<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/NCT02242305</url>
  </required_header>
  <id_info>
    <org_study_id>202.838</org_study_id>
    <nct_id>NCT02242305</nct_id>
  </id_info>
  <brief_title>Study to Evaluate the Efficacy and Safety of Hyoscine Butylbromide Tablets for the Treatment of Occasional or Recurrent Episodes of Gastric or Intestinal Spasm-like Pain or Discomfort</brief_title>
  <official_title>A Randomized, Double-blind, Double-dummy, Active-controlled, Parallel-group, Multi-center Trial, in Contrast With Hyoscine Butylbromide Capsule 10mg, to Evaluate the Efficacy and Safety of Hyoscine Butylbromide Tablets 10 mg (20mg, 3 Times Daily, Orally) Over a Period of 3 Days for the Treatment of Occasional or Recurrent Episodes of Self-reported Gastric or Intestinal Spasm-like Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      In contrast with Hyoscine Butylbromide Capsule 10mg, Study is to evaluate the efficacy and&#xD;
      safety of Hyoscine Butylbromide tablets 10 mg (20mg, 3 times daily, orally) over a period of&#xD;
      3 days for the treatment of occasional or recurrent episodes of self-reported gastric or&#xD;
      intestinal spasm-like pain or discomfort&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2008</start_date>
  <completion_date type="Actual">July 20, 2009</completion_date>
  <primary_completion_date type="Actual">July 20, 2009</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of the Mean Pain Intensity Score Measured on a Visual Analogue Scale (VAS) Within 3 Days (and Within 1 Day) - ANCOVA</measure>
    <time_frame>3 days (1 day)</time_frame>
    <description>The endpoint presents change of the mean Visual Analogue Scale (VAS) of pain intensity score, recorded daily by the patient in the evening in his/her patient diary describing pain intensity during the previous 24 hours, from the baseline pain intensity. The baseline pain intensity was the pain intensity of first episode on Day 1 after randomization before taking study medication. The mean VAS pain intensity score was calculated for the 3-day treatment period. A VAS for describing the pain intensity was used (VAS: maximum score of 10 cm, the score from 0 - 10 cm reaching from &quot;no pain&quot; to &quot;the most severe pain imaginable&quot;).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of the Pain Frequency Assessed on 4-stage Verbal Rating Scale (VRS)</measure>
    <time_frame>Up to 3 days.</time_frame>
    <description>The endpoint presents frequency improvement, change of the pain frequency from baseline pain frequency for each of Day 1 - 3. Baseline pain frequency meant the pain frequency before randomization on visit 1. VRS score of Day 3 change from baseline was calculated. A retrospective assessment was entered by the patient in the patient diary, again once daily in the evening, of the pain frequency over the preceding 24 hour period. This was based on a 4-stage Verbal Rating Scale (VRS) with the following scores to the question: &quot;How many times have the spasm-like pains occurred today?&quot; 0 = not at all, 1 = 1-2 times, 2 = 3-5 times, 3 = more than 5 times.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global Assessment of Efficacy by Patient on 4-point Scale</measure>
    <time_frame>Post 3 days of treatment.</time_frame>
    <description>The endpoint presents global assessment of efficacy: by the patient after 3 days of treatment using a 4-point rating scale (good, satisfactory, not satisfactory, and bad).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients With Adverse Events</measure>
    <time_frame>Up to 3 days.</time_frame>
    <description>The endpoint presents number of patients with Adverse Events (AEs). Subjects were required to report spontaneously any AEs as well as the time of onset, end and intensity of these events. Specific questions were asked wherever required or useful to more precisely describe an AE. An Adverse Event was termed serious when one of the following applied: death, directly lifethreatening, continuous or severe impairment, in-patient treatment or prolonging of hospitalization, congenital deformity and other similar medical criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global Assessment of Tolerability by Investigator on a 4-point Scale</measure>
    <time_frame>Day 3.</time_frame>
    <description>The endpoint presents global assessment of tolerability by subject on a 4-point scale. Global assessment of tolerability regarding all episodes treated by the subject after 3 days of treatment (good, satisfactory, not satisfactory, bad).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Clinical Relevant Abnormalities for Laboratory, Vital Signs, ElectroCardioGram (ECG) and Physical Examination</measure>
    <time_frame>Up to 3 days.</time_frame>
    <description>Number of patients with findings in clinical relevant abnormalities for laboratory, vital signs, ElectroCardioGram (ECG) and physical examination. Relevant findings or worsening of baseline conditions were reported as Adverse Events (AEs).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Event for Time to Therapeutic Effect</measure>
    <time_frame>From time of the first dose to the time that the first VAS reduction occurred, up to 180 minutes after the first dose on Day 1.</time_frame>
