<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/NCT02242292</url>
  </required_header>
  <id_info>
    <org_study_id>202.832</org_study_id>
    <nct_id>NCT02242292</nct_id>
  </id_info>
  <brief_title>Study to Evaluate Efficacy and Safety of Oral Doses of Hyoscine Butylbromide for the Treatment of Occasional Abdominal Pain, Cramping, and Discomfort</brief_title>
  <official_title>A Double-blind, Placebo-controlled, Randomized, Parallel Group Study of the Efficacy and Safety of Oral Doses of 20 mg Hyoscine Butylbromide When Used On-demand up to 7 Episodes Over a Period of 6 Weeks for the Treatment of Occasional Episodes of Self-reported Abdominal Pain, Cramping, and Discomfort Associated With Cramping in an OTC-like Study Population</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 determine whether hyoscine butylbromide can provide adequate symptomatic relief of a&#xD;
      single episode - defined as lasting not longer than 1 day - and multiple episodes of&#xD;
      abdominal pain or discomfort associated with cramping when used as needed&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2006</start_date>
  <primary_completion_date type="Actual">January 2007</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>Response rate in treating the first episode of abdominal pain or discomfort associated with cramping</measure>
    <time_frame>within 24 hours after starting treatment</time_frame>
    <description>(Response was defined as achieving adequate relief of symptoms, as measured on a subject's diary using a dichotomized response to the question)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Response rate to trial medication</measure>
    <time_frame>up to day 41</time_frame>
    <description>responders were those who obtained adequate relief for 50% or more of all treated episodes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of Average symptom relief rated on 4-point scale</measure>
    <time_frame>up to day 41</time_frame>
    <description>based on the &quot;Symptom Relief Index''</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to onset of any effect after the first tablet taken assessed on 5-point scale</measure>
    <time_frame>within 24 hours after starting treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to onset of any effect assessed on 5-point scale</measure>
    <time_frame>up to day 41</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to obtain adequate relief after the first tablet taken assessed on 5-point scale</measure>
    <time_frame>within 24 hours after starting treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to obtain adequate relief assessed on 5-point scale</measure>
    <time_frame>up to day 41</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average time to obtain adequate relief per subject assessed on 5-point scale</measure>
    <time_frame>up to day 41</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average number of tablets taken to treat episodes per subject</measure>
    <time_frame>up to day 41</time_frame>
    <description>measured for each treated episode by the subject's response to the question on the number of tablets taken for each treated episode or 24-hour period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of episodes of diarrhea</measure>
    <time_frame>up to day 41</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of bloating episodes</measure>
    <time_frame>up to day 41</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of constipation episodes</measure>
    <time_frame>up to day 41</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of episodes in relief of abdominal pain or discomfort associated with cramping</measure>
    <time_frame>up to day 41</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global Assessment of efficacy by subject on 4-point scale</measure>
    <time_frame>Day 42</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global Assessment of tolerability by subject on a 4-point scale</measure>
    <time_frame>Day 42</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global assessment of tolerability by investigator on a 4- point scale</measure>
    <time_frame>Day 42</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>up to 42 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with abnormal changes in laboratory parameters</measure>
    <time_frame>up to 42 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">527</enrollment>
  <condition>Colic</condition>
  <arm_group>
    <arm_group_label>Hyoscine butylbromide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>5 tablets taken in a 24-hour period/each episode:&#xD;
for up to 7 episodes, or&#xD;
over a period of up to 6 weeks</description>
  </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>Hyoscine butylbromide</intervention_name>
    <arm_group_label>Hyoscine butylbromide</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;
          1. Adult males and females 18 years of age and older&#xD;
&#xD;
          2. Have at least a 3-month self-reported history of recurrent episodic symptoms, usually&#xD;
