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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This study has been withdrawn prior to enrollment.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:
ClinicalTrials.gov Identifier:
NCT01684969
First Posted: September 13, 2012
Last Update Posted: March 17, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eric E. Prommer, Mayo Clinic
  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: Triple (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: March 19, 2012
First Posted: September 13, 2012
Last Update Posted: March 17, 2016
Last Verified: March 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