    <description>This outcome measure presents percentage of event for time to therapeutic effect defined as the time that the first VAS reduction occurred.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">302</enrollment>
  <condition>Abdominal Pain</condition>
  <arm_group>
    <arm_group_label>Hyoscine Butylbromide - Tablet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Hyoscine Butylbromide - Capsule</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hyoscine Butylbromide - Tablet</intervention_name>
    <arm_group_label>Hyoscine Butylbromide - Tablet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hyoscine Butylbromide - Capsule</intervention_name>
    <arm_group_label>Hyoscine Butylbromide - Capsule</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Hyoscine Butylbromide - Capsule</arm_group_label>
    <arm_group_label>Hyoscine Butylbromide - Tablet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Written Informed Consent given by the patient&#xD;
&#xD;
          2. Male and female patients aging from 18 to 70&#xD;
&#xD;
          3. Subjects with occasional or recurrent episodes of gastric or intestinal spasm-like&#xD;
             pain, or discomfort, such as occur e.g. in irritable bowel syndrome, which has been&#xD;
             present for at least 3 months&#xD;
&#xD;
          4. The pain intensity score upon screening is at least 4 cm in VAS score&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with the following concomitant disease were not eligible for enrolment&#xD;
&#xD;
               -  Painful gastric or intestinal spasm of organic origin such as Crohn's disease,&#xD;
                  ulcerative colitis, lactose intolerance, gastritis, ulcer. Exception:&#xD;
                  diverticulitis and mild gastritis if dominant symptom was cramp pain, but&#xD;
                  ineligible if heartburn or reflux were dominant symptoms&#xD;
&#xD;
               -  Pain related with malignancy&#xD;
&#xD;
               -  Patients with other severe pain states of organic origin&#xD;
&#xD;
               -  Mechanical stenosis of the gastrointestinal tract, megacolon&#xD;
&#xD;
               -  Urinary retention associated with mechanical stenosis of urinary tract&#xD;
&#xD;
               -  Narrow-angled glaucoma&#xD;
&#xD;
               -  Tachyarrhythmia&#xD;
&#xD;
               -  Myasthenia gravis&#xD;
&#xD;
               -  Meulengracht-Gilbert syndrome&#xD;
&#xD;
               -  Known depression or known mental illness, anxiety disturbance&#xD;
&#xD;
          2. Frequent vomiting that might have prevented adequate absorption of the active&#xD;
             ingredient after the film-coated tablet was taken&#xD;
&#xD;
          3. Patients taking the following concomitant medication are not eligible for enrolment&#xD;
&#xD;
               -  Analgesics&#xD;
&#xD;
               -  Spasmolytics&#xD;
&#xD;
               -  Anticholinergics&#xD;
&#xD;
               -  Affecting gastrointestinal motility, such as propantheline metoclopramide,&#xD;
                  cisapride, loperamide, diphenoxylate, opioid analgesics, antacids and other ulcer&#xD;
                  treatment&#xD;
&#xD;
               -  Regular administration of laxatives&#xD;
&#xD;
               -  Narcotics&#xD;
&#xD;
               -  Antidepressant treatment or treatment with psychoactive drugs&#xD;
&#xD;
          4. Pregnancy and/or lactation or planned pregnancy&#xD;
&#xD;
          5. Known hypersensitivity to N-butylscopolammonium bromide&#xD;
&#xD;
          6. Alcohol or drug abuse&#xD;
&#xD;
          7. Simultaneous participating in another clinical trial, or discontinuing from another&#xD;
             clinical trial before randomization (administration of study medication); moreover, in&#xD;
             the case of screening failure or premature discontinuing from the trial, repeated&#xD;
             enrolment is forbidden&#xD;
&#xD;
          8. Unwilling to or unable to complete the entire trial procedure according to the&#xD;
             protocol&#xD;
&#xD;
          9. In investigator's opinion, the patient was not proper for the trial&#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>July 2017</verification_date>
  <study_first_submitted>September 16, 2014</study_first_submitted>
  <study_first_submitted_qc>September 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2014</study_first_posted>
  <results_first_submitted>March 29, 2017</results_first_submitted>
  <results_first_submitted_qc>July 26, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">July 27, 2017</results_first_posted>
  <last_update_submitted>July 26, 2017</last_update_submitted>
  <last_update_submitted_qc>July 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2017</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>Abdominal Pain</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Scopolamine</mesh_term>
    <mesh_term>Butylscopolammonium Bromide</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Hyoscine Butylbromide - Tablet (Tab.)</title>
          <description>The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Buscopan) sugar coated tablet 20 mg orally, 3 times daily for 3 days.</description>
