<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/NCT01675050</url>
  </required_header>
  <id_info>
    <org_study_id>HUM00056045</org_study_id>
    <nct_id>NCT01675050</nct_id>
  </id_info>
  <brief_title>A Placebo-controlled Crossover Trial Using Cyproheptadine To Treat Children With Functional Abdominal Pain</brief_title>
  <official_title>A Placebo-controlled Crossover Trial Using Cyproheptadine To Treat Children With Functional Abdominal Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Michigan</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators hypothesize that using Cyproheptadine in a placebo-controlled crossover&#xD;
      trial would help relieve abdominal pain associated with (Functional Abdominal Pain (FAP) in&#xD;
      children, achieving a greater response than that observed with placebo. In addition to&#xD;
      assessing self-report of pain and other symptoms, the investigators also propose to perform&#xD;
      experimental somatic pain testing to determine if there is evidence of&#xD;
      peripherally-maintained central sensitization in children with FAP. The investigators also&#xD;
      hypothesize that there will be an increase in somatic pain threshold after completion of a&#xD;
      Cyproheptadine course compared to baseline testing prior to treatment, and compared to&#xD;
      placebo. This would allow children with FAP to return to normal function, improve symptoms&#xD;
      and overall general well-being&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Due to the wide availability of the drug in clinical practice, it was impossible to recruit&#xD;
    adequate numbers for scientific power.&#xD;
  </why_stopped>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">August 2013</completion_date>
  <primary_completion_date type="Actual">August 2013</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pressure Pain Threshold</measure>
    <time_frame>at 4 weeks of cyproheptadine or placebo treatment</time_frame>
    <description>Increasing pressures were applied with a pressure plunger to the participants' thumbnail. The pressure at which the participant said that s/he felt pain is noted. The pressure is measured in kilograms by centimeters squared.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Abdominal Pain</measure>
    <time_frame>10 weeks</time_frame>
    <description>Participants rated the highest intensity of abdominal pain they experienced during the past two weeks on a scale of 0 (No Pain) to 10 (The Most Pain Possible), as derived from the &quot;Abdominal Pain Index - Child Version&quot; (Laird et al. 2015. Journal of Pediatric Psychology, 40(5), 517-525).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Functional Abdominal Pain</condition>
  <arm_group>
    <arm_group_label>Cyproheptadine first then Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>4 weeks of cyproheptadine or placebo with crossover to the other</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sugar Pill first then Cyprotheptadine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>4 weeks of cyproheptadine or placebo with crossover to the other</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cyproheptadine</intervention_name>
    <description>4 weeks of cyproheptadine or placebo with crossover to the other</description>
    <arm_group_label>Cyproheptadine first then Placebo</arm_group_label>
    <arm_group_label>Sugar Pill first then Cyprotheptadine</arm_group_label>
    <other_name>Periactin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>sugar pill</intervention_name>
    <description>4 weeks of cyproheptadine or placebo with crossover to the other</description>
    <arm_group_label>Cyproheptadine first then Placebo</arm_group_label>
    <arm_group_label>Sugar Pill first then Cyprotheptadine</arm_group_label>
    <other_name>placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 8 and 18 years-old&#xD;
&#xD;
          -  Diagnosed with Functional Abdominal Pain using the Rome III Criteria must include all*&#xD;
             of the following:&#xD;
&#xD;
               1. Episodic or continuous abdominal pain&#xD;
&#xD;
               2. Insufficient criteria for other FGIDs&#xD;
&#xD;
               3. No evidence of an inflammatory, anatomic, metabolic, or neoplastic process that&#xD;
                  explains the subject's symptoms&#xD;
&#xD;
                    -  Criteria fulfilled at least once per week for at least 2 months prior to&#xD;
                       diagnosis&#xD;
&#xD;
          -  Written informed consent obtained from the patient/guardian before the initiation of&#xD;
             any study-specific procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 8 years-old or Age &gt;18 years-old&#xD;
&#xD;
          -  Child or parent are non-English speakers&#xD;
&#xD;
          -  Child is using other CNS depressants (cyproheptadine causes drowsiness, and may&#xD;
             enhance the adverse/toxic effect of other CNS Depressants e.g. opioids, barbiturates,&#xD;
             Droperidol, Hydroxyzine, Alcohol)(29)&#xD;
&#xD;
          -  Child has a history of hypersensitivity to Cyproheptadine products&#xD;
&#xD;
          -  Child is currently using monoamine oxidase inhibitor (MAOI e.g. Nardil, Marplan,&#xD;
             Parnate) (can cause a prolonged or intensified anticholinergic effect)&#xD;
&#xD;
          -  Child was treated with Cyproheptadine in the past 4 weeks&#xD;
&#xD;
          -  Child is currently using anticholinergic (can cause an additive anticholinergic effect&#xD;
             e.g. Pramlintide)&#xD;
&#xD;
          -  Concomitant SSRI use ( being a serotonin antagonist, may oppose effects)&#xD;
&#xD;
          -  Concomitant use of Betahistine: Antihistamines may diminish the therapeutic effect of&#xD;
             Betahistine&#xD;
&#xD;
          -  Concomitant use of Acetylcholinesterase Inhibitors (Central): Anticholinergics may&#xD;
             diminish the therapeutic effect of Acetylcholinesterase Inhibitors (Central) and vice&#xD;
             versa.&#xD;
&#xD;
          -  Child has a personal history of glaucoma&#xD;
&#xD;
          -  Child has asthma (can cause thickening of bronchial secretions) (27,28)&#xD;
&#xD;
          -  History of liver dysfunction/disease (can cause hepatitis)&#xD;
&#xD;
          -  History of cardiac disease (not specific to Cyproheptadine, antihistamines have been&#xD;
             associated with hypotension, palpitations, tachycardia and arrhythmias) (28,29).&#xD;
&#xD;
