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Evidence of Haloperidol Absorption After Topical Administration

Topical Haloperidol: Evidence of Absorption After Topical Administration

Status
Withdrawn
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01684969
Enrollment
0
Registered
2012-09-13
Start date
2012-03-31
Completion date
2013-05-31
Last updated
2016-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nausea, Vomiting

Keywords

Nausea, vomiting, gastrointestinal symptoms, palliative care

Brief summary

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

Interventions

DRUGHaloperidol

0.5 mg iv x one dose

DRUGPlacebo

0.5 mg iv , one dose

Sponsors

Eric E. Prommer
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
To measure the pharmacokinetics levels of haloperidol after topical administration compared with intravenous administration.baseline to 240 minutes after administration.Measuring either the presence of absence of haloperidol

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026