<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/NCT01678911</url>
  </required_header>
  <id_info>
    <org_study_id>RIC_Dep_CPP_2012</org_study_id>
    <nct_id>NCT01678911</nct_id>
  </id_info>
  <brief_title>Efficacy of Gralise® for Chronic Pelvic Pain</brief_title>
  <official_title>Efficacy of Gralise® for Chronic Pelvic Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shirley Ryan AbilityLab</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shirley Ryan AbilityLab</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is done to investigate the pain relieving effects of the study drug Gralise (a&#xD;
      novel long acting gabapentinoid) for people who experience chronic pelvic pain. Subjects with&#xD;
      Irritable Bowel Syndrome, Interstitial Cystitis, Ulcerative Colitis, and Prostatitis will be&#xD;
      recruited. The purpose of this research is to look at how the study drug can be used to&#xD;
      benefit people who experience this type of pain. This is a phase IV study done to study the&#xD;
      safety and effectiveness of the drug. At this point the drug has been approved by the Food&#xD;
      and Drug Administration and has been reported to be well tolerated and effective in the&#xD;
      treatment of various chronic pain conditions, particularly in neuropathic pain. About 36&#xD;
      subjects will take part in this study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      As a participant in this study, you will be asked to come to the Rehabilitation Institute of&#xD;
      Chicago (RIC), Center for Pain Studies (446 E Ontario St. Suite 1011, Chicago, IL 60611).&#xD;
      Your part in this study will last for 15 weeks and will involve 4 visits to the&#xD;
      Rehabilitation Institute of Chicago and anywhere from weekly phone calls to phone calls every&#xD;
      other day.&#xD;
&#xD;
      If you are in this study, you will be placed in one of two study groups: one group will&#xD;
      receive the study drug followed by a placebo and the second group will receive a placebo&#xD;
      followed by the study drug. The amount of weeks on placebo versus the study drug will not be&#xD;
      equal. You will be assigned a study group by chance using a process similar to the flip of a&#xD;
      coin. This process is called randomization. Neither you nor the study staff will select the&#xD;
      group you will be in. However, if you have a medical emergency, we can get this information.&#xD;
      A placebo looks like the study drug but is an inactive substance that has no medication.&#xD;
      Researchers use a placebo to see if the study drug works better or is safer than not taking&#xD;
      anything.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Study ended due to difficulties in recruitment and low enrollment.&#xD;
  </why_stopped>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">March 2014</primary_completion_date>
  <phase>Phase 4</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>McGill Pain Questionnaire - Short Form</measure>
    <time_frame>4 Visits over a 15 week period</time_frame>
    <description>The MPQ-SF is a well-validated pain measure that permits separation of the sensory and affective components of pain, which are averaged to compute a total score. The scale ranges from 0-10 (0=no pain, 10=the most pain).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain Anxiety Symptoms Scale</measure>
    <time_frame>4 Visits over an 8 week period</time_frame>
    <description>The Pain Anxiety Symptoms Scale (PASS) is an anxiety scale from 0 - 100, where 0 = no anxiety and 100 = the most anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Disability Index</measure>
    <time_frame>4 visits over an 8 week period</time_frame>
    <description>The PDI is a seven-item, validated instrument that assesses perceived disability in seven key life areas. It provides a total disability score, and is an indirect measure of self efficacy. The Pain Disability Scale is a scale from 0 - 70, where 0 = no Disability and 70 = the most Disability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Center for Epidemiologic Studies Depression Scale</measure>
    <time_frame>4 visits over 15 week period</time_frame>
    <description>The CES-D 10 is a 10-item questionnaire that has been validated for the assessment of depressive symptomatology. The Depression Scale is a scale with a sum score from 0 - 30, where 0 = no Depression and 30 = the most Depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Global Impression of Change</measure>
    <time_frame>4 Visits over 15 weeks</time_frame>
    <description>Patient Global Impression of Change is a self-report questionnaire on which patient indicate their perceived impression of change since the start of the study given the following options: Very Much Improved, Much Improved, Minimally Improved, No Change, Minimally Worse, Much Worse, or Very much Worse.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Irritable Bowel Syndrome</condition>
  <condition>Ulcerative Colitis</condition>
  <condition>Interstitial Cystitis</condition>
  <condition>Prostatitis</condition>
  <condition>Pelvic Pain</condition>
  <arm_group>
    <arm_group_label>Placebo then Gralise</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects may receive a pill with no medicine (placebo) for phase 1. Subject washout, then cross over to Gralise in Phase 2.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gralise then Placebo</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects recieve Gralise (a long acting gabapentinoid) for phase 1.Subject washout, then cross over to placebo in Phase 2.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gralise</intervention_name>