        </group>
        <group group_id="P2">
          <title>Hyoscine Butylbromide - Capsule (Cap.)</title>
          <description>The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Jie Jing Ning) sugar coated capsule 20 mg orally, 3 times daily for 3 days.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="151"/>
                <participants group_id="P2" count="151"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="145"/>
                <participants group_id="P2" count="141"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Without spasm-like pain during 3 weeks</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Non-compliance dosing regimen or visit</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Subject withdraws inform consent</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Full Analysis Set (FAS): According to the Intent-to-Treat (ITT) principle, all randomized subjects who took at least one dose of study medication and who provided any data for the primary efficacy endpoint were used in FAS.&#xD;
Baseline participants less than participant flow as no abdominal pain within 3 weeks following randomization were withdrawn.</population>
      <group_list>
        <group group_id="B1">
          <title>Hyoscine Butylbromide - Tablet</title>
          <description>The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Buscopan) sugar coated tablet 20 mg orally, 3 times daily for 3 days.</description>
        </group>
        <group group_id="B2">
          <title>Hyoscine Butylbromide - Capsule</title>
          <description>The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Jie Jing Ning) sugar coated capsule 20 mg orally, 3 times daily for 3 days.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="146"/>
            <count group_id="B2" value="142"/>
            <count group_id="B3" value="288"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="43.2" spread="12.49"/>
                    <measurement group_id="B2" value="41.9" spread="12.05"/>
                    <measurement group_id="B3" value="42.6" spread="12.27"/>
                  </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="89"/>
                    <measurement group_id="B2" value="84"/>
                    <measurement group_id="B3" value="173"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="57"/>
                    <measurement group_id="B2" value="58"/>
                    <measurement group_id="B3" value="115"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change of the Mean Pain Intensity Score Measured on a Visual Analogue Scale (VAS) Within 3 Days (and Within 1 Day) - ANCOVA</title>
        <description>The endpoint presents change of the mean Visual Analogue Scale (VAS) of pain intensity score, recorded daily by the patient in the evening in his/her patient diary describing pain intensity during the previous 24 hours, from the baseline pain intensity. The baseline pain intensity was the pain intensity of first episode on Day 1 after randomization before taking study medication. The mean VAS pain intensity score was calculated for the 3-day treatment period. A VAS for describing the pain intensity was used (VAS: maximum score of 10 cm, the score from 0 - 10 cm reaching from &quot;no pain&quot; to &quot;the most severe pain imaginable&quot;).</description>
        <time_frame>3 days (1 day)</time_frame>
        <population>Per-Protocol Set (PPS): All randomized subjects in FAS without any major protocol violation were included into the per protocol set, including those subjects who had good treatment compliance (80% to 120%), who did not take any restriction medications during the study period and whose Case Report Form (CRF) was complete as requested.</population>
        <group_list>
          <group group_id="O1">
            <title>Hyoscine Butylbromide - Tablet</title>
            <description>The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Buscopan) sugar coated tablet 20 mg orally, 3 times daily for 3 days.</description>
          </group>
          <group group_id="O2">
            <title>Hyoscine Butylbromide - Capsule</title>
            <description>The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Jie Jing Ning) sugar coated capsule 20 mg orally, 3 times daily for 3 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Change of the Mean Pain Intensity Score Measured on a Visual Analogue Scale (VAS) Within 3 Days (and Within 1 Day) - ANCOVA</title>
          <description>The endpoint presents change of the mean Visual Analogue Scale (VAS) of pain intensity score, recorded daily by the patient in the evening in his/her patient diary describing pain intensity during the previous 24 hours, from the baseline pain intensity. The baseline pain intensity was the pain intensity of first episode on Day 1 after randomization before taking study medication. The mean VAS pain intensity score was calculated for the 3-day treatment period. A VAS for describing the pain intensity was used (VAS: maximum score of 10 cm, the score from 0 - 10 cm reaching from &quot;no pain&quot; to &quot;the most severe pain imaginable&quot;).</description>
