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Status: Withdrawn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
Summary
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Starting date: March 2012
Last updated: June 24, 2013
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