             lasting for 1 hour or more, of self-described abdominal pain or discomfort associated&#xD;
             with cramping, which they routinely either have not treated or treated using&#xD;
             Over-the-counter (OTC) medications, in which subjects suffered these symptoms at a&#xD;
             frequency of at least twice monthly to several times weekly, but not on a daily basis.&#xD;
             The episodes of abdominal pain or discomfort may have been associated with other&#xD;
             symptoms of GI dysfunction, such as diarrhea, constipation, and bloating&#xD;
&#xD;
          3. Symptoms typically have a moderate or greater severity (moderate, severe, very severe)&#xD;
             and are sufficiently bothersome to require treatment or intervention&#xD;
&#xD;
          4. Symptoms are not associated with abdominal tenderness, swelling, fever, weight loss,&#xD;
             or passage of blood per rectum. The onset of symptoms may or may not have been&#xD;
             associated with ingestion of food or beverages&#xD;
&#xD;
          5. The episodes of abdominal pain or discomfort may have been associated with other&#xD;
             symptoms of GI dysfunction, such as diarrhea, cramping, constipation, and bloating&#xD;
&#xD;
          6. Subjects are required to be able to comprehend and participate in the activities&#xD;
             required for participation in the trial, to have the ability to attend required site&#xD;
             visits, and to be available and have the facility to participate in a daily telephone&#xD;
             call or computer entry (using a touch-tone phone or computer IVRS entry), which served&#xD;
             as the mechanism for diary entry, during the 6-week course of the study. Subjects were&#xD;
             required to successfully complete an Interactive voice response system (IVRS) training&#xD;
             session prior to entry into the study&#xD;
&#xD;
          7. All subjects completed and signed an informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects who reported having these symptoms for the first time, particularly if they&#xD;
             were 50 years or older, as this may have been a sign of a more serious organic disease&#xD;
&#xD;
          2. Subjects with a known hypersensitivity or allergy to hyoscine butylbromide or any of&#xD;
             the inactive ingredients&#xD;
&#xD;
          3. Subjects who are currently under a physician's care for abdominal symptoms and/or not&#xD;
             using medication or using prescription or OTC medications prescribed by a physician to&#xD;
             treat symptoms of abdominal pain, cramping and discomfort or taking prescription&#xD;
             medication(s) for the treatment of Irritable bowel syndrome (IBS) (Bentyl® or other&#xD;
             antispasmodics, Zelnorm® [tegaserod], Lotronex® [alosetron], prokinetic agents).&#xD;
             Current physician's care was defined as the subject presently following clinician&#xD;
             advice regarding treatment and management of the abdominal pain or discomfort&#xD;
             associated with the cramping symptom&#xD;
&#xD;
          4. Subjects who are having symptoms of abdominal swelling, fever associated with symptoms&#xD;
             of abdominal pain or discomfort associated with cramping, and/or experiencing passage&#xD;
             of blood per rectum associated with symptoms of abdominal pain or discomfort&#xD;
             associated with cramping, or who have any evidence of abdominal tenderness (or any&#xD;
             other evidence of an acute abdomen), abdominal masses, organomegaly or any other&#xD;
             abnormality on abdominal examination&#xD;
&#xD;
          5. Subjects with a history of colon or other GI cancer or malignancy, inflammatory bowel&#xD;
             disease, or Crohn's disease&#xD;
&#xD;
          6. Subjects with chronic constipation&#xD;
&#xD;
          7. Subjects with myasthenia gravis or megacolon&#xD;
&#xD;
          8. Subjects who have undergone abdominal surgery within the past 2 years, having GI&#xD;
             surgery resulting in removal of all or part of the colon, small intestine, or stomach,&#xD;
             or having a history of GI by-pass surgery for weight reduction&#xD;
&#xD;
          9. Prior history of gallbladder removal, appendectomy, and/or surgery for peptic ulcer&#xD;
             disease or gastroesophageal reflux disease (GERD), was not exclusionary.&#xD;
&#xD;
         10. Subjects whose major symptoms were retrosternal burning, acid reflux, acid&#xD;
             regurgitation, or heartburn are excluded&#xD;
&#xD;
         11. Subjects using prescription anticholinergic medications or medications for the&#xD;
             treatment of myasthenia gravis, glaucoma, or ocular hypertension are excluded&#xD;
&#xD;
         12. Subjects who were currently participating in other trials or who participated in a&#xD;
             clinical trial within the prior 30 days are excluded&#xD;
&#xD;
         13. Women who reported being pregnant, are nursing, or who are of child-bearing potential&#xD;
