Evidence of Haloperidol Absorption After Topical Administration

Nausea Clinical Trial

Official title:

Topical Haloperidol: Evidence of Absorption After Topical Administration

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01684969
• Other study ID #: 11-005661
• Status: Withdrawn
• Phase: Phase 0
• First received: March 19, 2012
• Last updated: March 16, 2016
• Start date: March 2012
• Est. completion date: May 2013

Study information

• Verified date: March 2016
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Nausea
• Vomiting

Intervention

Drug:
• Haloperidol
0.5 mg iv x one dose
• Placebo
0.5 mg iv , one dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eric E. Prommer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No