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

Tracking Information

First Received Date ^ICMJE

December 27, 2007

Last Updated Date

January 9, 2008

Start Date ^ICMJE

March 2005

Estimated Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00590317 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Ondansetron vs Prochlorperazine for Nausea and Vomiting in the Emergency Department

Official Title ^ICMJE

Ondansetron vs Prochlorperazine for Nausea and Vomiting in the Emergency Department

Brief Summary

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

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

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Single Group Assignment

Condition ^ICMJE

Nausea and Vomiting

Intervention ^ICMJE

Drug: Prochlorperazine
Drug: Ondansetron

Study Arms / Comparison Groups

Active Comparator: Patients receiving Prochlorperazine
Active Comparator: Ondansetron

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

150

Completion Date

Estimated Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00590317

Responsible Party

Daniel Wu, MD, Emory University

Study ID Numbers ^ICMJE

998-2005 (Emory IRB)

Study Sponsor ^ICMJE

Emory University

Collaborators ^ICMJE

Investigators ^ICMJE

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

Information Provided By

Emory University

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP