<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/NCT01726270</url>
  </required_header>
  <id_info>
    <org_study_id>527.82</org_study_id>
    <nct_id>NCT01726270</nct_id>
  </id_info>
  <brief_title>An 8-week, Open-label, Uncontrolled Study of Tamsulosin 0.4mg in Men With Bothersome Urinary Symptoms</brief_title>
  <official_title>A 8-week, Open-label, Uncontrolled, Exploratory Actual Use Study of Tamsulosin 0.4mg in Men With Prostate Urinary Symptoms in a Simulated Over-the-Counter Environment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      Multicenter trial conducted in Pharmacy retail centers&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">March 2013</completion_date>
  <primary_completion_date type="Actual">March 2013</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants Who Appropriately Followed the Label Instructions</measure>
    <time_frame>8 weeks</time_frame>
    <description>Includes subjects who reported:&#xD;
No improvement in urinary symptoms and stopped taking product,&#xD;
Reported worsening of urinary symptoms and stopped taking the product,&#xD;
Reported a new urinary symptom and stopped taking the product,&#xD;
Reported no &quot;Stop Use&quot; condition and never took more than 1 capsule on any given day,&#xD;
Reported a &quot;Stop Use&quot; condition and contacted a provider.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Took no More Than One Capsule Per Day</measure>
    <time_frame>8 weeks</time_frame>
    <description>Percentage of participants who took no more than one capsule per day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of &quot;Use-Days&quot; for All Participants Who Took no More Than One Capsule Per Day</measure>
    <time_frame>8 weeks</time_frame>
    <description>&quot;Use-day&quot; was defind as a calendar day for which data were available regarding use or non-use.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants &lt; 45 Years of Age Who Spoke to a Doctor During the Actual Use Phase</measure>
    <time_frame>8 weeks</time_frame>
    <description>Includes participants who:&#xD;
were less than 45 years of age at enrollment, and&#xD;
spoke to a doctor during the actual use phase.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Are Potentially at Risk of Harm by Incorrectly Selecting to Use the Study Product Out of the Total Study Population</measure>
    <time_frame>8 weeks</time_frame>
    <description>Percentage of participants who are potentially at risk of harm by incorrectly selecting to use the study product out of the total study population</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Have a Correct Self-selection Response Out of the Total Study Population</measure>
    <time_frame>8 weeks</time_frame>
    <description>Percentage of participants who have a correct self-selection response as defined by the &quot;Uses&quot;, &quot;Allergy alert&quot;, and &quot;Do Not Use&quot; sections of the Drug Facts Label.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">689</enrollment>
  <condition>Lower Urinary Tract Symptoms</condition>
  <arm_group>
    <arm_group_label>tamsulosin hydrochloride</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients will take drug for 8 weeks in this exploratory study</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>tamsulosin</intervention_name>
    <description>0.4 mg</description>
    <arm_group_label>tamsulosin hydrochloride</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          1. Men 18 years of age and older.&#xD;
&#xD;
          2. Able to speak, read and understand English.&#xD;
&#xD;
          3. Willing to participate in the study and voluntarily sign an informed consent document.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        1. Subject or anyone in their household is currently employed by a marketing or marketing&#xD;
        research company, and advertising agency or public relations firm, a pharmacy or&#xD;
        pharmaceutical company, a manufacturer of medicines, a managed care or health insurance&#xD;
        company as a healthcare professional or healthcare practice.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Boehringer Ingelheim</last_name>
    <role>Study Chair</role>
    <affiliation>Boehringer Ingelheim</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Hoover</city>
        <state>Alabama</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Mesa</city>
        <state>Arizona</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Encino</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Garden Grove</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>La Habra</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Anoka</city>
        <state>Minnesota</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Elk River</city>
        <state>Minnesota</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Fridley</city>
        <state>Minnesota</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Roseville</city>
        <state>Minnesota</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Saint Francis</city>
        <state>Minnesota</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Longview</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Tyler</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Bountiful</city>
        <state>Utah</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Layton</city>
        <state>Utah</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Syracuse</city>
        <state>Utah</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://trials.boehringer-ingelheim.com/</url>
    <description>Related Info</description>
  </link>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>November 9, 2012</study_first_submitted>
  <study_first_submitted_qc>November 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 14, 2012</study_first_posted>
  <results_first_submitted>March 12, 2020</results_first_submitted>
  <results_first_submitted_qc>March 12, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">March 27, 2020</results_first_posted>