          <population>Per-Protocol Set (PPS): All randomized subjects in FAS without any major protocol violation were included into the per protocol set, including those subjects who had good treatment compliance (80% to 120%), who did not take any restriction medications during the study period and whose Case Report Form (CRF) was complete as requested.</population>
          <units>Units on a scale</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="141"/>
                <count group_id="O2" value="140"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Within 3 days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.48" spread="1.968"/>
                    <measurement group_id="O2" value="-2.45" spread="1.879"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Within 1 day</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.36" spread="1.984"/>
                    <measurement group_id="O2" value="-2.31" spread="1.914"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.809</p_value>
            <method>ANCOVA</method>
            <method_desc>Analysis of Covariance (ANCOVA) model including treatment and center as fixed effects and baseline pain intensity as a covariate was used.</method_desc>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.03</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.33</ci_lower_limit>
            <ci_upper_limit>0.27</ci_upper_limit>
            <estimate_desc>Treatment differences were estimated by reference to the Least Squares (LS) mean differences within 3 days and the corresponding 90% CIs. The mean difference calculated as Hyoscine Butylbromide tablets 10 mg - Hyoscine Butylbromide capsules 10 mg.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.809</p_value>
            <method>ANCOVA</method>
            <method_desc>Analysis of Covariance (ANCOVA) model including treatment and center as fixed effects and baseline pain intensity as a covariate was used.</method_desc>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>-0.05</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.39</ci_lower_limit>
            <ci_upper_limit>0.33</ci_upper_limit>
            <estimate_desc>Treatment differences were estimated by reference to the Least Squares (LS) mean differences within 1 day and the corresponding 90% CIs. The mean difference calculated as Hyoscine Butylbromide tablets 10 mg - Hyoscine Butylbromide capsules 10 mg.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change of the Pain Frequency Assessed on 4-stage Verbal Rating Scale (VRS)</title>
        <description>The endpoint presents frequency improvement, change of the pain frequency from baseline pain frequency for each of Day 1 - 3. Baseline pain frequency meant the pain frequency before randomization on visit 1. VRS score of Day 3 change from baseline was calculated. A retrospective assessment was entered by the patient in the patient diary, again once daily in the evening, of the pain frequency over the preceding 24 hour period. This was based on a 4-stage Verbal Rating Scale (VRS) with the following scores to the question: &quot;How many times have the spasm-like pains occurred today?&quot; 0 = not at all, 1 = 1-2 times, 2 = 3-5 times, 3 = more than 5 times.</description>
        <time_frame>Up to 3 days.</time_frame>
        <population>Per-Protocol Set (PPS): All randomized subjects in FAS without any major protocol violation were included into the per protocol set, including those subjects who had good treatment compliance (80% to 120%), who did not take any restriction medications during the study period and whose Case Report Form (CRF) was complete as requested.</population>
        <group_list>
          <group group_id="O1">
            <title>Hyoscine Butylbromide - Tablet</title>
            <description>The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Buscopan) sugar coated tablet 20 mg orally, 3 times daily for 3 days.</description>
          </group>
          <group group_id="O2">
            <title>Hyoscine Butylbromide - Capsule</title>
            <description>The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Jie Jing Ning) sugar coated capsule 20 mg orally, 3 times daily for 3 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Change of the Pain Frequency Assessed on 4-stage Verbal Rating Scale (VRS)</title>
          <description>The endpoint presents frequency improvement, change of the pain frequency from baseline pain frequency for each of Day 1 - 3. Baseline pain frequency meant the pain frequency before randomization on visit 1. VRS score of Day 3 change from baseline was calculated. A retrospective assessment was entered by the patient in the patient diary, again once daily in the evening, of the pain frequency over the preceding 24 hour period. This was based on a 4-stage Verbal Rating Scale (VRS) with the following scores to the question: &quot;How many times have the spasm-like pains occurred today?&quot; 0 = not at all, 1 = 1-2 times, 2 = 3-5 times, 3 = more than 5 times.</description>
          <population>Per-Protocol Set (PPS): All randomized subjects in FAS without any major protocol violation were included into the per protocol set, including those subjects who had good treatment compliance (80% to 120%), who did not take any restriction medications during the study period and whose Case Report Form (CRF) was complete as requested.</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="141"/>