    <description>Subjects will start at 600mg and titrate up by 600mg a week for two weeks (to 1800mg), then remain on 1800mg steady state dose of medication (or placebo pills) for 2 weeks. If intolerable side effects occur, the dose may be reduced to last tolerable dose at the discretion of the PI. A 2-week down-titration will be used. Subjects will have 1 week of &quot;wash-out&quot; before repeating the above procedure for the other arm of the study (placebo or medication).</description>
    <arm_group_label>Gralise then Placebo</arm_group_label>
    <arm_group_label>Placebo then Gralise</arm_group_label>
    <other_name>Gabapentin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age and older&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  able to give consent&#xD;
&#xD;
          -  willing to use electronic diary during entire length of the study&#xD;
&#xD;
          -  has 'chronic' pelvic pain&#xD;
&#xD;
          -  Meets one of the following diagnostic criteria for one of the following: Irritable&#xD;
             Bowel Syndrome (IBS) Ulcerative Colitis (UC), Interstitial Cystitis (IC), and&#xD;
             Prostatitis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  allergic to gabapentin or inactive ingredients&#xD;
&#xD;
          -  taking gabapentinoids (i.e. gabapentin or pre-gabalin)&#xD;
&#xD;
          -  with severe or unmanaged psychiatric disturbance (at PI discretion)&#xD;
&#xD;
          -  with severe ongoing or unaddressed medical conditions (esp. Renal or Hepatic disease,&#xD;
             uncontrolled hypertension), rheumatologic disease, narrow angle glaucoma,&#xD;
             hyponatremia, clotting disorders, uncontrolled seizure disorder or urinary retention.&#xD;
&#xD;
          -  who plan to change their therapeutic regimen during the course of the trial (e.g.&#xD;
             start physical therapy, massage, medications, injections, etc.)&#xD;
&#xD;
          -  with acute pain&#xD;
&#xD;
        Female subjects:&#xD;
&#xD;
          -  pregnant or plan to become pregnant&#xD;
&#xD;
          -  gave birth within the last 6 months&#xD;
&#xD;
          -  breastfeeding&#xD;
&#xD;
          -  episodic visceral pain (e.g. endometriosis)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Norman Harden, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shirley Ryan AbilityLab</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rehabilitation Institute Of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>August 31, 2012</study_first_submitted>
  <study_first_submitted_qc>August 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2012</study_first_posted>
  <results_first_submitted>May 20, 2015</results_first_submitted>
  <results_first_submitted_qc>June 26, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">June 29, 2015</results_first_posted>
  <last_update_submitted>June 26, 2015</last_update_submitted>
  <last_update_submitted_qc>June 26, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 29, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shirley Ryan AbilityLab</investigator_affiliation>
    <investigator_full_name>Dr. Norman Harden</investigator_full_name>
    <investigator_title>Director, Center for Pain Studies</investigator_title>
  </responsible_party>
  <keyword>Pelvic Pain</keyword>
  <keyword>Chronic Pelvic Pain</keyword>
  <keyword>Irritable Bowel Syndrome</keyword>
  <keyword>IBS</keyword>
  <keyword>Ulcerative Colitis</keyword>
  <keyword>UC</keyword>
  <keyword>Interstitial Cystitis</keyword>
  <keyword>IC</keyword>
  <keyword>Prostatitis</keyword>
  <keyword>Pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colitis</mesh_term>
    <mesh_term>Colitis, Ulcerative</mesh_term>
    <mesh_term>Irritable Bowel Syndrome</mesh_term>
    <mesh_term>Cystitis</mesh_term>
    <mesh_term>Cystitis, Interstitial</mesh_term>
    <mesh_term>Prostatitis</mesh_term>
    <mesh_term>Pelvic Pain</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gabapentin</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>11 Subjects enrolled in the study and started a single-blind placebo lead-in period. Of those, 5 were randomized. 6 subjects did not continue and were either lost to follow-up, chose not to continue, or exhibited a large placebo response and no longer met the criteria to continue in the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo, Then Gralise</title>
          <description>Subjects may receive a pill with no medicine.</description>
        </group>
        <group group_id="P2">
          <title>Gralise Then Placebo</title>
          <description>Gralise (a long acting gabapentinoid)&#xD;
Gralise: Subjects will start at 600mg and titrate up by 600mg a week for two weeks (to 1800mg), then remain on 1800mg steady state dose of medication (or placebo pills) for 2 weeks. If intolerable side effects occur, the dose may be reduced to last tolerable dose at the discretion of the PI. A 2-week down-titration will be used. Subjects will have 1 week of &quot;wash-out&quot; before repeating the above procedure for the other arm of the study (placebo or medication).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>First Intervention</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Cross Over</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="1"/>
              </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 Intervention</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>All Subjects</title>
          <description>All randomized subjects</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="5"/>
