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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01684969
Other study ID # 11-005661
Secondary ID
Status Withdrawn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Status Withdrawn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


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
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