<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/NCT01716052</url>
  </required_header>
  <id_info>
    <org_study_id>CTRC 11-45</org_study_id>
    <secondary_id>HSC20120142H</secondary_id>
    <nct_id>NCT01716052</nct_id>
  </id_info>
  <brief_title>Women's Mammography Study To Improve Comfort During Mammography</brief_title>
  <official_title>Women's Mammography Study Attempting to Improve the Comfort During Screening Mammography CTRC#11-45</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kenneth A. Kist,</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Texas Health Science Center at San Antonio</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine in a randomized trial whether it is possible to&#xD;
      decrease the discomfort of mammography by using the analgesic ibuprofen, or by using a&#xD;
      scripted, supportive text informing patients about mammography.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is designed to evaluate two methods of reducing pain and discomfort caused by&#xD;
      mammography, one of the barriers to the procedure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Lack of funding.&#xD;
  </why_stopped>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">June 2013</primary_completion_date>
  <phase>N/A</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>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Measure of Discomfort of Mammography</measure>
    <time_frame>3 years</time_frame>
    <description>The primary outcome measure will be the response to questions on a questionnaire.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Ibuprofen</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Pfizer 200 mg caplets (Advil)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Lactulose</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>Lactulose</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ibuprofen</intervention_name>
    <arm_group_label>Ibuprofen</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must have signed the informed consent.&#xD;
&#xD;
          -  Must either be getting her first mammogram or based on prior experience be expecting&#xD;
             level 4 or 5 pain&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  May not have taken ibuprofen or other pain medication within the last 12 hours.&#xD;
&#xD;
          -  Must not have a contraindication for taking ibuprofen e.g:&#xD;
&#xD;
          -  No history of allergic reactions to ibuprofen or aspirin&#xD;
&#xD;
          -  No recent history with the last year of bleeding from GI tract&#xD;
&#xD;
          -  Not pregnant or suspected of being pregnant&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kenneth Kist, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Texas</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cancer Therapy and Research Center at UTHSCSA</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>October 18, 2012</study_first_submitted>
  <study_first_submitted_qc>October 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 29, 2012</study_first_posted>
  <results_first_submitted>January 13, 2015</results_first_submitted>
  <results_first_submitted_qc>January 13, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">January 19, 2015</results_first_posted>
  <last_update_submitted>December 1, 2015</last_update_submitted>
  <last_update_submitted_qc>December 1, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 30, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>The University of Texas Health Science Center at San Antonio</investigator_affiliation>
    <investigator_full_name>Kenneth A. Kist,</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Mammogram</keyword>
  <keyword>Ibuprofen</keyword>
  <keyword>Pain management</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ibuprofen</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>When the woman signs in at the breast imaging clinic desk (on the 5th floor of the Zeller Building at the CTRC), she will be asked if she would speak with the study nurse about this study.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Ibuprofen</title>
          <description>Pfizer 200 mg caplets (Advil)&#xD;
Ibuprofen</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Lactulose&#xD;
placebo: Lactulose</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal of funding</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Two sided significance level of 0.05 and a statistical power of 0.90 with 187 patients in both the placebo and the ibuprofen group..</population>
      <group_list>
        <group group_id="B1">
          <title>Ibuprofen</title>
          <description>Pfizer 200 mg caplets (Advil)&#xD;
Ibuprofen</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Lactulose&#xD;
placebo: Lactulose</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="1"/>
            <count group_id="B2" value="1"/>
            <count group_id="B3" value="2"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Measure of Discomfort of Mammography</title>
        <description>The primary outcome measure will be the response to questions on a questionnaire.</description>
        <time_frame>3 years</time_frame>
        <population>No data was collected or analyzed for the outcome measure because the study was terminated.</population>
        <group_list>
          <group group_id="O1">
            <title>Ibuprofen</title>
            <description>Pfizer 200 mg caplets (Advil)&#xD;
Ibuprofen</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Lactulose&#xD;
placebo: Lactulose</description>
          </group>
        </group_list>
        <measure>
          <title>Measure of Discomfort of Mammography</title>
          <description>The primary outcome measure will be the response to questions on a questionnaire.</description>
          <population>No data was collected or analyzed for the outcome measure because the study was terminated.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>Total number of participants at risk is &quot;0&quot; since adverse events were not collected/assessed.</desc>
      <group_list>
        <group group_id="E1">
          <title>Ibuprofen</title>
          <description>Pfizer 200 mg caplets (Advil)&#xD;
Ibuprofen</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Lactulose&#xD;
placebo: Lactulose</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="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</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="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Kenneth Kist</name_or_title>
      <organization>UTHSCSA @CTRC</organization>
      <phone>210-450-5600</phone>
      <email>KIST@UTHSCSA.EDU</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/NCT01716052
org study id: CTRC 11-45
secondary id: HSC20120142H
nct id: NCT01716052
lead sponsor: 
has dmc: No
The purpose of this study is to determine in a randomized trial whether it is possible to
      decrease the discomfort of mammography by using the analgesic ibuprofen, or by using a
      scripted, supportive text informing patients about mammography.
This study is designed to evaluate two methods of reducing pain and discomfort caused by
      mammography, one of the barriers to the procedure.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Measure of Discomfort of Mammography
time frame: 3 years
description: The primary outcome measure will be the response to questions on a questionnaire.
arm group label: Ibuprofen
arm group type: Active Comparator
description: Pfizer 200 mg caplets (Advil)
arm group label: Placebo
arm group type: Placebo Comparator
description: Lactulose
intervention type: Drug
intervention name: placebo
description: Lactulose
arm group label: Placebo
intervention type: Drug
intervention name: Ibuprofen
arm group label: Ibuprofen
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kenneth Kist, MD
role: Principal Investigator
affiliation: University of Texas
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: The University of Texas Health Science Center at San Antonio
investigator full name: Kenneth A. Kist,
investigator title: Principal Investigator
mesh term: Ibuprofen
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 