<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/NCT02977741</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00037144</org_study_id>
    <nct_id>NCT02977741</nct_id>
  </id_info>
  <brief_title>Olanzapine for the Treatment of Refractory Chronic Nausea and Vomiting</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective, observational study evaluating the effect of olanzapine for the treatment of&#xD;
      refractory chronic nausea and vomiting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients will be identified who are seen in the Johns Hopkins Gastroenterology Clinic, suffer&#xD;
      from chronic nausea and vomiting that is refractory to both prokinetic and antiemetic&#xD;
      medications, and are being prescribed olanzapine for treatment of nausea and vomiting.&#xD;
      Patients who meet criteria will be enrolled and their gastrointestinal symptoms, quality of&#xD;
      life, and psychological symptoms will be assessed by various questionnaires and followed over&#xD;
      the course of 3 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Inability to recruit patients&#xD;
  </why_stopped>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">December 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Nausea and vomiting severity</measure>
    <time_frame>3 months</time_frame>
    <description>Effect of olanzapine on refractory nausea and vomiting as per changes in patient scoring of the severity of nausea and vomiting on a daily visual analog scale (VAS). Scores range from 0-100, with higher scores indicating more severe symptoms.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Severity of upper gastrointestinal symptoms</measure>
    <time_frame>3 months</time_frame>
    <description>The effect of olanzapine on severity of upper gastrointestinal symptoms, assessed by the NIH Patient-Reported Outcomes Measurement Information System (PROMIS) Gastrointestinal Symptom Scales questionnaire. The questionnaire is 60-item GI symptom questionnaire covering 8 domains: Gastroesophageal reflux (13 items), disrupted swallowing (7 items), diarrhea (5 items), bowel incontinence/soilage (4 items), nausea and vomiting (4 items), constipation (9 items), belly pain (6 items), and gas/bloat/flatulence (12 items). Higher scores indicate more severe symptoms. A scoring service is used to convert the raw scores to a final T-score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life and functional status</measure>
    <time_frame>3 months</time_frame>
    <description>The effect of olanzapine on quality of life and functional status, assessed by the EuroQol 5 Dimension (EQ-5D) questionnaire. The EQ-5D descriptive system consists of five dimensions: Mobility, Self-care, Usual activities, Pain/discomfort, Anxiety/depression. Scores range from 5-25, with higher scores indicating more severe symptoms/decreased quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptom-specific anxiety</measure>
    <time_frame>3 months</time_frame>
    <description>The effect of olanzapine on patient's overall gastrointestinal symptom-specific anxiety, assessed by the Visceral Sensitivity Index (VSI) questionnaire. The VSI is an instrument to assess gastrointestinal-specific anxiety, the cognitive, affective, and behavioral response to fear of gastrointestinal sensations, symptoms, and the context in which these visceral sensations and symptoms occur. The questionnaire consists of 15 questions, each scored 1-6. Total scores range from 15-90, with lower scores indicating more severe symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of depression</measure>
    <time_frame>3 months</time_frame>
    <description>Presence of depression in participants both before initiating olanzapine and after starting olanzapine, assessed by the Patient Health Questionnaire (PHQ-4) at baseline, 1 month, and 3 months. Total score is determined by adding together the scores for each of the 4 items. Scores range from 0-12 and are rated as normal (0-2), mild depression (3-5), moderate depression (6-8), and severe depression (9-12).</description>
  </secondary_outcome>
  <enrollment type="Actual">0</enrollment>
  <condition>Nausea</condition>
  <condition>Vomiting</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Olanzapine</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients who are seen in the Johns Hopkins Center for Neurogastroenterology, have&#xD;
        been identified by the healthcare provider (physician, nurse practitioner, physician&#xD;
        assistant) as having refractory chronic nausea and vomiting that has failed a trial of&#xD;
        typical treatments (both anti-emetics and pro kinetics), and who will be prescribed&#xD;
        olanzapine for the treatment of chronic nausea and vomiting&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-65 years of age&#xD;
&#xD;
          -  Able to communicate in English without aid of interpreter&#xD;
&#xD;
          -  Have chronic refractory nausea, meeting each of the following criteria:&#xD;
&#xD;
               1. Baseline nausea and vomiting score on VAS of 25mm or greater&#xD;
&#xD;
               2. Duration symptoms of at least 6 months (does not have to be contiguous)&#xD;
&#xD;
               3. Intolerance to or inadequate response to prior treatment with both 1) ondansetron&#xD;