                <count group_id="O2" value="140"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1-Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.4" spread="0.77"/>
                    <measurement group_id="O2" value="-0.2" spread="0.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3-Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.0" spread="0.94"/>
                    <measurement group_id="O2" value="-0.8" spread="0.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.079</p_value>
            <method>ANCOVA</method>
            <method_desc>Analysis of Covariance (ANCOVA) model including treatment and center as fixed effects and baseline pain intensity as a covariate was used.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Global Assessment of Efficacy by Patient on 4-point Scale</title>
        <description>The endpoint presents global assessment of efficacy: by the patient after 3 days of treatment using a 4-point rating scale (good, satisfactory, not satisfactory, and bad).</description>
        <time_frame>Post 3 days of treatment.</time_frame>
        <population>Full Analysis Set (FAS): According to the Intent-to-Treat (ITT) principle, all randomized subjects who took at least one dose of study medication and who provided any data for the primary efficacy endpoint were used in FAS.</population>
        <group_list>
          <group group_id="O1">
            <title>Hyoscine Butylbromide - Tablet</title>
            <description>The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Buscopan) sugar coated tablet 20 mg orally, 3 times daily for 3 days.</description>
          </group>
          <group group_id="O2">
            <title>Hyoscine Butylbromide - Capsule</title>
            <description>The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Jie Jing Ning) sugar coated capsule 20 mg orally, 3 times daily for 3 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Global Assessment of Efficacy by Patient on 4-point Scale</title>
          <description>The endpoint presents global assessment of efficacy: by the patient after 3 days of treatment using a 4-point rating scale (good, satisfactory, not satisfactory, and bad).</description>
          <population>Full Analysis Set (FAS): According to the Intent-to-Treat (ITT) principle, all randomized subjects who took at least one dose of study medication and who provided any data for the primary efficacy endpoint were used in FAS.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="143"/>
                <count group_id="O2" value="141"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Good</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                    <measurement group_id="O2" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Satisfactory</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69"/>
                    <measurement group_id="O2" value="76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not satisfactory</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37"/>
                    <measurement group_id="O2" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bad</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients With Adverse Events</title>
        <description>The endpoint presents number of patients with Adverse Events (AEs). Subjects were required to report spontaneously any AEs as well as the time of onset, end and intensity of these events. Specific questions were asked wherever required or useful to more precisely describe an AE. An Adverse Event was termed serious when one of the following applied: death, directly lifethreatening, continuous or severe impairment, in-patient treatment or prolonging of hospitalization, congenital deformity and other similar medical criteria.</description>
        <time_frame>Up to 3 days.</time_frame>
        <population>Safety Set (SFS): All randomized subjects who took at least one dose of study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Hyoscine Butylbromide - Tablet</title>
            <description>The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Buscopan) sugar coated tablet 20 mg orally, 3 times daily for 3 days.</description>
          </group>
          <group group_id="O2">
            <title>Hyoscine Butylbromide - Capsule</title>
            <description>The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Jie Jing Ning) sugar coated capsule 20 mg orally, 3 times daily for 3 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With Adverse Events</title>
          <description>The endpoint presents number of patients with Adverse Events (AEs). Subjects were required to report spontaneously any AEs as well as the time of onset, end and intensity of these events. Specific questions were asked wherever required or useful to more precisely describe an AE. An Adverse Event was termed serious when one of the following applied: death, directly lifethreatening, continuous or severe impairment, in-patient treatment or prolonging of hospitalization, congenital deformity and other similar medical criteria.</description>
