<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/NCT01668069</url>
  </required_header>
  <id_info>
    <org_study_id>CIP#NMCSD.2011.0151</org_study_id>
    <nct_id>NCT01668069</nct_id>
  </id_info>
  <brief_title>Ondansetron VS Doxylamine and Pyridoxine in Treating Nausea of Pregnancy</brief_title>
  <official_title>Is Zofran Superior to Pyridoxine at Reducing Nausea and Vomiting in Pregnancy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>United States Naval Medical Center, San Diego</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>United States Naval Medical Center, San Diego</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Our purpose is to determine whether ondansetron, a commonly used antiemetic, is equivalent in&#xD;
      efficacy to the combination of pyridoxine and doxylamine, the currently recommended first&#xD;
      line therapy for nausea and vomiting in pregnancy by the American Congress of Obstetricians&#xD;
      and Gynecologists (ACOG). Since both treatments are safe in pregnancy, many physicians are&#xD;
      using ondansetron as first line in practice. Despite this practice and the recommendations&#xD;
      from ACOG, there is not data to suggest that ether practice is superior. This will be the&#xD;
      first prospective, randomized, double blind, controlled trial comparing the two treatments.&#xD;
      We hypothesize that ondansetron will be equally efficacious in reducing nausea and episodes&#xD;
      of emesis. By alleviating nausea and vomiting associated with pregnancy, patients will likely&#xD;
      benefit from less Emergency Department visits, urgent clinic visits, and admissions for&#xD;
      progression to hyperemesis gravidarum.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">April 2013</completion_date>
  <primary_completion_date type="Actual">October 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reduction of nausea on the VAS (Visual Analog Scale)</measure>
    <time_frame>5 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reduction in vomiting on the VAS</measure>
    <time_frame>5 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Any adverse effects caused by the study medications.</measure>
    <time_frame>5 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Vomiting of Pregnancy</condition>
  <arm_group>
    <arm_group_label>Ondansetron</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>study drug</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Doxylamine and Pyridoxine (vitamin B6)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>other nausea treatment in use</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ondansetron</intervention_name>
    <description>Ondansetron 4mg and a placebo capsule to be taken orally every 8 hours for 5 days.</description>
    <arm_group_label>Ondansetron</arm_group_label>
    <other_name>Zofran</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women who are less than 16 weeks pregnant by last menstrual period or ultrasound&#xD;
&#xD;
          -  Greater than 18 years of age&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  No significant visual or hearing impairment&#xD;
&#xD;
          -  Requesting treatment for nausea associated with pregnancy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  If nausea or vomiting preexisted the pregnancy&#xD;
&#xD;
          -  Requires hospitalization at the time of initial enrollment&#xD;
&#xD;
          -  Already taking anti-emetics to include metoclopramide, ondansetron, doxylamine,&#xD;
             pyridoxine, or promethazine&#xD;
&#xD;
          -  The patient has an allergy to either study regimen&#xD;
&#xD;
          -  If they are unable to return for a follow up visit in 1 week&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lauren G Oliveira, DO</last_name>
    <role>Principal Investigator</role>
    <affiliation>United States Naval Medical Center, San Diego</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Naval Medical Center, San Diego</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>August 15, 2012</study_first_submitted>
  <study_first_submitted_qc>August 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 17, 2012</study_first_posted>
  <last_update_submitted>April 4, 2016</last_update_submitted>
  <last_update_submitted_qc>April 4, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 6, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>nausea</keyword>
  <keyword>vomiting</keyword>
  <keyword>pregnancy</keyword>
  <keyword>ondansetron</keyword>
  <keyword>doxylamine</keyword>
  <keyword>vitamin B6</keyword>
  <keyword>pyridoxine</keyword>
  <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>Ondansetron</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT01668069
org study id: CIP#NMCSD.2011.0151
nct id: NCT01668069
lead sponsor: 
has dmc: Yes
Our purpose is to determine whether ondansetron, a commonly used antiemetic, is equivalent in
      efficacy to the combination of pyridoxine and doxylamine, the currently recommended first
      line therapy for nausea and vomiting in pregnancy by the American Congress of Obstetricians
      and Gynecologists (ACOG). Since both treatments are safe in pregnancy, many physicians are
      using ondansetron as first line in practice. Despite this practice and the recommendations
      from ACOG, there is not data to suggest that ether practice is superior. This will be the
      first prospective, randomized, double blind, controlled trial comparing the two treatments.
      We hypothesize that ondansetron will be equally efficacious in reducing nausea and episodes
      of emesis. By alleviating nausea and vomiting associated with pregnancy, patients will likely
      benefit from less Emergency Department visits, urgent clinic visits, and admissions for
      progression to hyperemesis gravidarum.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Reduction of nausea on the VAS (Visual Analog Scale)
time frame: 5 days
measure: Reduction in vomiting on the VAS
time frame: 5 days
measure: Any adverse effects caused by the study medications.
time frame: 5 days
arm group label: Ondansetron
arm group type: Experimental
description: study drug
arm group label: Doxylamine and Pyridoxine (vitamin B6)
arm group type: No Intervention
description: other nausea treatment in use
intervention type: Drug
intervention name: Ondansetron
description: Ondansetron 4mg and a placebo capsule to be taken orally every 8 hours for 5 days.
arm group label: Ondansetron
other name: Zofran
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Lauren G Oliveira, DO
role: Principal Investigator
affiliation: United States Naval Medical Center, San Diego
facility: 
country: United States
responsible party type: Sponsor
mesh term: Nausea
mesh term: Vomiting
mesh term: Ondansetron
sharing ipd: No