Suspended

Topical Haloperidol: Evidence of Absorption After Topical Administration

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Haloperidol

+ Placebo

Drug
Who is being recruted

Signs and Symptoms+2

+ Signs and Symptoms, Digestive

+ Pathological Conditions, Signs and Symptoms

From 18 to 70 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledEarly Phase 1
Interventional
Study Start: March 2012
See protocol details

Summary

Principal SponsorEric E. Prommer
Last updated: March 17, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2012

Actual date on which the first participant was enrolled.

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

NCT01684969
Principal SponsorEric E. Prommer
Last updated: March 17, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Signs and SymptomsSigns and Symptoms, DigestivePathological Conditions, Signs and SymptomsNauseaVomiting

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
intravenous haloperidol pharmacokinetics

Group II

Placebo

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available.
SuspendedNo study centers