NCT00475306

Brief Summary

Metoclopramide is a dopamine antagonist frequently used for the treatment of nausea, vomiting, and migraine headaches in Emergency Departments. However, little research has focused on the optimal dose of metoclopramide for treatment of nausea in the emergency department. We propose a randomized, double-blind, placebo controlled trial to investigate the optimal dose of metoclopramide for treatment of nausea.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
289

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2007

Shorter than P25 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

May 1, 2007

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

May 16, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 21, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
4.9 years until next milestone

Results Posted

Study results publicly available

December 31, 2012

Completed
Last Updated

December 31, 2012

Status Verified

November 1, 2012

Enrollment Period

9 months

First QC Date

May 16, 2007

Results QC Date

July 11, 2011

Last Update Submit

November 28, 2012

Conditions

NauseaExtrapyramidal Symptoms

Keywords

MetoclopramideNauseaAkathisiaEmergency department

Outcome Measures

Primary Outcomes (1)

  • Nausea Scale

    Patients were asked to report their level of nausea on a scale for 0 to 10, with 0 representing no nausea and 10 the worst nausea imaginable

    60 minutes

Secondary Outcomes (1)

  • Number of Participants With Akathisia

    60 minutes

Study Arms (4)

Metoclopramide 20+diphenhydramine

ACTIVE COMPARATOR

Metoclopramide 20 mg + diphenhydramine, delivered intravenously over 15 minutes

Drug: Diphenhydramine 25 mgDrug: Metoclopramide 20 mg

Metoclopramide 20+placebo

ACTIVE COMPARATOR

Metoclopramide 20 mg + placebo, delivered intravenously over 15 minutes

Drug: PlaceboDrug: Metoclopramide 20 mg

Metoclopramide 10 + placebo

ACTIVE COMPARATOR

Metoclopramide 10mg + placebo, delivered intravenously over 15 minutes

Drug: metoclopramide 10 mgDrug: Placebo

Metoclopramide 10+diphenhydramine

ACTIVE COMPARATOR

Metoclopramide 10 mg + diphenhydramine 25 mg, delivered intravenously over 15 minutes

Drug: metoclopramide 10 mgDrug: Diphenhydramine 25 mg

Interventions

metoclopramide 10 mgDRUG

an anti-emetic medication

Metoclopramide 10 + placeboMetoclopramide 10+diphenhydramine
Diphenhydramine 25 mgDRUG

used for prophylaxis against akathisia

Metoclopramide 10+diphenhydramineMetoclopramide 20+diphenhydramine
PlaceboDRUG

placebo

Metoclopramide 10 + placeboMetoclopramide 20+placebo
Metoclopramide 20 mgDRUG

Metoclopramide 20 mg

Metoclopramide 20+diphenhydramineMetoclopramide 20+placebo

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • primary or secondary complaints of nausea/vomiting
  • age 21-65

You may not qualify if:

  • pregnancy
  • use of anti-histamine or dopamine antagonist as outpatient and/or within last 24 hours of presentation
  • previous adverse reaction to study medications
  • use of opioid medications prior to study start time within that ED visit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

NauseaPsychomotor AgitationEmergencies

Interventions

MetoclopramideDiphenhydramine

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsDyskinesiasNeurologic ManifestationsNervous System DiseasesPsychomotor DisordersNeurobehavioral ManifestationsAberrant Motor Behavior in DementiaBehavioral SymptomsBehaviorDisease AttributesPathologic Processes

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic Chemicalspara-AminobenzoatesAminobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsChlorobenzoatesHydroxybenzoate EthersHydroxybenzoatesHydroxy AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenyl EthersPhenolsEthylaminesAminesBenzhydryl Compounds

Results Point of Contact

Title
Dr. BW Friedman
Organization
Montefiore Medical Center
befriedm@montefiore.org
718-920-6626

Study Officials

  • Benjamin W Friedman, MD

    Montefiore Medical Center

    PRINCIPAL INVESTIGATOR

  • Brooke Bender, MD

    Albert Einstein College of Medicine

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

May 16, 2007

First Posted

May 21, 2007

Study Start

May 1, 2007

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

December 31, 2012

Results First Posted

December 31, 2012

Record last verified: 2012-11

Locations

US(1)