             and not using an adequate method of birth control (medication, device, abstinence,&#xD;
             sterilization for either partner) for 30 days before enrollment and did not agree to&#xD;
             continue using an adequate method of birth control for 30 days after completion of the&#xD;
             trial are excluded&#xD;
&#xD;
         14. Any women of childbearing potential who have a positive serum pregnancy test are&#xD;
             excluded&#xD;
&#xD;
         15. Post-menopausal women who have been post-menopausal for a duration of less than 2&#xD;
             years and did not have a hysterectomy or tubal ligation procedure are excluded&#xD;
&#xD;
         16. Subjects who have tachyarrhythmia (defined as any disturbance of the heart's rhythm,&#xD;
             regular or irregular, resulting in a rate over 100 beats per minute) during a physical&#xD;
             examination are excluded&#xD;
&#xD;
         17. Subjects who have been previously diagnosed with benign prostatic hyperplasia (BPH) or&#xD;
             subjects who experienced urinary retention are excluded&#xD;
&#xD;
         18. Subjects with clinically significant cardiovascular disease in the opinion of the&#xD;
             investigator (including hypotension, hypertension, severe coronary artery disease,&#xD;
             congestive heart failure, angina pectoris) are excluded&#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>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/16817918</url>
    <description>Related Info</description>
  </link>
  <verification_date>December 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>
  <last_update_submitted>December 27, 2017</last_update_submitted>
  <last_update_submitted_qc>December 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 28, 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>
  <!-- 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/NCT02242292
org study id: 202.832
nct id: NCT02242292
lead sponsor: 
Study to determine whether hyoscine butylbromide can provide adequate symptomatic relief of a
      single episode - defined as lasting not longer than 1 day - and multiple episodes of
      abdominal pain or discomfort associated with cramping when used as needed
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: Response rate in treating the first episode of abdominal pain or discomfort associated with cramping
time frame: within 24 hours after starting treatment
description: (Response was defined as achieving adequate relief of symptoms, as measured on a subject's diary using a dichotomized response to the question)
measure: Response rate to trial medication
time frame: up to day 41
description: responders were those who obtained adequate relief for 50% or more of all treated episodes
measure: Assessment of Average symptom relief rated on 4-point scale
time frame: up to day 41
description: based on the "Symptom Relief Index''
measure: Time to onset of any effect after the first tablet taken assessed on 5-point scale
time frame: within 24 hours after starting treatment
measure: Time to onset of any effect assessed on 5-point scale
time frame: up to day 41
measure: Time to obtain adequate relief after the first tablet taken assessed on 5-point scale
time frame: within 24 hours after starting treatment
measure: Time to obtain adequate relief assessed on 5-point scale
time frame: up to day 41
measure: Average time to obtain adequate relief per subject assessed on 5-point scale
time frame: up to day 41
measure: Average number of tablets taken to treat episodes per subject
time frame: up to day 41
description: measured for each treated episode by the subject's response to the question on the number of tablets taken for each treated episode or 24-hour period
measure: Percentage of episodes of diarrhea
time frame: up to day 41
measure: Percentage of bloating episodes
time frame: up to day 41
measure: Percentage of constipation episodes
time frame: up to day 41
measure: Percentage of episodes in relief of abdominal pain or discomfort associated with cramping
time frame: up to day 41
measure: Global Assessment of efficacy by subject on 4-point scale
time frame: Day 42
measure: Global Assessment of tolerability by subject on a 4-point scale
time frame: Day 42
measure: Global assessment of tolerability by investigator on a 4- point scale
time frame: Day 42
measure: Number of patients with adverse events
time frame: up to 42 days
measure: Number of patients with abnormal changes in laboratory parameters
time frame: up to 42 days
arm group label: Hyoscine butylbromide
arm group type: Experimental
description: 5 tablets taken in a 24-hour period/each episode:
for up to 7 episodes, or
over a period of up to 6 weeks
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Hyoscine butylbromide
arm group label: Hyoscine butylbromide
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
url: http://trials.boehringer-ingelheim.com
description: Related Info
url: https://www.ncbi.nlm.nih.gov/pubmed/16817918
description: Related Info
responsible party type: Sponsor
mesh term: Abdominal Pain
mesh term: Scopolamine
mesh term: Butylscopolammonium Bromide