          </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="44.6" 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="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>McGill Pain Questionnaire - Short Form</title>
        <description>The MPQ-SF is a well-validated pain measure that permits separation of the sensory and affective components of pain, which are averaged to compute a total score. The scale ranges from 0-10 (0=no pain, 10=the most pain).</description>
        <time_frame>4 Visits over a 15 week period</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo Then Gralise</title>
            <description>Subjects may receive a pill with no medicine (placebo) for phase 1. Subject washout, then cross over to Gralise in Phase 2.</description>
          </group>
          <group group_id="O2">
            <title>Gralise Then Placebo</title>
            <description>Subjects recieve Gralise (a long acting gabapentinoid) for phase 1.Subject washout, then cross over to placebo in Phase 2.</description>
          </group>
        </group_list>
        <measure>
          <title>McGill Pain Questionnaire - Short Form</title>
          <description>The MPQ-SF is a well-validated pain measure that permits separation of the sensory and affective components of pain, which are averaged to compute a total score. The scale ranges from 0-10 (0=no pain, 10=the most pain).</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="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>change from baseline after intervention 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.34" spread="1.78"/>
                    <measurement group_id="O2" value=".04" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>change from baseline after intervention 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.05" spread="0.45"/>
                    <measurement group_id="O2" value=".41" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Anxiety Symptoms Scale</title>
        <description>The Pain Anxiety Symptoms Scale (PASS) is an anxiety scale from 0 - 100, where 0 = no anxiety and 100 = the most anxiety.</description>
        <time_frame>4 Visits over an 8 week period</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo Then Gralise</title>
            <description>Subjects may receive a pill with no medicine (placebo) for phase 1. Subject washout, then cross over to Gralise in Phase 2.</description>
          </group>
          <group group_id="O2">
            <title>Gralise Then Placebo</title>
            <description>Subjects recieve Gralise (a long acting gabapentinoid) for phase 1.Subject washout, then cross over to placebo in Phase 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Anxiety Symptoms Scale</title>
          <description>The Pain Anxiety Symptoms Scale (PASS) is an anxiety scale from 0 - 100, where 0 = no anxiety and 100 = the most anxiety.</description>
          <units>units on the PASS 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="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>mean change after intervention 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.8" spread="18.0"/>
                    <measurement group_id="O2" value="-4" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>mean change after intervention 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.0" spread="22.6"/>
                    <measurement group_id="O2" value="-5" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Disability Index</title>
        <description>The PDI is a seven-item, validated instrument that assesses perceived disability in seven key life areas. It provides a total disability score, and is an indirect measure of self efficacy. The Pain Disability Scale is a scale from 0 - 70, where 0 = no Disability and 70 = the most Disability.</description>
        <time_frame>4 visits over an 8 week period</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo Then Gralise</title>
            <description>Subjects may receive a pill with no medicine (placebo) for phase 1. Subject washout, then cross over to Gralise in Phase 2.</description>
          </group>
          <group group_id="O2">
            <title>Gralise Then Placebo</title>
            <description>Subjects recieve Gralise (a long acting gabapentinoid) for phase 1.Subject washout, then cross over to placebo in Phase 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Disability Index</title>
          <description>The PDI is a seven-item, validated instrument that assesses perceived disability in seven key life areas. It provides a total disability score, and is an indirect measure of self efficacy. The Pain Disability Scale is a scale from 0 - 70, where 0 = no Disability and 70 = the most Disability.</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="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>change after intervention 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.8" spread="13.9"/>
                    <measurement group_id="O2" value="10" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>change after intervention 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19" spread="4.2"/>
                    <measurement group_id="O2" value="14" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Center for Epidemiologic Studies Depression Scale</title>
        <description>The CES-D 10 is a 10-item questionnaire that has been validated for the assessment of depressive symptomatology. The Depression Scale is a scale with a sum score from 0 - 30, where 0 = no Depression and 30 = the most Depression.</description>
        <time_frame>4 visits over 15 week period</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo Then Gralise</title>
