<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/NCT01684969</url>
  </required_header>
  <id_info>
    <org_study_id>11-005661</org_study_id>
    <nct_id>NCT01684969</nct_id>
  </id_info>
  <brief_title>Evidence of Haloperidol Absorption After Topical Administration</brief_title>
  <official_title>Topical Haloperidol: Evidence of Absorption After Topical Administration</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eric E. Prommer</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This will be a blinded study to compare the absorption of topical haloperidol with placebo&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    lack of accrual and funding is about to expire.&#xD;
  </why_stopped>
  <start_date>March 2012</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">May 2013</primary_completion_date>
  <phase>Early Phase 1</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To measure the pharmacokinetics levels of haloperidol after topical administration compared with intravenous administration.</measure>
    <time_frame>baseline to 240 minutes after administration.</time_frame>
    <description>Measuring either the presence of absence of haloperidol</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Nausea</condition>
  <condition>Vomiting</condition>
  <arm_group>
    <arm_group_label>intravenous haloperidol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>intravenous haloperidol pharmacokinetics</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Haloperidol</intervention_name>
    <description>0.5 mg iv x one dose</description>
    <arm_group_label>intravenous haloperidol</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>0.5 mg iv , one dose</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Age: patient must be 18 years or older and less than 70 years of age.&#xD;
&#xD;
          -  Provision of informed consent&#xD;
&#xD;
          -  No previous adverse reaction to haloperidol&#xD;
&#xD;
          -  No current use of haloperidol&#xD;
&#xD;
          -  Good health&#xD;
&#xD;
          -  No alcohol within 24 hours of the study&#xD;
&#xD;
          -  No significant cardiovascular, gastrointestinal, hematologic, neurologic, renal,&#xD;
             hepatic or pulmonary disease.&#xD;
&#xD;
          -  Normal neurologic exam&#xD;
&#xD;
        Exclusionary Criteria&#xD;
&#xD;
          -  Evidence of any other significant clinical disorder or laboratory finding that makes&#xD;
             it undesirable for the patient to participate in the study&#xD;
&#xD;
          -  Recent cerebral trauma&#xD;
&#xD;
          -  Study will exclude women who are pregnant and/or nursing&#xD;
&#xD;
          -  Women who are of child bearing potential must have a negative urine pregnancy test.&#xD;
&#xD;
          -  History of seizures&#xD;
&#xD;
          -  Taking medications that can interact with haloperidol&#xD;
&#xD;
          -  Subjects with significant cardiovascular (cardiac conduction deficits),&#xD;
             gastrointestinal, hematologic, neurologic, renal, hepatic or pulmonary disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eric Prommer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>March 19, 2012</study_first_submitted>
  <study_first_submitted_qc>September 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 13, 2012</study_first_posted>
  <last_update_submitted>March 16, 2016</last_update_submitted>
  <last_update_submitted_qc>March 16, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 17, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Eric E. Prommer</investigator_full_name>
    <investigator_title>Assistant Professor of Medicine, College of Medicine</investigator_title>
  </responsible_party>
  <keyword>Nausea</keyword>
  <keyword>vomiting</keyword>
  <keyword>gastrointestinal symptoms</keyword>
  <keyword>palliative care</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>Haloperidol</mesh_term>
    <mesh_term>Haloperidol decanoate</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/NCT01684969
org study id: 11-005661
nct id: NCT01684969
lead sponsor: 
has dmc: No
This will be a blinded study to compare the absorption of topical haloperidol with placebo
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: To measure the pharmacokinetics levels of haloperidol after topical administration compared with intravenous administration.
time frame: baseline to 240 minutes after administration.
description: Measuring either the presence of absence of haloperidol
arm group label: intravenous haloperidol
arm group type: Active Comparator
description: intravenous haloperidol pharmacokinetics
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Haloperidol
description: 0.5 mg iv x one dose
arm group label: intravenous haloperidol
intervention type: Drug
intervention name: Placebo
description: 0.5 mg iv , one dose
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Eric Prommer, MD
role: Principal Investigator
affiliation: Mayo Clinic
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Mayo Clinic
investigator full name: Eric E. Prommer
investigator title: Assistant Professor of Medicine, College of Medicine
mesh term: Nausea
mesh term: Vomiting
mesh term: Haloperidol
mesh term: Haloperidol decanoate