  <disposition_first_submitted>March 25, 2014</disposition_first_submitted>
  <disposition_first_submitted_qc>March 25, 2014</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">April 21, 2014</disposition_first_posted>
  <last_update_submitted>March 12, 2020</last_update_submitted>
  <last_update_submitted_qc>March 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 27, 2020</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>Lower Urinary Tract Symptoms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tamsulosin</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Study had 2 parts: In part 1 participants reviewed the product label and responded to a question about whether the product is appropriate for them to use (self-selection), selected participants then entered part 2 where they recieved study product (actual use).</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>All Subjects</title>
          <description>Part 1 included subjects who answer the self-selection question, probing question and follow-up questions.&#xD;
Part 2 included subjects who self-selected to use the product, purchase the product and took at least one dose of drug and participate in at least 1 phone interview.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Part 1, Self-Selection Phase</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="689"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="679"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Eligibility for Part 2</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="389">No. of subjects potentially eligible for Part 2</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="369"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Eligible but did not enter Part 2</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Part 2, Actual-Use Phase</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="369">20 subjects were eligible for Part 2 but did not enter Part 2</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="330"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other than reason specified above</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Evaluable Analysis Set for Self-Selection (Eval-SS): All subjects who answered self-selection question, probing question and follow-up questions</population>
      <group_list>
        <group group_id="B1">
          <title>All Subjects</title>
          <description>Part 1 included subjects who answer the self-selection question, probing question and follow-up questions.&#xD;
Part 2 included subjects who self-selected to use the product, purchase the product and took at least one dose of drug and participate in at least 1 phone interview.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="679"/>
          </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="65.7" spread="13.2"/>
                  </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="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="679"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Appropriately Followed the Label Instructions</title>
        <description>Includes subjects who reported:&#xD;
No improvement in urinary symptoms and stopped taking product,&#xD;
Reported worsening of urinary symptoms and stopped taking the product,&#xD;
Reported a new urinary symptom and stopped taking the product,&#xD;
Reported no &quot;Stop Use&quot; condition and never took more than 1 capsule on any given day,&#xD;
Reported a &quot;Stop Use&quot; condition and contacted a provider.</description>
        <time_frame>8 weeks</time_frame>
        <population>Full Analysis Set for Actual Use Study (FAS-AUS), all subjects who self-selected to use the product, purchased the product, took at least one dose of the product and participated in at least one phone interview.</population>
        <group_list>
          <group group_id="O1">
            <title>Tamsulosin Hydrochloride</title>
            <description>Participants received tamsulosin hydrochloride 0.4mg capsules, orally, for 8 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Appropriately Followed the Label Instructions</title>
          <description>Includes subjects who reported:&#xD;
No improvement in urinary symptoms and stopped taking product,&#xD;
Reported worsening of urinary symptoms and stopped taking the product,&#xD;
Reported a new urinary symptom and stopped taking the product,&#xD;
Reported no &quot;Stop Use&quot; condition and never took more than 1 capsule on any given day,&#xD;
Reported a &quot;Stop Use&quot; condition and contacted a provider.</description>
          <population>Full Analysis Set for Actual Use Study (FAS-AUS), all subjects who self-selected to use the product, purchased the product, took at least one dose of the product and participated in at least one phone interview.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="321"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Took no More Than One Capsule Per Day</title>
        <description>Percentage of participants who took no more than one capsule per day</description>
        <time_frame>8 weeks</time_frame>
        <population>Subjects who completed all three telephone follow-up interviews out of the FAS population</population>
        <group_list>
          <group group_id="O1">
            <title>Tamsulosin Hydrochloride</title>
            <description>Participants received tamsulosin hydrochloride 0.4mg capsules, orally, for 8 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Took no More Than One Capsule Per Day</title>
          <description>Percentage of participants who took no more than one capsule per day</description>
          <population>Subjects who completed all three telephone follow-up interviews out of the FAS population</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="300"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.7" lower_limit="90.3" upper_limit="96.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of &quot;Use-Days&quot; for All Participants Who Took no More Than One Capsule Per Day</title>