            <description>Subjects may receive a pill with no medicine (placebo) for phase 1. Subject washout, then cross over to Gralise in Phase 2.</description>
          </group>
          <group group_id="O2">
            <title>Gralise Then Placebo</title>
            <description>Subjects recieve Gralise (a long acting gabapentinoid) for phase 1.Subject washout, then cross over to placebo in Phase 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Center for Epidemiologic Studies Depression Scale</title>
          <description>The CES-D 10 is a 10-item questionnaire that has been validated for the assessment of depressive symptomatology. The Depression Scale is a scale with a sum score from 0 - 30, where 0 = no Depression and 30 = the most Depression.</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="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>change after intervention 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5" spread="5.7"/>
                    <measurement group_id="O2" value="-1" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>change after intervention 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7" spread="2.8"/>
                    <measurement group_id="O2" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Global Impression of Change</title>
        <description>Patient Global Impression of Change is a self-report questionnaire on which patient indicate their perceived impression of change since the start of the study given the following options: Very Much Improved, Much Improved, Minimally Improved, No Change, Minimally Worse, Much Worse, or Very much Worse.</description>
        <time_frame>4 Visits over 15 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Placebo Then Gralise</title>
            <description>Subjects may receive a pill with no medicine (placebo) for phase 1. Subject washout, then cross over to Gralise in Phase 2.</description>
          </group>
          <group group_id="O2">
            <title>Gralise Then Placebo</title>
            <description>Subjects recieve Gralise (a long acting gabapentinoid) for phase 1.Subject washout, then cross over to placebo in Phase 2.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Global Impression of Change</title>
          <description>Patient Global Impression of Change is a self-report questionnaire on which patient indicate their perceived impression of change since the start of the study given the following options: Very Much Improved, Much Improved, Minimally Improved, No Change, Minimally Worse, Much Worse, or Very much Worse.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>improved after intervention 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>no change after intervention 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>worse after intervention 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>improved after intervention 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>no change after intervention 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>worse after intervention 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Sugar Pill</title>
          <description>Subjects may receive a pill with no medicine.</description>
        </group>
        <group group_id="E2">
          <title>Gralise</title>
          <description>Gralise (a long acting gabapentinoid)&#xD;
Gralise: Subjects will start at 600mg and titrate up by 600mg a week for two weeks (to 1800mg), then remain on 1800mg steady state dose of medication (or placebo pills) for 2 weeks. If intolerable side effects occur, the dose may be reduced to last tolerable dose at the discretion of the PI. A 2-week down-titration will be used. Subjects will have 1 week of &quot;wash-out&quot; before repeating the above procedure for the other arm of the study (placebo or medication).</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="5"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="5"/>
              </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="1" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Drowsiness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="5"/>
              </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>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>This study was terminated early due to low recruitment. Therefore, the data presented represents a very small sample, with low 'n's in each group. The data tables represent all available data for the small sample.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Director of the Center for Pain Studies</name_or_title>
      <organization>Rehabilitation Institute of Chicago</organization>
      <phone>312.238.5654</phone>
      <email>centerforpainstudies@ric.org</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/NCT01678911
org study id: RIC_Dep_CPP_2012
nct id: NCT01678911
lead sponsor: 
has dmc: Yes
This study is done to investigate the pain relieving effects of the study drug Gralise (a
      novel long acting gabapentinoid) for people who experience chronic pelvic pain. Subjects with
      Irritable Bowel Syndrome, Interstitial Cystitis, Ulcerative Colitis, and Prostatitis will be
      recruited. The purpose of this research is to look at how the study drug can be used to
      benefit people who experience this type of pain. This is a phase IV study done to study the
      safety and effectiveness of the drug. At this point the drug has been approved by the Food
      and Drug Administration and has been reported to be well tolerated and effective in the
      treatment of various chronic pain conditions, particularly in neuropathic pain. About 36
      subjects will take part in this study.
