This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Evidence of Haloperidol Absorption After Topical Administration

This study has been withdrawn prior to enrollment.
(lack of accrual and funding is about to expire.)
Sponsor:
Information provided by (Responsible Party):
Eric E. Prommer, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01684969
First received: March 19, 2012
Last updated: March 16, 2016
Last verified: March 2016
  Purpose
This will be a blinded study to compare the absorption of topical haloperidol with placebo

Condition Intervention Phase
Nausea Vomiting Drug: Haloperidol Drug: Placebo Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Topical Haloperidol: Evidence of Absorption After Topical Administration

Resource links provided by NLM:


Further study details as provided by Eric E. Prommer, Mayo Clinic:

Primary Outcome Measures:
  • To measure the pharmacokinetics levels of haloperidol after topical administration compared with intravenous administration. [ Time Frame: baseline to 240 minutes after administration. ]
    Measuring either the presence of absence of haloperidol


Enrollment: 0
Study Start Date: March 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: intravenous haloperidol
intravenous haloperidol pharmacokinetics
Drug: Haloperidol
0.5 mg iv x one dose
Placebo Comparator: Placebo Drug: Placebo
0.5 mg iv , one dose

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01684969

Sponsors and Collaborators
Eric E. Prommer
Investigators
Principal Investigator: Eric Prommer, MD Mayo Clinic
  More Information

Responsible Party: Eric E. Prommer, Assistant Professor of Medicine, College of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01684969     History of Changes
Other Study ID Numbers: 11-005661
Study First Received: March 19, 2012
Last Updated: March 16, 2016

Keywords provided by Eric E. Prommer, Mayo Clinic:
Nausea
vomiting
gastrointestinal symptoms
palliative care

Additional relevant MeSH terms:
Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Haloperidol
Haloperidol decanoate
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents

ClinicalTrials.gov processed this record on June 28, 2017