completion_date type="Actual">November 2003</primary_completion_date>
  <phase>Phase 3</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in bloatedness score on a 4-point-scale</measure>
    <time_frame>baseline, 1 hour after drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in bloatedness score on a 4-point-scale</measure>
    <time_frame>baseline, 2 hours, 3 hours, at time of defecation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to defecation</measure>
    <time_frame>up to 7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of withdrawals due to inadequate efficiency</measure>
    <time_frame>up to 7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's global assessment of efficacy on a 4-point-scale</measure>
    <time_frame>up to 7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to 7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with abnormal laboratory findings</measure>
    <time_frame>up to 7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of withdrawals due to safety reasons</measure>
    <time_frame>up to 7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's assessment of overall tolerability on a 4-point-scale</measure>
    <time_frame>up to 7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Investigator's assessment of overall tolerability on a 4-point-scale</measure>
    <time_frame>up to 7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinically significant changes in vital signs</measure>
    <time_frame>up to 7 days</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Constipation</condition>
  <arm_group>
    <arm_group_label>Bisacodyl</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Simeticone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Bisacodyl and simeticone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bisacodyl</intervention_name>
    <arm_group_label>Bisacodyl</arm_group_label>
    <arm_group_label>Bisacodyl and simeticone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Simeticone</intervention_name>
    <arm_group_label>Bisacodyl and simeticone</arm_group_label>
    <arm_group_label>Simeticone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of constipation, defined as acute and habitual constipation; concomitantly&#xD;
             patient must have complaint of bloated feeling&#xD;
&#xD;
          -  Patient was to be 18 years of age or older&#xD;
&#xD;
          -  Females who were of child bearing potential must have a negative pre-study urine&#xD;
             pregnancy test and must be using oral or barrier contraceptive methods throughout the&#xD;
             study. If oral contraceptives were used, the patient must be using them for at least 3&#xD;
             months prior to enrolment into the study&#xD;
&#xD;
          -  Patient must be willing to maintain a diary throughout the study&#xD;
&#xD;
          -  Patient must be otherwise in good health&#xD;
&#xD;
          -  Patient must sign an informed consent form which has been prepared in accordance with&#xD;
             the Declaration of Helsinki&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient had drug-induced constipation resulting from drugs such as opioids,&#xD;
             dopaminergics, antacids, anticholinergics or diuretics&#xD;
&#xD;
          -  Patient had a history of organic diseases of the colon such as tumors, stricture, and&#xD;
             acute or chronic inflammatory diseases, ileus, acute surgical abdominal conditions&#xD;
             such as acute appendicitis, or organic diseases of the rectum and anus such as&#xD;
             fissures, fistulas, perianal abscesses, and eczema of the perianal skin&#xD;
&#xD;
          -  Patient exhibited evidence of active gastrointestinal disease&#xD;
&#xD;
          -  Patient was diagnosed as having intestinal obstruction, had any undiagnosed abdominal&#xD;
             symptoms, or was in severe dehydration&#xD;
&#xD;
          -  Patient had a history of major gastrointestinal surgery&#xD;
&#xD;
          -  Patient had a history of hypersensitivity to substances of the triarylmethane class&#xD;
&#xD;
          -  Patient had a history of hypersensitivity to substances of the class of&#xD;
             parahydroxybenzoic esters (para group allergy)&#xD;
&#xD;
          -  Patient had a history of drug or alcohol abuse&#xD;
&#xD;
          -  Patient had received bisacodyl for the treatment of another indication or in a&#xD;
             previous study within the last 7 days before enrolment.&#xD;
&#xD;
          -  Patient had ingested any drug in the past week before enrolment that in the opinion of&#xD;
             the investigator would have an effect on gastrointestinal motility (e.g.&#xD;
             anti-cholinergic medications, opioids, smooth muscle relaxants or antacids)&#xD;
&#xD;
          -  Patient required the use of a drug, other than study drug, or dietary supplement to&#xD;
             relieve the symptoms of constipation at any time during the baseline or treatment&#xD;
             phases of this study&#xD;
&#xD;
          -  Patient was currently taking any form of tetracycline antibiotics&#xD;
&#xD;
          -  Patient was a nursing mother&#xD;
&#xD;
          -  Patient had received any investigational drug within the previous 4 weeks prior to&#xD;
             enrolment&#xD;
&#xD;
          -  Patient had any condition that would interfere with the completion of this study, or&#xD;
             that would decrease the likelihood of obtaining valid results&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 7, 2014</study_first_submitted>
  <study_first_submitted_qc>August 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2014</study_first_posted>
  <last_update_submitted>August 7, 2014</last_update_submitted>
  <last_update_submitted_qc>August 7, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 8, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Constipation</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bisacodyl</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02211976
org study id: 122.52
nct id: NCT02211976
lead sponsor: 
Pilot study to evaluate the efficacy and tolerability of the combined treatment of bisacodyl
      and simeticone compared with the efficacy and tolerability of the single products in patients
      suffering from constipation and bloatedness
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in bloatedness score on a 4-point-scale
time frame: baseline, 1 hour after drug administration
measure: Change in bloatedness score on a 4-point-scale
time frame: baseline, 2 hours, 3 hours, at time of defecation
measure: Time to defecation
time frame: up to 7 days
measure: Number of withdrawals due to inadequate efficiency
time frame: up to 7 days
measure: Patient's global assessment of efficacy on a 4-point-scale
time frame: up to 7 days
measure: Number of patients with adverse events
time frame: up to 7 days
measure: Number of patients with abnormal laboratory findings
time frame: up to 7 days
measure: Number of withdrawals due to safety reasons
time frame: up to 7 days
measure: Patient's assessment of overall tolerability on a 4-point-scale
time frame: up to 7 days
measure: Investigator's assessment of overall tolerability on a 4-point-scale
time frame: up to 7 days
measure: Number of patients with clinically significant changes in vital signs
time frame: up to 7 days
arm group label: Bisacodyl
arm group type: Experimental
arm group label: Simeticone
arm group type: Experimental
arm group label: Bisacodyl and simeticone
arm group type: Experimental
intervention type: Drug
intervention name: Bisacodyl
arm group label: Bisacodyl
arm group label: Bisacodyl and simeticone
intervention type: Drug
intervention name: Simeticone
arm group label: Bisacodyl and simeticone
arm group label: Simeticone
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Constipation
mesh term: Bisacodyl