<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/NCT02229786</url>
  </required_header>
  <id_info>
    <org_study_id>218.202</org_study_id>
    <nct_id>NCT02229786</nct_id>
  </id_info>
  <brief_title>Efficacy and Tolerability of Buscopan Plus in Painful Gastric or Intestinal Spasms</brief_title>
  <official_title>Buscopan® Plus, Buscopan®, Paracetamol and Placebo: Double-blind Randomized Group Comparison to Investigate the Efficacy and Tolerability of the Film-coated Tablets in Patients With Painful Gastric or Intestinal Spasms</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      Study to evaluate efficacy and tolerability of Buscopan® plus versus Buscopan®, paracetamol,&#xD;
      and placebo in patients with painful gastric or intestinal spasms.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 1998</start_date>
  <primary_completion_date type="Actual">October 1999</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean decrease in pain intensity on a VAS (visual analog scale)</measure>
    <time_frame>3 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Frequency of pain on a 4-stage verbal rating scale</measure>
    <time_frame>up to 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global assessment of efficacy by patient on a 5-point rating scale</measure>
    <time_frame>up to 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global assessment of efficacy by investigator on a 5-point rating scale</measure>
    <time_frame>up to 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to 4 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">1637</enrollment>
  <condition>Gastrointestinal Diseases</condition>
  <arm_group>
    <arm_group_label>Buscopan® plus</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Buscopan®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Paracetamol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Buscopan® plus</intervention_name>
    <arm_group_label>Buscopan® plus</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Buscopan®</intervention_name>
    <arm_group_label>Buscopan®</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paracetamol</intervention_name>
    <arm_group_label>Paracetamol</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female patients&#xD;
&#xD;
          -  Age: 18 - 70 years&#xD;
&#xD;
          -  Diagnosis: recurring painful gastric or intestinal spasms such as occur e.g. in&#xD;
             irritable bowel syndrome, which are not organic in origin, have been present for at&#xD;
             least 2 months, and are serious enough to interfere with everyday activities&#xD;
&#xD;
          -  Patient briefing as per §§ 40/41 of the Arzneimittelgesetz (AMG) and patient's&#xD;
             declaration of Informed Consent in writing, in agreement with Good Clinical Practice&#xD;
             (GCP) and current legal requirements&#xD;
&#xD;
          -  A pain assessment of 3 cm or more on the visual analog scale on at least one of the 2&#xD;
             days immediately preceding the second visit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Painful gastric or intestinal spasms of organic origin such as Crohn's disease,&#xD;
             ulcerative colitis, lactose intolerance&#xD;
&#xD;
          -  Tumour pain/malignant growths&#xD;
&#xD;
          -  Patients with other severe pain states of organic origin (e.g. biliary colic)&#xD;
&#xD;
          -  Mechanical stenoses of the gastrointestinal tract, megacolon&#xD;
&#xD;
          -  Urinary retention associated with mechanical stenoses of the urinary tract (e.g. in&#xD;
             prostate adenoma)&#xD;
&#xD;
          -  Narrow-angle glaucoma&#xD;
&#xD;
          -  Tachyarrhythmia&#xD;
&#xD;
          -  Myasthenia gravis&#xD;
&#xD;
          -  Glucose 6-phosphate dehydrogenase deficiency (danger of haemolytic anaemia)&#xD;
&#xD;
          -  Known hypersensitivity to N-butylscopolammonium bromide or paracetamol&#xD;
&#xD;
          -  Severe liver impairment (e.g. through chronic alcohol abuse, hepatitis):&#xD;
&#xD;
               -  a) Serum-Glutamate-Oxalacetat-Transaminase/ Aspartate Aminotransferase (SGOT)&#xD;
                  higher than four times the norm&#xD;
&#xD;
               -  b) Bilirubin &gt; 3 mg/dl&#xD;
&#xD;
               -  c) Quick's value &lt; 70%&#xD;
&#xD;
          -  Meulengracht-Gilbert syndrome (metabolic disturbance with episodes of jaundice)&#xD;
&#xD;
          -  Severe kidney failure: creatinine &gt; 2 mg/dl&#xD;
&#xD;
          -  Known depression or known mental illness, anxiety disturbance&#xD;
&#xD;
          -  Concomitant intake of analgesics, nonsteroidal antiinflammatory drugs (NSAIDs) and/or&#xD;
             spasmolytics, anticholinergics, nitrates&#xD;
&#xD;
          -  Concomitant medication affecting gastrointestinal motility&#xD;
&#xD;
          -  Regular (daily) use of laxatives&#xD;
&#xD;
          -  Drugs that induce liver enzymes&#xD;
&#xD;
          -  Concomitant administration of chloramphenicol&#xD;
&#xD;
          -  Use of narcotics&#xD;
&#xD;
          -  Antidepressant treatment or treatment with psychoactive drugs&#xD;
&#xD;
          -  Pregnancy and lactation&#xD;
&#xD;
          -  Alcohol abuse (more than 60 g alcohol/day)&#xD;
&#xD;
          -  Frequent vomiting that might prevent adequate absorption of the active ingredient&#xD;
             after the film-coated tablet is taken&#xD;
&#xD;
          -  Patients who are unlikely to be able to keep the examination appointments or cannot&#xD;
             reliably take the study medication regularly&#xD;
&#xD;
          -  Simultaneous participation in another clinical study&#xD;
&#xD;
          -  Patients who are not trained in the VAS (PI) at Visit 1&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</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 28, 2014</study_first_submitted>
  <study_first_submitted_qc>August 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 1, 2014</study_first_posted>
  <last_update_submitted>August 28, 2014</last_update_submitted>
  <last_update_submitted_qc>August 28, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 1, 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>Gastrointestinal Diseases</mesh_term>
    <mesh_term>Digestive System Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acetaminophen</mesh_term>
    <mesh_term>Scopolamine</mesh_term>
    <mesh_term>Butylscopolammonium Bromide</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/NCT02229786
org study id: 218.202
nct id: NCT02229786
lead sponsor: 
Study to evaluate efficacy and tolerability of Buscopan® plus versus Buscopan®, paracetamol,
      and placebo in patients with painful gastric or intestinal spasms.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: Mean decrease in pain intensity on a VAS (visual analog scale)
time frame: 3 weeks
measure: Frequency of pain on a 4-stage verbal rating scale
time frame: up to 4 weeks
measure: Global assessment of efficacy by patient on a 5-point rating scale
time frame: up to 4 weeks
measure: Global assessment of efficacy by investigator on a 5-point rating scale
time frame: up to 4 weeks
measure: Number of patients with adverse events
time frame: up to 4 weeks
arm group label: Buscopan® plus
arm group type: Experimental
arm group label: Buscopan®
arm group type: Active Comparator
arm group label: Paracetamol
arm group type: Active Comparator
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Buscopan® plus
arm group label: Buscopan® plus
intervention type: Drug
intervention name: Buscopan®
arm group label: Buscopan®
intervention type: Drug
intervention name: Paracetamol
arm group label: Paracetamol
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Gastrointestinal Diseases
mesh term: Digestive System Diseases
mesh term: Acetaminophen
mesh term: Scopolamine
mesh term: Butylscopolammonium Bromide