Nausea and VomitingPhase 2NCT00590317
Ondansetron vs Prochlorperazine for Nausea and Vomiting in the Emergency Department
A Phase 2 study testing Prochlorperazine and Ondansetron in people with Nausea and Vomiting, run by Emory University at 2 sites in United States.
Trial summary
This study will compare the effect of prochlorperazine and ondansetron for the treatment of nausea and vomiting in the emergency department. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nausea and Vomiting
- What is being tested?
- Prochlorperazine and Ondansetron
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2005to Sep 2008
- Phase
- Phase 2
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients presenting to the ED with at least one of the following
- Nausea
- Vomiting documented in the ED
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Grady Hospital
Atlanta, Georgia, 30303
Grady Memorial Hospital
Atlanta, Georgia
About this study
This study will compare the effect of prochlorperazine and ondansetron for the treatment of nausea and vomiting in the emergency department.
Read the 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
- Conditions
- Nausea and Vomiting
- Being tested
- Prochlorperazine, Ondansetron
- Medical subject headings
- Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProchlorperazineDrug
Patients receiving Prochlorperazine
OndansetronDrug
Patients receiving Ondansetron
| Study group | Role | What they receive |
|---|---|---|
| Prochlorperazine | Active comparator | Patients receiving Prochlorperazine 10mg IV Receives: Drug: Prochlorperazine |
| Ondansetron | Active comparator | Patient receiving Ondansetron 4mg IV Receives: Drug: Ondansetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vomiting at 0 to 120 Min.
Measured: 0 to 120 minutes after receiving medication
Secondary outcomes (2)
Nausea at 0 to 120 Min
100mm Visual Analog scale (VAS) Scale is from 0 mm to 100 mm 0mm = no nausea 100mm = severe nausea
Measured: 0 to 120 minutes after receiving medication
Akithisia at 0 to 120 Min
Measured: 0 to 120 min after receiving medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2008 (estimated)
- Study startMar 2005
- Primary completionSep 2008
- Study completionSep 2008
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.
- Other trials for Nausea and VomitingStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Wu, MD, Emory University
- Investigators
- John Patka, PharmD, Principal investigator, Grady Memorial HospitalDaniel T Wu, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00590317
- Sponsor's protocol ID
- 0998-2005
- Status last verified
- Apr 2014
- First submitted
- 27 Dec 2007
- Last updated
- 19 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ondansetron vs Prochlorperazine for Nausea and Vomiting in the Emergency Department
- ClinicalTrials.gov ID
- NCT00590317
- Acronym / sponsor ID
- 0998-2005
- Conditions
- Nausea and Vomiting
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Mar 2005
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 10 Jan 2008 (estimated)
- Results
- Posted 19 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prochlorperazine | Active comparator | Drug: ProchlorperazinePatients receiving Prochlorperazine 10mg IV |
| Ondansetron | Active comparator | Drug: OndansetronPatient receiving Ondansetron 4mg IV |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients presenting to the ED with at least one of the following
- Nausea
- Vomiting documented in the ED
Key exclusion criteria (14 listed)
- 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
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 |
|---|---|---|
| ProchlorperazinePatients receiving Prochlorperazine | Drug | Prochlorperazine |
| OndansetronPatients receiving Ondansetron | Drug | Ondansetron |
Primary outcome
Vomiting at 0 to 120 Min.
Time frame: 0 to 120 minutes after receiving medication
2 secondary outcomes
Nausea at 0 to 120 Min
Time frame: 0 to 120 minutes after receiving medication
Akithisia at 0 to 120 Min
Time frame: 0 to 120 min after receiving medication
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
John Patka, PharmD principal investigator
Grady Memorial Hospital
Daniel T Wu, MD principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Prochlorperazine and Ondansetron in people with Nausea and Vomiting, run by Emory University at 2 sites 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 3 inclusion and 14 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 19 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 May 2014). 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?
Vomiting at 0 to 120 Min. (time frame: 0 to 120 minutes after receiving medication). 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 19 May 2014.