NauseaPhase 4NCT00778011
Uncomplicated Nausea and Vomiting in the Emergency Department
A Phase 4 study testing Ondansetron and Metoclopramide in people with Nausea and Vomiting, run by WellSpan Health at 1 site in United States.
Trial summary
Nausea and vomiting is a common complaint in the emergency department. Treatment is important for many reasons. In addition to patient comfort, there are adverse effects secondary to vomiting such as dehydration, metabolic alkalosis, Mallory-Weiss tears, and aspiration. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Ondansetron and Metoclopramide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Dec 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- 18 years or older with nausea and at least 1 episode vomiting in the last 12 hours presenting to the York Hospital Emergency Department
Who cannot join
- Patients known to have hypersensitivity to the drugs ondansetron or metoclopramide
- gastrointestinal hemorrhage, mechanical obstruction or perforation
- patients with pheochromocytoma
- seizure disorder
- patients receiving other drugs which are likely to cause extrapyramidal reactions such as butapherones and phenothiazines
- patients experiencing hyperemesis gravidum
Show all 10Show fewer
- patients unable to understand the informed consent (intoxicated, Spanish speaking)
- prior antiemetics within 12 hours
- inability to perform visual analog scale
- renal dialysis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ondansetron 4 mg vs. 2 mg vs. Metoclopramide 10 mg for Nausea and Vomiting in the Emergency Department: A Randomized, Double-Blind Clinical Trial
Nausea and vomiting is a common complaint in the emergency department. Treatment is important for many reasons. In addition to patient comfort, there are adverse effects secondary to vomiting such as dehydration, metabolic alkalosis, Mallory-Weiss tears, and aspiration. Two mediations common used for nausea in ED patients include Ondanesetron and Metoclopramide.
Read the detailed description
This study will compare Ondansetron 4 mg vs 2 mg vs Metoclopramide 10 mg to look for efficacy in nausea and vomiting treatment for patients in the ED with many different causes. We will also look for cost effectiveness as well, since Metoclopramide is much less expensive than Ondansetron, which is less expensive at lower doses. There is little research about nausea medication in the ED literature even though these medications are used frequently in the ED for many causes of nausea.
- Being tested
- Ondansetron, Metoclopramide
- Keywords
- Nausea, Vomiting, Ondansetron, Metoclopramide, Randomized, Double-Blind, nausea and vomiting in the emergency department
- Medical subject headings
- Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OndansetronDrug
Also called Ondansetron 2 mg IV
dosage
OndansetronDrug
Also called Ondansetron 4 mg IV
4 mg
MetoclopramideDrug
Also called Metoclopramide 10 mg IV
10 mg IV
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: Ondansetron |
| 2 | Active comparator | Not described Receives: Drug: Ondansetron |
| 3 | Active comparator | Not described Receives: Drug: Metoclopramide |
What is being measured
The primary outcome is the main question the study is designed to answer.
To delineate whether a high vs low dose of Ondansetron in better as opposed to an alternate medication -- Metoclopramide in the ED setting for uncomplicated nausea and vomiting.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2008 (estimated)
- Study startNov 2005
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- WellSpan Health
- Sponsor type
- University, hospital or other
- Investigators
- Marc Pollack, MD, PhD, Principal investigator, York Hospital Emergency Department Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00778011
- Sponsor's protocol ID
- 0506018
- Status last verified
- Jun 2012
- First submitted
- 22 Oct 2008
- Last updated
- 28 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ondansetron 4 mg vs. 2 mg vs. Metoclopramide 10 mg for Nausea and Vomiting in the Emergency Department: A Randomized, Double-Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT00778011
- Acronym / sponsor ID
- 0506018
- Keywords
- Nausea, Vomiting, Ondansetron, Metoclopramide, Randomized, Double-Blind, nausea and vomiting in the emergency department
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- WellSpan HealthUniversity, hospital or other
- Study start
- Nov 2005
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 23 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Nausea and vomiting is a common complaint in the emergency department. Treatment is important for many reasons. In addition to patient comfort, there are adverse effects secondary to vomiting such as dehydration, metabolic alkalosis, Mallory-Weiss tears, and aspiration. Two mediations common used for nausea in ED patients include Ondanesetron and Metoclopramide.
Detailed description
This study will compare Ondansetron 4 mg vs 2 mg vs Metoclopramide 10 mg to look for efficacy in nausea and vomiting treatment for patients in the ED with many different causes. We will also look for cost effectiveness as well, since Metoclopramide is much less expensive than Ondansetron, which is less expensive at lower doses. There is little research about nausea medication in the ED literature even though these medications are used frequently in the ED for many causes of nausea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Ondansetron |
| 2 | Active comparator | Drug: Ondansetron |
| 3 | Active comparator | Drug: Metoclopramide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 years or older with nausea and at least 1 episode vomiting in the last 12 hours presenting to the York Hospital Emergency Department
Key exclusion criteria (10 listed)
- Patients known to have hypersensitivity to the drugs ondansetron or metoclopramide
- gastrointestinal hemorrhage, mechanical obstruction or perforation
- patients with pheochromocytoma
- seizure disorder
- patients receiving other drugs which are likely to cause extrapyramidal reactions such as butapherones and phenothiazines
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 |
|---|---|---|
| OndansetronAlso: Ondansetron 2 mg IVdosage | Drug | 1 |
| OndansetronAlso: Ondansetron 4 mg IV4 mg | Drug | 2 |
| MetoclopramideAlso: Metoclopramide 10 mg IV10 mg IV | Drug | 3 |
Primary outcome
To delineate whether a high vs low dose of Ondansetron in better as opposed to an alternate medication -- Metoclopramide in the ED setting for uncomplicated nausea and vomiting.
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2012.
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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.
Marc Pollack, MD, PhD principal investigator
York Hospital Emergency Department Physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ondansetron and Metoclopramide in people with Nausea and Vomiting, run by WellSpan Health 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 10 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: finished, as of the sponsor's last update on 28 Jun 2012. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To delineate whether a high vs low dose of Ondansetron in better as opposed to an alternate medication -- Metoclopramide in the ED setting for uncomplicated nausea and vomiting. (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jun 2012.