          -  Females who are known to be pregnant will also be excluded. All females who are of&#xD;
             child bearing age, or are already menstruating will perform a urine pregnancy test&#xD;
             before enrolling.&#xD;
&#xD;
          -  Any children who have difficulties swallowing tablets will receive teaching on how to&#xD;
             swallow tablets. If they are still unable to do so, they will not participate in the&#xD;
             study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ismaeel Hashemi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UmichiganHS</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 27, 2012</study_first_submitted>
  <study_first_submitted_qc>August 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2012</study_first_posted>
  <results_first_submitted>May 26, 2017</results_first_submitted>
  <results_first_submitted_qc>May 26, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">June 21, 2017</results_first_posted>
  <last_update_submitted>August 1, 2017</last_update_submitted>
  <last_update_submitted_qc>August 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Ismaeel Hashemi</investigator_full_name>
    <investigator_title>Fellow Physician</investigator_title>
  </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>Cyproheptadine</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Cyproheptadine First, Then Placebo</title>
          <description>4 weeks of cyproheptadine with crossover to 4 weeks of placebo.</description>
        </group>
        <group group_id="P2">
          <title>Sugar Pill First, Than Cyproheptadine</title>
          <description>4 weeks of placebo (sugar pill) with crossover to 4 weeks of cyproheptadine</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Period One Treatment</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Wash Out Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Second Period Treatment</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Cyproheptadine Then Placebo</title>
          <description>4 weeks of cyproheptadine with crossover to 4 weeks of placebo.</description>
        </group>
        <group group_id="B2">
          <title>Placebo Then Cyproheptadine</title>
          <description>4 weeks of placebo (sugar pill) with crossover to 4 weeks of cyproheptadine</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="2"/>
            <count group_id="B2" value="2"/>
            <count group_id="B3" value="4"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2"/>
                    <count group_id="B2" value="2"/>
                    <count group_id="B3" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12.5" lower_limit="9" upper_limit="16"/>
                    <measurement group_id="B2" value="10.5" lower_limit="9" upper_limit="12"/>
                    <measurement group_id="B3" value="11.5" lower_limit="9" upper_limit="16"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2"/>
                    <count group_id="B2" value="2"/>
                    <count group_id="B3" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2"/>
                    <count group_id="B2" value="2"/>
                    <count group_id="B3" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Pressure Pain Threshold</title>
          <description>Increasing pressures are applied with a pressure plunger to the participants' thumbnail. The pressure at which the participant said that s/he felt pain is noted. The pressure is measured in in kilograms divided by centimeters squared.</description>
          <population>Because 1 participant on the Cyproheptadine first side dropped out prior to assignment to placebo, there is only 1 participant shown on the cyproheptadine first then placebo side for the second baseline after washout prior to placebo.</population>
          <units>kg/cm^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Baseline prior to First Treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2"/>
                    <count group_id="B2" value="2"/>
                    <count group_id="B3" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.75" spread="2"/>
                    <measurement group_id="B2" value="1.28" spread=".53"/>
                    <measurement group_id="B3" value="1.51" spread=".99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline prior to Second Treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="1"/>
                    <count group_id="B2" value="2"/>
                    <count group_id="B3" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.25" spread="0"/>
                    <measurement group_id="B2" value="1.08" spread=".18"/>
                    <measurement group_id="B3" value="1.13" spread=".16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Improvement in Abdominal Pain</title>
          <description>This is a pain scale derived from the abdominal pain Index child version, where on a scale of zero to 10, zero represents no pain, and ten represents the most pain possible</description>
          <population>Because 1 participant in the Cyproheptadine first group withdrew prior to washout, that participant's data is not included in the pre-placebo period baseline.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Baseline prior to First Treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="2"/>
                    <count group_id="B2" value="2"/>
                    <count group_id="B3" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4" spread="5.66"/>
                    <measurement group_id="B2" value="8.5" spread="2.12"/>
                    <measurement group_id="B3" value="6.25" spread="4.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline prior to Second Treatment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="1"/>
                    <count group_id="B2" value="2"/>
                    <count group_id="B3" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6" spread="0"/>
                    <measurement group_id="B2" value="6.5" spread="3.45"/>
                    <measurement group_id="B3" value="6.33" spread="2.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Pressure Pain Threshold</title>
        <description>Increasing pressures were applied with a pressure plunger to the participants' thumbnail. The pressure at which the participant said that s/he felt pain is noted. The pressure is measured in kilograms by centimeters squared.</description>
