NCT00429832

Brief Summary

This was a trial comparing two commonly used medications for nausea and vomiting, ondansetron and promethazine, in the Emergency Department.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2003

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 1, 2007

Completed
Last Updated

February 1, 2007

Status Verified

January 1, 2007

First QC Date

January 31, 2007

Last Update Submit

January 31, 2007

Conditions

NauseaVomiting

Keywords

Nausea, vomiting, antiemetic

Outcome Measures

Primary Outcomes (1)

  • Reduction in nausea on a VAS.

Secondary Outcomes (4)

  • Change in sedation on a VAS

  • Change in anxiety on a VAS

  • Need for rescue medication at 30 minutes

  • Patient satisfaction at follow-up

Interventions

OndansetronDRUG
promethazineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 or older
  • Chief complaint of nausea or vomiting

You may not qualify if:

  • Age less than 18
  • unable to provide informed consent
  • rate nausea at \< 40 mm on 100 mm VAS
  • received antiemetic within 24 hours
  • pregnant or possibly pregnant
  • reported allergy to either study medication
  • received more than 1 liter of intravenous fluids
  • their primary ED physician declined to have patient participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of New Mexico Hospital Emergency Department

Albuquerque, New Mexico, 87131, United States

Location

Related Publications (1)

  • Braude D, Crandall C. Ondansetron versus promethazine to treat acute undifferentiated nausea in the emergency department: a randomized, double-blind, noninferiority trial. Acad Emerg Med. 2008 Mar;15(3):209-15. doi: 10.1111/j.1553-2712.2008.00060.x.

    PMID: 18304050DERIVED

MeSH Terms

Conditions

NauseaVomiting

Interventions

OndansetronPromethazine

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCarbazolesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-RingPropylaminesAminesOrganic ChemicalsPhenothiazinesSulfur Compounds

Study Officials

  • Darren A Braude, MD, MPH

    University of New Mexico

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 31, 2007

First Posted

February 1, 2007

Study Start

October 1, 2003

Study Completion

November 1, 2005

Last Updated

February 1, 2007

Record last verified: 2007-01

Locations

US(1)