NauseaNCT00655642

Comparison of Ondansetron, Metoclopramide and Promethazine for the Treatment of Nausea and Vomiting in the Adult ED

A study testing Ondansetron, Metoclopramide and Promethazine in people with Nausea, run by Vanderbilt University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this study is to compare the effectiveness of ondansetron, metoclopramide, and promethazine for the treatment of nausea in the adult emergency department population. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Nausea
What is being tested?: Ondansetron, Metoclopramide and Promethazine
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 171 participants
Where: 1 siteUnited States
Study dates: Mar 2007to Oct 2008
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

All patients age 18 or older who present to the ED with a complaint requiring antiemetic treatment who do not meet the exclusion criteria.

Who cannot join

Patients less than 18 years of age
Unstable patients with SBP < 90
Patients with a stated or documented allergy to any of the study medications
Patients whose nausea rating if < 40 on the pretreatment VAS scale
Patients who have received a commonly accepted antiemetic within the previous 24 hours
Patients unwilling or unable to complete the assessment tool before and 30 minutes after study drug dosing

Trial locations and contacts

1 site in 1 country.

United States1 site

Vanderbilt University Medical Center
Nashville, Tennessee, 37240

Other trials in United States

About this study

Official title: A Randomized, Double Blind, and Placebo-Controlled Trial Comparing Ondansetron, Metoclopramide and Promethazine for the Treatment of Nausea and Vomiting in the Adult Emergency Department.

The purpose of this study is to compare the effectiveness of ondansetron, metoclopramide, and promethazine for the treatment of nausea in the adult emergency department population.

We hypothesize that a single intravenous dose of ondansetron is more effective in reducing nausea than a single IV dose of metoclopramide, promethazine or normal saline placebo in undifferentiated adult emergency department patients.

Conditions: Nausea
Being tested: Ondansetron, Metoclopramide, Promethazine, Normal Saline
Medical subject headings: Nausea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OndansetronDrug
4 mg intravenous dose administered over 2 minutes through a peripheral intravenous catheter
MetoclopramideDrug
10 mg intravenous dose administered over 2 minutes through a peripheral intravenous catheter
PromethazineDrug
12.5 mg intravenous dose administered over 2 minutes through a peripheral intravenous catheter
Normal SalineDrug
Volume matched isotonic sodium chloride solution dose administered over 2 minutes through a peripheral intravenous catheter

Study groups in NCT00655642
Study group	Role	What they receive
Ondansetron	Active comparator	Ondansetron 4 mg intravenous administration Receives: Drug: Ondansetron
Metoclopramide	Active comparator	Metoclopramide 10 mg intravenous administration Receives: Drug: Metoclopramide
Promethazine	Active comparator	Promethazine 10 mg intravenous administration Receives: Drug: Promethazine
Saline Placebo	Placebo comparator	Volume-matched saline placebo Receives: Drug: Normal Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Visual Analog Scale (VAS) Score for Nausea. This Was Calculated by Subtracting the Patient's Reported Score on the 30 Minute VAS From the Patient's Reported VAS Score on Their Baseline VAS.
Participants independently rated their nausea severity on separate scales at the baseline and 30-minute evaluations to prevent the baseline VAS score from influencing the 30-minute mark. The VAS had the words "Least Severe" on the left and "Most Severe" on the right. The possible values range from 0 to 100mm with 0 at the "Least Severe" extreme and 100 at the "Most Severe" extreme. Investigators instructed the participant to draw a single vertical line through the point on the 100mm scale that corresponded to their nausea severity at the times of measurement (Baseline and 30 minutes).
Measured: Baseline and 30 minute assessments

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2007Oct 2008

First posted10 Apr 2008 (estimated)
Study startMar 2007
Primary completionOct 2008
Study completionOct 2008

Why it stopped: Conditional analysis showed observed differences were significantly less than power calculations

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for NauseaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 171 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00655642
Sponsor's protocol ID: VUMC 0612369
Status last verified: Sep 2013
First submitted: 4 Apr 2008
Last updated: 30 Oct 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Barrett TW, DiPersio DM, Jenkins CA, Jack M, McCoin NS, Storrow AB, Singleton LM, Lee P, Zhou C, Slovis CM. A randomized, placebo-controlled trial of ondansetron, metoclopramide, and promethazine in adults. Am J Emerg Med. 2011 Mar;29(3):247-55. doi: 10.1016/j.ajem.2009.09.028. Epub 2010 Mar 26.
PubMed 20825792

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Netupitant/Palonosetron for Prevention of Nausea and Vomiting in Breast Cancer ADC Therapy
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BMT-08: A Comparative Effectiveness Study of Transdermal Granisetron to Ondansetron
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Manual Acupuncture for Intradialytic Nausea and Vomiting in Patients Undergoing Hemodialysis
Intradialytic Nausea and Vomiting, Chronic Kidney Disease
Not yet recruitingObservational study
Preoperative Gastric Volume and PONV in Pediatric Appendectomy Cases
Postoperative Nausea and Vomiting
RecruitingPhase 2
A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer
Nausea, Vomiting

All Nausea trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double Blind, and Placebo-Controlled Trial Comparing Ondansetron, Metoclopramide and Promethazine for the Treatment of Nausea and Vomiting in the Adult Emergency Department.
ClinicalTrials.gov ID: NCT00655642
Acronym / sponsor ID: VUMC 0612369
Conditions: Nausea
Study type: Interventional
Recruitment status: TerminatedReason stopped: Conditional analysis showed observed differences were significantly less than power calculations
Enrolment: 171 participants (actual)
Lead sponsor: Vanderbilt UniversityUniversity, hospital or other
Study start: Mar 2007
Primary completion: Oct 2008 (actual)
Study completion: Oct 2008 (actual)
First posted: 10 Apr 2008 (estimated)
Results: Posted 9 May 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to compare the effectiveness of ondansetron, metoclopramide, and promethazine for the treatment of nausea in the adult emergency department population.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Ondansetron	Active comparator	Drug: OndansetronOndansetron 4 mg intravenous administration
Metoclopramide	Active comparator	Drug: MetoclopramideMetoclopramide 10 mg intravenous administration
Promethazine	Active comparator	Drug: PromethazinePromethazine 10 mg intravenous administration
Saline Placebo	Placebo comparator	Drug: Normal SalineVolume-matched saline placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

All patients age 18 or older who present to the ED with a complaint requiring antiemetic treatment who do not meet the exclusion criteria.