        <time_frame>at 4 weeks of cyproheptadine or placebo treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>All Participants Post Cyproheptadine</title>
          </group>
          <group group_id="O2">
            <title>All Participants Post Placebo</title>
          </group>
        </group_list>
        <measure>
          <title>Pressure Pain Threshold</title>
          <description>Increasing pressures were applied with a pressure plunger to the participants' thumbnail. The pressure at which the participant said that s/he felt pain is noted. The pressure is measured in kilograms by centimeters squared.</description>
          <units>kg/cm^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.15" spread=".73"/>
                    <measurement group_id="O2" value="1.23" spread=".39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Abdominal Pain</title>
        <description>Participants rated the highest intensity of abdominal pain they experienced during the past two weeks on a scale of 0 (No Pain) to 10 (The Most Pain Possible), as derived from the &quot;Abdominal Pain Index - Child Version&quot; (Laird et al. 2015. Journal of Pediatric Psychology, 40(5), 517-525).</description>
        <time_frame>10 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>All Participants Post Cyproheptadine</title>
          </group>
          <group group_id="O2">
            <title>All Participants Post Placebo</title>
          </group>
        </group_list>
        <measure>
          <title>Abdominal Pain</title>
          <description>Participants rated the highest intensity of abdominal pain they experienced during the past two weeks on a scale of 0 (No Pain) to 10 (The Most Pain Possible), as derived from the &quot;Abdominal Pain Index - Child Version&quot; (Laird et al. 2015. Journal of Pediatric Psychology, 40(5), 517-525).</description>
          <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="4"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.25" spread="4.11"/>
                    <measurement group_id="O2" value="8" spread="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>10 weeks during study</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Cyproheptadine</title>
          <description>All participants while on Cyproheptadine.</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>All participants while on Placebo.</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="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Non-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="3" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Increase Appetite</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Weakness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Somnolence (Drowsiness)</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Restless Sleeping Pattern</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Trouble Sleeping (Insomnia)</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Cold Sweats</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="3"/>
              </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>
    <limitations_and_caveats>Statistical analyses were not conducted due to small sample size. Results should be interpreted with extreme caution.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Ismaeel Hashemi, M.D. Principal Investigator</name_or_title>
      <organization>University of Michigan</organization>
      <phone>6169165566</phone>
      <email>ismaeel.hashemi@gmail.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/NCT01675050
org study id: HUM00056045
nct id: NCT01675050
lead sponsor: 
has dmc: Yes
The investigators hypothesize that using Cyproheptadine in a placebo-controlled crossover
      trial would help relieve abdominal pain associated with (Functional Abdominal Pain (FAP) in
      children, achieving a greater response than that observed with placebo. In addition to
      assessing self-report of pain and other symptoms, the investigators also propose to perform
      experimental somatic pain testing to determine if there is evidence of
      peripherally-maintained central sensitization in children with FAP. The investigators also
      hypothesize that there will be an increase in somatic pain threshold after completion of a
      Cyproheptadine course compared to baseline testing prior to treatment, and compared to
      placebo. This would allow children with FAP to return to normal function, improve symptoms
      and overall general well-being
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Pressure Pain Threshold
time frame: at 4 weeks of cyproheptadine or placebo treatment
description: Increasing pressures were applied with a pressure plunger to the participants' thumbnail. The pressure at which the participant said that s/he felt pain is noted. The pressure is measured in kilograms by centimeters squared.
measure: Abdominal Pain
time frame: 10 weeks
description: Participants rated the highest intensity of abdominal pain they experienced during the past two weeks on a scale of 0 (No Pain) to 10 (The Most Pain Possible), as derived from the "Abdominal Pain Index - Child Version" (Laird et al. 2015. Journal of Pediatric Psychology, 40(5), 517-525).
arm group label: Cyproheptadine first then Placebo
arm group type: Experimental
description: 4 weeks of cyproheptadine or placebo with crossover to the other
arm group label: Sugar Pill first then Cyprotheptadine
arm group type: Experimental
description: 4 weeks of cyproheptadine or placebo with crossover to the other
intervention type: Drug
intervention name: Cyproheptadine
description: 4 weeks of cyproheptadine or placebo with crossover to the other
arm group label: Cyproheptadine first then Placebo
arm group label: Sugar Pill first then Cyprotheptadine
other name: Periactin
intervention type: Drug
intervention name: sugar pill
description: 4 weeks of cyproheptadine or placebo with crossover to the other
arm group label: Cyproheptadine first then Placebo
arm group label: Sugar Pill first then Cyprotheptadine
other name: placebo
criteria: 
gender: All
minimum age: 8 Years
maximum age: 18 Years
healthy volunteers: No
last name: Ismaeel Hashemi, MD
role: Principal Investigator
affiliation: University of Michigan
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Ismaeel Hashemi
investigator title: Fellow Physician
mesh term: Abdominal Pain
mesh term: Cyproheptadine
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Statistical analyses were not conducted due to small sample size. Results should be interpreted with extreme caution.
point of contact: 