Evidence of Haloperidol Absorption After Topical Administration

Topical Haloperidol: Evidence of Absorption After Topical Administration

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

Study Overview

• Status: Withdrawn
• Conditions: Nausea; Vomiting
• Intervention / Treatment: Drug: Haloperidol; Drug: Placebo

• Study Type: Interventional
• Phase: Early Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; 0.5 mg iv , one dose
Active Comparator: intravenous haloperidol; intravenous haloperidol pharmacokinetics	Drug: Haloperidol; 0.5 mg iv x one dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To measure the pharmacokinetics levels of haloperidol after topical administration compared with intravenous administration.	Measuring either the presence of absence of haloperidol	baseline to 240 minutes after administration.

Collaborators and Investigators

• Sponsor: Eric E. Prommer
• Investigators: Principal Investigator: Eric Prommer, MD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: March 19, 2012
• First Submitted That Met QC Criteria: September 10, 2012
• First Posted (Estimate): September 13, 2012

Study Record Updates

• Last Update Posted (Estimate): March 17, 2016
• Last Update Submitted That Met QC Criteria: March 16, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: palliative care; Nausea; vomiting; gastrointestinal symptoms
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Nausea; Vomiting; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Dopamine Agents; Dopamine Antagonists; Anti-Dyskinesia Agents; Haloperidol; Haloperidol decanoate
• Other Study ID Numbers: 11-005661