                  or another serotonin (5HT3) antagonist and 2) metoclopramide or domperidone&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of chemotherapy within the last year&#xD;
&#xD;
          -  Current diagnosis of cancer&#xD;
&#xD;
          -  Pregnant or breastfeeding&#xD;
&#xD;
          -  For females, active efforts to conceive/become pregnant during the time of the study&#xD;
&#xD;
          -  Chronic opioid use (3 times a week or greater use)&#xD;
&#xD;
          -  Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevation of&#xD;
             greater than 2x upper limit of normal (within 3 months of enrollment)&#xD;
&#xD;
          -  Cirrhosis&#xD;
&#xD;
          -  Unable or unwilling to stop using metoclopramide while using olanzapine&#xD;
&#xD;
          -  Concomitant use of other antipsychotics (e.g., haloperidol)&#xD;
&#xD;
          -  Prolonged corrected QT interval (QTc) (&gt;470ms for men and &gt;480ms for women)&#xD;
&#xD;
          -  History of life-threatening arrhythmia&#xD;
&#xD;
          -  Hypokalemia (potassium &lt;3.1) or hypomagnesemia (magnesium &lt;1.2)&#xD;
&#xD;
          -  Metabolic syndrome, defined as per Adult Treatment Panel III criteria&#xD;
&#xD;
          -  Granulocytopenia (absolute neutrophil count &lt;1500)&#xD;
&#xD;
          -  History of tardive dyskinesia&#xD;
&#xD;
          -  History of acute dystonic reaction to medications&#xD;
&#xD;
          -  History of neuroleptic malignant syndrome&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Johns Hopkins University</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>August 16, 2018</last_update_submitted>
  <last_update_submitted_qc>August 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nausea</mesh_term>
    <mesh_term>Vomiting</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Olanzapine</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02977741
org study id: IRB00037144
nct id: NCT02977741
lead sponsor: 
has dmc: No
Prospective, observational study evaluating the effect of olanzapine for the treatment of
      refractory chronic nausea and vomiting.
Patients will be identified who are seen in the Johns Hopkins Gastroenterology Clinic, suffer
      from chronic nausea and vomiting that is refractory to both prokinetic and antiemetic
      medications, and are being prescribed olanzapine for treatment of nausea and vomiting.
      Patients who meet criteria will be enrolled and their gastrointestinal symptoms, quality of
      life, and psychological symptoms will be assessed by various questionnaires and followed over
      the course of 3 months.
observational model: Cohort
time perspective: Prospective
measure: Nausea and vomiting severity
time frame: 3 months
description: Effect of olanzapine on refractory nausea and vomiting as per changes in patient scoring of the severity of nausea and vomiting on a daily visual analog scale (VAS). Scores range from 0-100, with higher scores indicating more severe symptoms.
measure: Severity of upper gastrointestinal symptoms
time frame: 3 months
description: The effect of olanzapine on severity of upper gastrointestinal symptoms, assessed by the NIH Patient-Reported Outcomes Measurement Information System (PROMIS) Gastrointestinal Symptom Scales questionnaire. The questionnaire is 60-item GI symptom questionnaire covering 8 domains: Gastroesophageal reflux (13 items), disrupted swallowing (7 items), diarrhea (5 items), bowel incontinence/soilage (4 items), nausea and vomiting (4 items), constipation (9 items), belly pain (6 items), and gas/bloat/flatulence (12 items). Higher scores indicate more severe symptoms. A scoring service is used to convert the raw scores to a final T-score.
measure: Quality of life and functional status
time frame: 3 months
description: The effect of olanzapine on quality of life and functional status, assessed by the EuroQol 5 Dimension (EQ-5D) questionnaire. The EQ-5D descriptive system consists of five dimensions: Mobility, Self-care, Usual activities, Pain/discomfort, Anxiety/depression. Scores range from 5-25, with higher scores indicating more severe symptoms/decreased quality of life.
measure: Symptom-specific anxiety
time frame: 3 months
description: The effect of olanzapine on patient's overall gastrointestinal symptom-specific anxiety, assessed by the Visceral Sensitivity Index (VSI) questionnaire. The VSI is an instrument to assess gastrointestinal-specific anxiety, the cognitive, affective, and behavioral response to fear of gastrointestinal sensations, symptoms, and the context in which these visceral sensations and symptoms occur. The questionnaire consists of 15 questions, each scored 1-6. Total scores range from 15-90, with lower scores indicating more severe symptoms.
measure: Presence of depression
time frame: 3 months
description: Presence of depression in participants both before initiating olanzapine and after starting olanzapine, assessed by the Patient Health Questionnaire (PHQ-4) at baseline, 1 month, and 3 months. Total score is determined by adding together the scores for each of the 4 items. Scores range from 0-12 and are rated as normal (0-2), mild depression (3-5), moderate depression (6-8), and severe depression (9-12).
intervention type: Drug
intervention name: Olanzapine
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Nausea
mesh term: Vomiting
mesh term: Olanzapine