As a participant in this study, you will be asked to come to the Rehabilitation Institute of
      Chicago (RIC), Center for Pain Studies (446 E Ontario St. Suite 1011, Chicago, IL 60611).
      Your part in this study will last for 15 weeks and will involve 4 visits to the
      Rehabilitation Institute of Chicago and anywhere from weekly phone calls to phone calls every
      other day.

      If you are in this study, you will be placed in one of two study groups: one group will
      receive the study drug followed by a placebo and the second group will receive a placebo
      followed by the study drug. The amount of weeks on placebo versus the study drug will not be
      equal. You will be assigned a study group by chance using a process similar to the flip of a
      coin. This process is called randomization. Neither you nor the study staff will select the
      group you will be in. However, if you have a medical emergency, we can get this information.
      A placebo looks like the study drug but is an inactive substance that has no medication.
      Researchers use a placebo to see if the study drug works better or is safer than not taking
      anything.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: McGill Pain Questionnaire - Short Form
time frame: 4 Visits over a 15 week period
description: The MPQ-SF is a well-validated pain measure that permits separation of the sensory and affective components of pain, which are averaged to compute a total score. The scale ranges from 0-10 (0=no pain, 10=the most pain).
measure: Pain Anxiety Symptoms Scale
time frame: 4 Visits over an 8 week period
description: The Pain Anxiety Symptoms Scale (PASS) is an anxiety scale from 0 - 100, where 0 = no anxiety and 100 = the most anxiety.
measure: Pain Disability Index
time frame: 4 visits over an 8 week period
description: The PDI is a seven-item, validated instrument that assesses perceived disability in seven key life areas. It provides a total disability score, and is an indirect measure of self efficacy. The Pain Disability Scale is a scale from 0 - 70, where 0 = no Disability and 70 = the most Disability.
measure: Center for Epidemiologic Studies Depression Scale
time frame: 4 visits over 15 week period
description: The CES-D 10 is a 10-item questionnaire that has been validated for the assessment of depressive symptomatology. The Depression Scale is a scale with a sum score from 0 - 30, where 0 = no Depression and 30 = the most Depression.
measure: Patient Global Impression of Change
time frame: 4 Visits over 15 weeks
description: Patient Global Impression of Change is a self-report questionnaire on which patient indicate their perceived impression of change since the start of the study given the following options: Very Much Improved, Much Improved, Minimally Improved, No Change, Minimally Worse, Much Worse, or Very much Worse.
arm group label: Placebo then Gralise
arm group type: Placebo Comparator
description: Subjects may receive a pill with no medicine (placebo) for phase 1. Subject washout, then cross over to Gralise in Phase 2.
arm group label: Gralise then Placebo
arm group type: Active Comparator
description: Subjects recieve Gralise (a long acting gabapentinoid) for phase 1.Subject washout, then cross over to placebo in Phase 2.
intervention type: Drug
intervention name: Gralise
description: Subjects will start at 600mg and titrate up by 600mg a week for two weeks (to 1800mg), then remain on 1800mg steady state dose of medication (or placebo pills) for 2 weeks. If intolerable side effects occur, the dose may be reduced to last tolerable dose at the discretion of the PI. A 2-week down-titration will be used. Subjects will have 1 week of "wash-out" before repeating the above procedure for the other arm of the study (placebo or medication).
arm group label: Gralise then Placebo
arm group label: Placebo then Gralise
other name: Gabapentin
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Norman Harden, MD
role: Principal Investigator
affiliation: Shirley Ryan AbilityLab
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Shirley Ryan AbilityLab
investigator full name: Dr. Norman Harden
investigator title: Director, Center for Pain Studies
mesh term: Colitis
mesh term: Colitis, Ulcerative
mesh term: Irritable Bowel Syndrome
mesh term: Cystitis
mesh term: Cystitis, Interstitial
mesh term: Prostatitis
mesh term: Pelvic Pain
mesh term: Gabapentin
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: This study was terminated early due to low recruitment. Therefore, the data presented represents a very small sample, with low 'n's in each group. The data tables represent all available data for the small sample.
point of contact: 