Postoperative Nausea and VomitingNCT01186029
Comparison of Adding EMEND to PONV/PDNV Treatment Regimen
A study testing aprepitant in people with Postoperative Nausea and Vomiting, run by University of Nebraska.
Trial summary
This study is looking at whether the addition of Aprepitant (Emend), an antiemetic, will provide added efficacy if added to 2 drugs that are already used as a standard of care for post-operative nausea and vomiting and post-discharge nausea and vomiting. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- aprepitant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2011to 1 Sep 2011
- Phase
- Interventional
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with at least 2 of the common risk factors for PONV/PDNV; patients having a procedure deemed at high risk for PONV/PDNV
Who cannot join
- patients under 19 years of age; pregnant and breast-feeding patients
About this study
Official title: A Comparison Study to Determine the Increased Efficacy of Adding EMEND to the Treatment Regimen for Post-Discharge and Post-Operative Nausea and Vomiting
This study is looking at whether the addition of Aprepitant (Emend), an antiemetic, will provide added efficacy if added to 2 drugs that are already used as a standard of care for post-operative nausea and vomiting and post-discharge nausea and vomiting.
Read the detailed description
This study is looking at whether the addition of a fairly new drug for the treatment of post-operative nausea and vomiting (PONV) and post-discharge nausea and vomiting (PDNV) will provide added efficacy if added to 2 drugs that are already used as a standard of care for PONV and PDNV.
The patients that will be looked at will be deemed at higher risk for PONV and PDNV based on the procedure they are having done and/or on patient risk factors.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- aprepitant
- Keywords
- Nausea and Vomiting
- Medical subject headings
- Postoperative Nausea and Vomiting, Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aprepitantDrug
Also called EMEND
Emend 40mg by mouth 30 minutes before procedure x 1
| Study group | Role | What they receive |
|---|---|---|
| EMEND Added to the Treatment Regimen for Post-Discharge and Post-Operative Nausea and Vomiting | Active comparator | The addition of Aprepitant (Emend), an antiemetic, to 2 drugs that are already used as a standard of care for post-operative nausea and vomiting and post-discharge nausea and vomiting. Receives: Drug: aprepitant |
| Standard Treatment Regimen for Post-Discharge and Post-Operative Nausea and Vomiting | No intervention | No addition of Aprepitant (Emend), an antiemetic, to 2 drugs that are already used as a standard of care for post-operative nausea and vomiting and post-discharge nausea and vomiting. |
What is being measured
The primary outcome is the main question the study is designed to answer.
EMEND Added to Standard Treatment of Post-operative and Post-Discharge Nausea and Vomiting
To see if by adding EMEND to a standard treatment regimen for PONV/PDNV, added efficacy will be obtained. To see if there is more efficacy for PONV vs. PDNV by adding EMEND to the treatment regimen
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2010 (estimated)
- Study start1 Sep 2011
- Primary completion1 Sep 2011
- Study completion1 Sep 2011
Why it stopped: It didn't get IRB approval.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria A Michaelis, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01186029
- Sponsor's protocol ID
- 0359-09-FB
- Status last verified
- Aug 2024
- First submitted
- 19 Aug 2010
- Last updated
- 30 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Study to Determine the Increased Efficacy of Adding EMEND to the Treatment Regimen for Post-Discharge and Post-Operative Nausea and Vomiting
- ClinicalTrials.gov ID
- NCT01186029
- Acronym / sponsor ID
- 0359-09-FB
- Conditions
- Postoperative Nausea and Vomiting
- Keywords
- Nausea and Vomiting
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: It didn't get IRB approval.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 1 Sep 2011 (actual)
- Primary completion
- 1 Sep 2011 (actual)
- Study completion
- 1 Sep 2011 (actual)
- First posted
- 20 Aug 2010 (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.
This study is looking at whether the addition of Aprepitant (Emend), an antiemetic, will provide added efficacy if added to 2 drugs that are already used as a standard of care for post-operative nausea and vomiting and post-discharge nausea and vomiting.
Detailed description
This study is looking at whether the addition of a fairly new drug for the treatment of post-operative nausea and vomiting (PONV) and post-discharge nausea and vomiting (PDNV) will provide added efficacy if added to 2 drugs that are already used as a standard of care for PONV and PDNV.
The patients that will be looked at will be deemed at higher risk for PONV and PDNV based on the procedure they are having done and/or on patient risk factors.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EMEND Added to the Treatment Regimen for Post-Discharge and Post-Operative Nausea and Vomiting | Active comparator | Drug: aprepitantThe addition of Aprepitant (Emend), an antiemetic, to 2 drugs that are already used as a standard of care for post-operative nausea and vomiting and post-discharge nausea and vomiting. |
| Standard Treatment Regimen for Post-Discharge and Post-Operative Nausea and Vomiting | No intervention | –No addition of Aprepitant (Emend), an antiemetic, to 2 drugs that are already used as a standard of care for post-operative nausea and vomiting and post-discharge nausea and vomiting. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with at least 2 of the common risk factors for PONV/PDNV; patients having a procedure deemed at high risk for PONV/PDNV
Key exclusion criteria (1 listed)
- patients under 19 years of age; pregnant and breast-feeding patients
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 |
|---|---|---|
| aprepitantAlso: EMENDEmend 40mg by mouth 30 minutes before procedure x 1 | Drug | EMEND Added to the Treatment Regimen for Post-Discharge and Post-Operative Nausea and Vomiting |
Primary outcome
EMEND Added to Standard Treatment of Post-operative and Post-Discharge Nausea and Vomiting
Time frame: 1 year
To see if by adding EMEND to a standard treatment regimen for PONV/PDNV, added efficacy will be obtained. To see if there is more efficacy for PONV vs. PDNV by adding EMEND to the treatment regimen
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
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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.
Maria A Michaelis, MD principal investigator
University of Nebraska
Questions about this trial
What is this clinical trial studying?
A study testing aprepitant in people with Postoperative Nausea and Vomiting, run by University of Nebraska.
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 1 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: withdrawn, as of the sponsor's last update on 30 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
EMEND Added to Standard Treatment of Post-operative and Post-Discharge Nausea and Vomiting (time frame: 1 year). 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 30 Aug 2024.