          <population>Safety Set (SFS): All randomized subjects who took at least one dose of study medication.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="146"/>
                <count group_id="O2" value="142"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Subjects with AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subjects with treatment related AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subjects with Serious Adverse Event (SAE)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AE leading to discontinuation from treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subjects with AE: Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subjects with AE: Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subjects with AE: Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Global Assessment of Tolerability by Investigator on a 4-point Scale</title>
        <description>The endpoint presents global assessment of tolerability by subject on a 4-point scale. Global assessment of tolerability regarding all episodes treated by the subject after 3 days of treatment (good, satisfactory, not satisfactory, bad).</description>
        <time_frame>Day 3.</time_frame>
        <population>Safety Set (SFS): All randomized subjects who took at least one dose of study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Hyoscine Butylbromide - Tablet</title>
            <description>The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Buscopan) sugar coated tablet 20 mg orally, 3 times daily for 3 days.</description>
          </group>
          <group group_id="O2">
            <title>Hyoscine Butylbromide - Capsule</title>
            <description>The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Jie Jing Ning) sugar coated capsule 20 mg orally, 3 times daily for 3 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Global Assessment of Tolerability by Investigator on a 4-point Scale</title>
          <description>The endpoint presents global assessment of tolerability by subject on a 4-point scale. Global assessment of tolerability regarding all episodes treated by the subject after 3 days of treatment (good, satisfactory, not satisfactory, bad).</description>
          <population>Safety Set (SFS): All randomized subjects who took at least one dose of study medication.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="145"/>
                <count group_id="O2" value="141"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Good</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51"/>
                    <measurement group_id="O2" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Satisfactory</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72"/>
                    <measurement group_id="O2" value="72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not satisfactory</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bad</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Clinical Relevant Abnormalities for Laboratory, Vital Signs, ElectroCardioGram (ECG) and Physical Examination</title>
        <description>Number of patients with findings in clinical relevant abnormalities for laboratory, vital signs, ElectroCardioGram (ECG) and physical examination. Relevant findings or worsening of baseline conditions were reported as Adverse Events (AEs).</description>
        <time_frame>Up to 3 days.</time_frame>
        <population>Safety Set (SFS): All randomized subjects who took at least one dose of study medication.</population>
        <group_list>
          <group group_id="O1">
            <title>Hyoscine Butylbromide - Tablet</title>
            <description>The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Buscopan) sugar coated tablet 20 mg orally, 3 times daily for 3 days.</description>
          </group>
          <group group_id="O2">
            <title>Hyoscine Butylbromide - Capsule</title>
            <description>The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Jie Jing Ning) sugar coated capsule 20 mg orally, 3 times daily for 3 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Clinical Relevant Abnormalities for Laboratory, Vital Signs, ElectroCardioGram (ECG) and Physical Examination</title>
          <description>Number of patients with findings in clinical relevant abnormalities for laboratory, vital signs, ElectroCardioGram (ECG) and physical examination. Relevant findings or worsening of baseline conditions were reported as Adverse Events (AEs).</description>
          <population>Safety Set (SFS): All randomized subjects who took at least one dose of study medication.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="146"/>
                <count group_id="O2" value="142"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Urinary White Bllood Cell count abnormalities</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urinary Red Blood Cell count abnormalities</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urinary albumin abnormalities</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White Blood Cell count abnormalities</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelet count abnormalities</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Event for Time to Therapeutic Effect</title>
