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This study has been withdrawn prior to enrollment.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: June 24, 2013
Last verified: June 2013
  Purpose

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


Condition Intervention Phase
Nausea
Vomiting
Palliative Care
Drug: Haloperidol
Drug: Placebo
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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 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. ] [ Designated as safety issue: No ]
    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
Genders Eligible for Study:   Both
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
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

No publications provided

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: June 24, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by 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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
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 April 16, 2014