Ondansetron vs Prochlorperazine for Nausea and Vomiting in the Emergency Department - Full Text View

Sponsor:	Emory University
Information provided by:	Emory University
ClinicalTrials.gov Identifier:	NCT00590317

Purpose

This study will compare the effect of prochlorperazine and ondansetron for the treatment of nausea and vomiting in the emergency department.

Condition	Intervention	Phase
Nausea and Vomiting	Drug: Prochlorperazine Drug: Ondansetron	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Single Group Assignment
Official Title:	Ondansetron vs Prochlorperazine for Nausea and Vomiting in the Emergency Department

Resource links provided by NLM:

MedlinePlus related topics: Nausea and Vomiting

Drug Information available for: Prochlorperazine Prochlorperazine maleate Ondansetron hydrochloride Ondansetron Prochlorperazine edisylate

U.S. FDA Resources

Further study details as provided by Emory University:

Primary Outcome Measures:

Compare efficacy of treatment for nausea and vomiting in the ED population [ Time Frame: Duration on ED visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Compare side effects between Ondansetron and Prochlorperazaine for treatment of Nausea and vomiting the ED population [ Time Frame: Duration of ED visit ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	March 2005
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A, 1: Active Comparator Patients receiving Prochlorperazine	Drug: Prochlorperazine Patients receiving Prochlorperazine
A, 2: Active Comparator Ondansetron	Drug: Ondansetron Patients receiving Ondansetron

Detailed Description:

Nausea and vomiting can be common symptoms in the emergency department (ED). Antiemetics, agents to treat nausea and vomiting, include phenothiazine derivatives, prokinetic agents, and 5-HT3 antagonists. There have been limited studies on the use of these agents in the ED, and no direct comparisons to 5-HT3 antagonists have been published to date.

Inclusion Criteria:

Patients presenting to the ED with at least one of the following

nausea
vomiting documented in the ED

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Patients presenting to the ED with at least one of the following
Nausea
Vomiting documented in the ED

Exclusion Criteria:

Previous treatment in the ED with Ondansetron, prochlorperazine, promethazine or metaclopramide
Patients with missed last menstrual period
Pregnancy
Age < 18 years old
Treatment with antineoplastic agents within 7 days prior to randomization
Irritable bowel syndrome
Gastroparesis
Suspected gastrointestinal bleed
Suspected intestinal obstruction
Preexisting motor disorder (Restless-leg syndrome or Parkinson's disease)
Traumatic brain injury upon admission to ED
Intracranial hemorrhage upon admission to ED
Patients unable to read, write or communicate in the English language
Patients leaving the ED against medical advice

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00590317

Locations

United States, Georgia
Grady Memorial Hospital	Recruiting
Atlanta, Georgia, United States
Contact: John Patka, Pharm D 404-616-1299 jpatka@gmh.edu
Principal Investigator: John Patka, PharmD
Principal Investigator: Daniel T Wu, MD

Sponsors and Collaborators

Emory University

Investigators

Principal Investigator:	John Patka, PharmD	Grady Memorial Hospital
Principal Investigator:	Daniel T Wu, MD	Emory University

More Information

No publications provided

Responsible Party:	Emory University ( Daniel Wu, MD )
Study ID Numbers:	998-2005 (Emory IRB)
Study First Received:	December 27, 2007
Last Updated:	January 9, 2008
ClinicalTrials.gov Identifier:	NCT00590317 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Prochlorperazine
Disease Attributes
Neurotransmitter Agents
Vomiting
Signs and Symptoms, Digestive
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Antiemetics
Signs and Symptoms
Serotonin Antagonists
Pathologic Processes
Therapeutic Uses
Antipruritics
Nausea

Ondansetron
Dermatologic Agents
Tranquilizing Agents
Gastrointestinal Agents
Central Nervous System Depressants
Dopamine Antagonists
Antipsychotic Agents
Pharmacologic Actions
Serotonin Agents
Autonomic Agents
Emergencies
Anti-Anxiety Agents
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009