        <description>&quot;Use-day&quot; was defind as a calendar day for which data were available regarding use or non-use.</description>
        <time_frame>8 weeks</time_frame>
        <population>Full Analysis Set for Actual Use Study (FAS-AUS), all subjects who self-selected to use the product, purchased the product, took at least one dose of the product and participated in at least one phone interview</population>
        <group_list>
          <group group_id="O1">
            <title>Tamsulosin Hydrochloride</title>
            <description>Participants received tamsulosin hydrochloride 0.4mg capsules, orally, for 8 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of &quot;Use-Days&quot; for All Participants Who Took no More Than One Capsule Per Day</title>
          <description>&quot;Use-day&quot; was defind as a calendar day for which data were available regarding use or non-use.</description>
          <population>Full Analysis Set for Actual Use Study (FAS-AUS), all subjects who self-selected to use the product, purchased the product, took at least one dose of the product and participated in at least one phone interview</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="321"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.1" lower_limit="90.9" upper_limit="96.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants &lt; 45 Years of Age Who Spoke to a Doctor During the Actual Use Phase</title>
        <description>Includes participants who:&#xD;
were less than 45 years of age at enrollment, and&#xD;
spoke to a doctor during the actual use phase.</description>
        <time_frame>8 weeks</time_frame>
        <population>Full Analysis Set for Actual Use Study- Under 45 years (FAS-AUS45), all subjects less than 45 years of age who self-selected to use the product, purchased the product, took at least one dose of the product and participated in at least one phone interview</population>
        <group_list>
          <group group_id="O1">
            <title>Tamsulosin Hydrochloride</title>
            <description>Participants received tamsulosin hydrochloride 0.4mg capsules, orally, for 8 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants &lt; 45 Years of Age Who Spoke to a Doctor During the Actual Use Phase</title>
          <description>Includes participants who:&#xD;
were less than 45 years of age at enrollment, and&#xD;
spoke to a doctor during the actual use phase.</description>
          <population>Full Analysis Set for Actual Use Study- Under 45 years (FAS-AUS45), all subjects less than 45 years of age who self-selected to use the product, purchased the product, took at least one dose of the product and participated in at least one phone interview</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Are Potentially at Risk of Harm by Incorrectly Selecting to Use the Study Product Out of the Total Study Population</title>
        <description>Percentage of participants who are potentially at risk of harm by incorrectly selecting to use the study product out of the total study population</description>
        <time_frame>8 weeks</time_frame>
        <population>Evaluable Analysis Set for Self-Selection (EVAL-SS), all subjects who answered the self-selection question, probing question and followup questions.</population>
        <group_list>
          <group group_id="O1">
            <title>Tamsulosin Hydrochloride</title>
            <description>Participants received tamsulosin hydrochloride 0.4mg capsules, orally, for 8 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Are Potentially at Risk of Harm by Incorrectly Selecting to Use the Study Product Out of the Total Study Population</title>
          <description>Percentage of participants who are potentially at risk of harm by incorrectly selecting to use the study product out of the total study population</description>
          <population>Evaluable Analysis Set for Self-Selection (EVAL-SS), all subjects who answered the self-selection question, probing question and followup questions.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="679"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.9" lower_limit="17.9" upper_limit="24.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Have a Correct Self-selection Response Out of the Total Study Population</title>
        <description>Percentage of participants who have a correct self-selection response as defined by the &quot;Uses&quot;, &quot;Allergy alert&quot;, and &quot;Do Not Use&quot; sections of the Drug Facts Label.</description>
        <time_frame>8 weeks</time_frame>
        <population>Evaluable Analysis Set for Self-Selection (EVAL-SS), all subjects who answered the self-selection question, probing question and followup questions.</population>
        <group_list>
          <group group_id="O1">
            <title>Tamsulosin Hydrochloride</title>
            <description>Participants received tamsulosin hydrochloride 0.4mg capsules, orally, for 8 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Have a Correct Self-selection Response Out of the Total Study Population</title>
          <description>Percentage of participants who have a correct self-selection response as defined by the &quot;Uses&quot;, &quot;Allergy alert&quot;, and &quot;Do Not Use&quot; sections of the Drug Facts Label.</description>
          <population>Evaluable Analysis Set for Self-Selection (EVAL-SS), all subjects who answered the self-selection question, probing question and followup questions.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="679"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.9" lower_limit="70.5" upper_limit="77.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>8 weeks</time_frame>
      <desc>Treated set</desc>
      <group_list>
        <group group_id="E1">
          <title>EVAL-SS</title>
          <description>Evaluable Analysis Set for Self-Selection (EVAL-SS): The EVAL-SS included all subjects who answered the self-selection question, probing question and follow-up questions (Part 1).</description>
