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Evidence of Haloperidol Absorption After Topical Administration

Information source: Mayo Clinic
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Nausea; Vomiting; Palliative Care

Intervention: Haloperidol (Drug); Placebo (Drug)

Phase: Phase 0

Status: Withdrawn

Sponsored by: Eric E. Prommer

Official(s) and/or principal investigator(s):
Eric Prommer, MD, Principal Investigator, Affiliation: Mayo Clinic


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

Clinical Details

Official title: Topical Haloperidol: Evidence of Absorption After Topical Administration

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: To measure the pharmacokinetics levels of haloperidol after topical administration compared with intravenous administration.


Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.


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.

Locations and Contacts

Additional Information

Starting date: March 2012
Last updated: June 24, 2013

Page last updated: August 23, 2015

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