NCT01684969

Brief Summary

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

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2012

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2012

Completed
6 months until next milestone

First Posted

Study publicly available on registry

September 13, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

March 17, 2016

Status Verified

March 1, 2016

Enrollment Period

1.2 years

First QC Date

March 19, 2012

Last Update Submit

March 16, 2016

Conditions

NauseaVomiting

Keywords

Nauseavomitinggastrointestinal symptomspalliative care

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (2)

intravenous haloperidol

ACTIVE COMPARATOR

intravenous haloperidol pharmacokinetics

Drug: Haloperidol

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

HaloperidolDRUG

0.5 mg iv x one dose

intravenous haloperidol
PlaceboDRUG

0.5 mg iv , one dose

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

NauseaVomiting

Interventions

Haloperidol

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ButyrophenonesKetonesOrganic Chemicals

Study Officials

  • Eric Prommer, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor of Medicine, College of Medicine

Study Record Dates

First Submitted

March 19, 2012

First Posted

September 13, 2012

Study Start

March 1, 2012

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

March 17, 2016

Record last verified: 2016-03