        </group>
        <group group_id="E2">
          <title>Treated Set</title>
          <description>Treated Set (TS): The TS included all subjects who self-selected to use the product, purchased the product, and then took at least one dose of drug (Part 2).</description>
        </group>
        <group group_id="E3">
          <title>FAS-AUS</title>
          <description>Full Analysis Set for Actual Use Decision (FAS-AUS): The FAS-AUS included all subjects who self-selected to use the product, purchased the product, took at least one dose of drug and participated in at least 1 phone interview (Part 2).</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 16.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="679"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="351"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="321"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="679"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="351"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="321"/>
              </event>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="679"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="351"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="321"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="679"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="351"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="321"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="679"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="351"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="321"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="679"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="351"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="321"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="679"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="351"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="321"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="679"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="351"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="321"/>
              </event>
              <event>
                <sub_title>Malignant melanoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="679"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="351"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="321"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="679"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="351"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="321"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="679"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="351"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="321"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 16.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="679"/>
                <counts group_id="E2" subjects_affected="26" subjects_at_risk="351"/>
                <counts group_id="E3" subjects_affected="22" subjects_at_risk="321"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="679"/>
                <counts group_id="E2" subjects_affected="26" subjects_at_risk="351"/>
                <counts group_id="E3" subjects_affected="22" subjects_at_risk="321"/>
              </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>1-800-243-0127</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/NCT01726270
org study id: 527.82
nct id: NCT01726270
lead sponsor: 
Multicenter trial conducted in Pharmacy retail centers
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants Who Appropriately Followed the Label Instructions
time frame: 8 weeks
description: Includes subjects who reported:
No improvement in urinary symptoms and stopped taking product,
Reported worsening of urinary symptoms and stopped taking the product,
Reported a new urinary symptom and stopped taking the product,
Reported no "Stop Use" condition and never took more than 1 capsule on any given day,
Reported a "Stop Use" condition and contacted a provider.
measure: Percentage of Participants Who Took no More Than One Capsule Per Day
time frame: 8 weeks
description: Percentage of participants who took no more than one capsule per day
measure: Percentage of "Use-Days" for All Participants Who Took no More Than One Capsule Per Day
time frame: 8 weeks
description: "Use-day" was defind as a calendar day for which data were available regarding use or non-use.
measure: Percentage of Participants < 45 Years of Age Who Spoke to a Doctor During the Actual Use Phase
time frame: 8 weeks
description: Includes participants who:
were less than 45 years of age at enrollment, and
spoke to a doctor during the actual use phase.
measure: Percentage of Participants Who Are Potentially at Risk of Harm by Incorrectly Selecting to Use the Study Product Out of the Total Study Population
time frame: 8 weeks
description: Percentage of participants who are potentially at risk of harm by incorrectly selecting to use the study product out of the total study population
measure: Percentage of Participants Who Have a Correct Self-selection Response Out of the Total Study Population
time frame: 8 weeks
description: Percentage of participants who have a correct self-selection response as defined by the "Uses", "Allergy alert", and "Do Not Use" sections of the Drug Facts Label.
arm group label: tamsulosin hydrochloride
arm group type: Experimental
description: patients will take drug for 8 weeks in this exploratory study
intervention type: Drug
intervention name: tamsulosin
description: 0.4 mg
arm group label: tamsulosin hydrochloride
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Boehringer Ingelheim
role: Study Chair
affiliation: Boehringer Ingelheim
facility: 
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country: United States
url: http://trials.boehringer-ingelheim.com/
description: Related Info
responsible party type: Sponsor
mesh term: Lower Urinary Tract Symptoms
mesh term: Tamsulosin
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 