        <description>This outcome measure presents percentage of event for time to therapeutic effect defined as the time that the first VAS reduction occurred.</description>
        <time_frame>From time of the first dose to the time that the first VAS reduction occurred, up to 180 minutes after the first dose on Day 1.</time_frame>
        <population>Per-Protocol Set (PPS): All randomized subjects in FAS without any major protocol violation were included into the per protocol set, including those subjects who had good treatment compliance (80% to 120%), who did not take any restriction medications during the study period and whose Case Report Form (CRF) was complete as requested.</population>
        <group_list>
          <group group_id="O1">
            <title>Hyoscine Butylbromide - Tablet</title>
            <description>The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Buscopan) sugar coated tablet 20 mg orally, 3 times daily for 3 days.</description>
          </group>
          <group group_id="O2">
            <title>Hyoscine Butylbromide - Capsule</title>
            <description>The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Jie Jing Ning) sugar coated capsule 20 mg orally, 3 times daily for 3 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Event for Time to Therapeutic Effect</title>
          <description>This outcome measure presents percentage of event for time to therapeutic effect defined as the time that the first VAS reduction occurred.</description>
          <population>Per-Protocol Set (PPS): All randomized subjects in FAS without any major protocol violation were included into the per protocol set, including those subjects who had good treatment compliance (80% to 120%), who did not take any restriction medications during the study period and whose Case Report Form (CRF) was complete as requested.</population>
          <units>Percentage of event</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="141"/>
                <count group_id="O2" value="140"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.6" lower_limit="NA" upper_limit="NA"/>
                    <measurement group_id="O2" value="92.1" lower_limit="NA" upper_limit="NA"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.531</p_value>
            <method>ANCOVA</method>
            <method_desc>Analysis of Covariance (ANCOVA) model including treatment and center as fixed effects and baseline score as covariates was used.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From first drug administration until 3 days after last drug administration, up to 284 days.</time_frame>
      <desc>The total number of participants at Risk is from SFS [Safety Set] which was different from efficacy set PPS [Per-Protocol Set] and ITT [Intent-to-Treat].</desc>
      <group_list>
        <group group_id="E1">
          <title>Hyoscine Butylbromide - Tablet</title>
          <description>The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Buscopan) sugar coated tablet 20 mg orally, 3 times daily for 3 days.</description>
        </group>
        <group group_id="E2">
          <title>Hyoscine Butylbromide - Capsule</title>
          <description>The subjects administered Hyoscine Butylbromide (10 mg), (Brand name: Jie Jing Ning) sugar coated capsule 20 mg orally, 3 times daily for 3 days.</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="146"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="142"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="146"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="142"/>
              </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>Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Boehringer Ingelheim, Call Center</name_or_title>
      <organization>Boehringer Ingelheim</organization>
      <phone>1800-243-0127</phone>
      <email>clintriage.rdg@boehringer-ingelheim.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/NCT02242305
org study id: 202.838
nct id: NCT02242305
lead sponsor: 
In contrast with Hyoscine Butylbromide Capsule 10mg, Study is to evaluate the efficacy and
      safety of Hyoscine Butylbromide tablets 10 mg (20mg, 3 times daily, orally) over a period of
      3 days for the treatment of occasional or recurrent episodes of self-reported gastric or
      intestinal spasm-like pain or discomfort
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change of the Mean Pain Intensity Score Measured on a Visual Analogue Scale (VAS) Within 3 Days (and Within 1 Day) - ANCOVA
time frame: 3 days (1 day)
description: The endpoint presents change of the mean Visual Analogue Scale (VAS) of pain intensity score, recorded daily by the patient in the evening in his/her patient diary describing pain intensity during the previous 24 hours, from the baseline pain intensity. The baseline pain intensity was the pain intensity of first episode on Day 1 after randomization before taking study medication. The mean VAS pain intensity score was calculated for the 3-day treatment period. A VAS for describing the pain intensity was used (VAS: maximum score of 10 cm, the score from 0 - 10 cm reaching from "no pain" to "the most severe pain imaginable").