Key exclusion criteria (6 listed)

Patients less than 18 years of age
Unstable patients with SBP < 90
Patients with a stated or documented allergy to any of the study medications
Patients whose nausea rating if < 40 on the pretreatment VAS scale
Patients who have received a commonly accepted antiemetic within the previous 24 hours

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ondansetron4 mg intravenous dose administered over 2 minutes through a peripheral intravenous catheter	Drug	Ondansetron
Metoclopramide10 mg intravenous dose administered over 2 minutes through a peripheral intravenous catheter	Drug	Metoclopramide
Promethazine12.5 mg intravenous dose administered over 2 minutes through a peripheral intravenous catheter	Drug	Promethazine
Normal SalineVolume matched isotonic sodium chloride solution dose administered over 2 minutes through a peripheral intravenous catheter	Drug	Saline Placebo

Primary outcome

Change in Visual Analog Scale (VAS) Score for Nausea. This Was Calculated by Subtracting the Patient's Reported Score on the 30 Minute VAS From the Patient's Reported VAS Score on Their Baseline VAS.
Time frame: Baseline and 30 minute assessments
Participants independently rated their nausea severity on separate scales at the baseline and 30-minute evaluations to prevent the baseline VAS score from influencing the 30-minute mark. The VAS had the words "Least Severe" on the left and "Most Severe" on the right. The possible values range from 0 to 100mm with 0 at the "Least Severe" extreme and 100 at the "Most Severe" extreme. Investigators instructed the participant to draw a single vertical line through the point on the 100mm scale that corresponded to their nausea severity at the times of measurement (Baseline and 30 minutes).

Results and safety

Results posted to the registry on 9 May 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ondansetron	42	41
Metoclopramide	43	40
Promethazine	45	43
Placebo	41	39

Primary outcome: Change in Visual Analog Scale (VAS) Score for Nausea. This Was Calculated by Subtracting the Patient's Reported Score on the 30 Minute VAS From the Patient's Reported VAS Score on Their Baseline VAS.

Time frame: Baseline and 30 minute assessments. Median (Inter-Quartile Range). Unit: millimeter

Measure	Ondansetron n = 41	Metoclopramide n = 40	Promethazine n = 43	Placebo n = 39
Value	-22.0 (-43.0 to -8.0)	-30.0 (-43.5 to -20.0)	-29.0 (-46.5 to -9.5)	-16.0 (-45.0 to -1.5)

Ondansetron vs Metoclopramide vs Promethazine vs Placebo: Median Difference (Final Values): 12, p = 0.16, Kruskal-Wallis

Population analysed: Analysis was performed on all patients who received one of the four treatments and completed the 30-minute VAS assessment. The trial was anticipated to require 18 months to achieve full accrual of patients (n=600). Given that we were at 30% information fraction at 17 months, an unplanned interim analysis was done.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ondansetron	0 of 41 (0%)	10 of 41 (24.4%)	Not reported
Metoclopramide	0 of 40 (0%)	18 of 40 (45%)	Not reported
Promethazine	0 of 43 (0%)	14 of 43 (32.6%)	Not reported
Placebo	0 of 39 (0%)	9 of 39 (23.1%)	Not reported

Limitations and caveats (from the sponsor): Early termination resulted in failure to meet our predetermined sample size.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 20825792Barrett TW, DiPersio DM, Jenkins CA, Jack M, McCoin NS, Storrow AB, Singleton LM, Lee P, Zhou C, Slovis CM. A randomized, placebo-controlled trial of ondansetron, metoclopramide, and promethazine in adults. Am J Emerg Med. 2011 Mar;29(3):247-55. doi: 10.1016/j.ajem.2009.09.028. Epub 2010 Mar 26.

Related trials for Nausea

Not yet recruitingPhase 2
Netupitant/Palonosetron for Prevention of Nausea and Vomiting in Breast Cancer ADC Therapy
Breast Cancer
RecruitingPhase 4
BMT-08: A Comparative Effectiveness Study of Transdermal Granisetron to Ondansetron
Nausea With Vomiting Chemotherapy-Induced
Not yet recruiting
Manual Acupuncture for Intradialytic Nausea and Vomiting in Patients Undergoing Hemodialysis
Intradialytic Nausea and Vomiting, Chronic Kidney Disease
Not yet recruitingObservational study
Preoperative Gastric Volume and PONV in Pediatric Appendectomy Cases
Postoperative Nausea and Vomiting
RecruitingPhase 2
A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer
Nausea, Vomiting

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Tyler W Barrett, MD principal investigator

Vanderbilt University Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Ondansetron, Metoclopramide and Promethazine in people with Nausea, run by Vanderbilt University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 May 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Visual Analog Scale (VAS) Score for Nausea. This Was Calculated by Subtracting the Patient's Reported Score on the 30 Minute VAS From the Patient's Reported VAS Score on Their Baseline VAS. (time frame: Baseline and 30 minute assessments). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00655642, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2013.