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Evidence of Haloperidol Absorption After Topical Administration

Primary Purpose

Nausea, Vomiting

Status
Withdrawn
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Haloperidol
Placebo
Sponsored by
Eric E. Prommer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nausea focused on measuring Nausea, vomiting, gastrointestinal symptoms, palliative care

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria

  • Age: patient must be 18 years or older and less than 70 years of age.
  • Provision of informed consent
  • No previous adverse reaction to haloperidol
  • No current use of haloperidol
  • Good health
  • No alcohol within 24 hours of the study
  • No significant cardiovascular, gastrointestinal, hematologic, neurologic, renal, hepatic or pulmonary disease.
  • Normal neurologic exam

Exclusionary Criteria

  • Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study
  • Recent cerebral trauma
  • Study will exclude women who are pregnant and/or nursing
  • Women who are of child bearing potential must have a negative urine pregnancy test.
  • History of seizures
  • Taking medications that can interact with haloperidol
  • Subjects with significant cardiovascular (cardiac conduction deficits), gastrointestinal, hematologic, neurologic, renal, hepatic or pulmonary disease.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    intravenous haloperidol

    Placebo

    Arm Description

    intravenous haloperidol pharmacokinetics

    Outcomes

    Primary Outcome Measures

    To measure the pharmacokinetics levels of haloperidol after topical administration compared with intravenous administration.
    Measuring either the presence of absence of haloperidol

    Secondary Outcome Measures

    Full Information

    First Posted
    March 19, 2012
    Last Updated
    March 16, 2016
    Sponsor
    Eric E. Prommer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01684969
    Brief Title
    Evidence of Haloperidol Absorption After Topical Administration
    Official Title
    Topical Haloperidol: Evidence of Absorption After Topical Administration
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2016
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    lack of accrual and funding is about to expire.
    Study Start Date
    March 2012 (undefined)
    Primary Completion Date
    May 2013 (Actual)
    Study Completion Date
    May 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Eric E. Prommer

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This will be a blinded study to compare the absorption of topical haloperidol with placebo

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Nausea, Vomiting
    Keywords
    Nausea, vomiting, gastrointestinal symptoms, palliative care

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    intravenous haloperidol
    Arm Type
    Active Comparator
    Arm Description
    intravenous haloperidol pharmacokinetics
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Haloperidol
    Intervention Description
    0.5 mg iv x one dose
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    0.5 mg iv , one dose
    Primary Outcome Measure Information:
    Title
    To measure the pharmacokinetics levels of haloperidol after topical administration compared with intravenous administration.
    Description
    Measuring either the presence of absence of haloperidol
    Time Frame
    baseline to 240 minutes after administration.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria Age: patient must be 18 years or older and less than 70 years of age. Provision of informed consent No previous adverse reaction to haloperidol No current use of haloperidol Good health No alcohol within 24 hours of the study No significant cardiovascular, gastrointestinal, hematologic, neurologic, renal, hepatic or pulmonary disease. Normal neurologic exam Exclusionary Criteria Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study Recent cerebral trauma Study will exclude women who are pregnant and/or nursing Women who are of child bearing potential must have a negative urine pregnancy test. History of seizures Taking medications that can interact with haloperidol Subjects with significant cardiovascular (cardiac conduction deficits), gastrointestinal, hematologic, neurologic, renal, hepatic or pulmonary disease.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Eric Prommer, MD
    Organizational Affiliation
    Mayo Clinic
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Evidence of Haloperidol Absorption After Topical Administration

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