measure: Change of the Pain Frequency Assessed on 4-stage Verbal Rating Scale (VRS)
time frame: Up to 3 days.
description: The endpoint presents frequency improvement, change of the pain frequency from baseline pain frequency for each of Day 1 - 3. Baseline pain frequency meant the pain frequency before randomization on visit 1. VRS score of Day 3 change from baseline was calculated. A retrospective assessment was entered by the patient in the patient diary, again once daily in the evening, of the pain frequency over the preceding 24 hour period. This was based on a 4-stage Verbal Rating Scale (VRS) with the following scores to the question: "How many times have the spasm-like pains occurred today?" 0 = not at all, 1 = 1-2 times, 2 = 3-5 times, 3 = more than 5 times.
measure: Global Assessment of Efficacy by Patient on 4-point Scale
time frame: Post 3 days of treatment.
description: The endpoint presents global assessment of efficacy: by the patient after 3 days of treatment using a 4-point rating scale (good, satisfactory, not satisfactory, and bad).
measure: Number of Patients With Adverse Events
time frame: Up to 3 days.
description: The endpoint presents number of patients with Adverse Events (AEs). Subjects were required to report spontaneously any AEs as well as the time of onset, end and intensity of these events. Specific questions were asked wherever required or useful to more precisely describe an AE. An Adverse Event was termed serious when one of the following applied: death, directly lifethreatening, continuous or severe impairment, in-patient treatment or prolonging of hospitalization, congenital deformity and other similar medical criteria.
measure: Global Assessment of Tolerability by Investigator on a 4-point Scale
time frame: Day 3.
description: The endpoint presents global assessment of tolerability by subject on a 4-point scale. Global assessment of tolerability regarding all episodes treated by the subject after 3 days of treatment (good, satisfactory, not satisfactory, bad).
measure: Number of Subjects With Clinical Relevant Abnormalities for Laboratory, Vital Signs, ElectroCardioGram (ECG) and Physical Examination
time frame: Up to 3 days.
description: Number of patients with findings in clinical relevant abnormalities for laboratory, vital signs, ElectroCardioGram (ECG) and physical examination. Relevant findings or worsening of baseline conditions were reported as Adverse Events (AEs).
measure: Percentage of Event for Time to Therapeutic Effect
time frame: From time of the first dose to the time that the first VAS reduction occurred, up to 180 minutes after the first dose on Day 1.
description: This outcome measure presents percentage of event for time to therapeutic effect defined as the time that the first VAS reduction occurred.
arm group label: Hyoscine Butylbromide - Tablet
arm group type: Experimental
arm group label: Hyoscine Butylbromide - Capsule
arm group type: Active Comparator
intervention type: Drug
intervention name: Hyoscine Butylbromide - Tablet
arm group label: Hyoscine Butylbromide - Tablet
intervention type: Drug
intervention name: Hyoscine Butylbromide - Capsule
arm group label: Hyoscine Butylbromide - Capsule
intervention type: Drug
intervention name: Placebo
arm group label: Hyoscine Butylbromide - Capsule
arm group label: Hyoscine Butylbromide - Tablet
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: Abdominal Pain
mesh term: Scopolamine
mesh term: Butylscopolammonium Bromide
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 