NCT01186029

Brief 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.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2011

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 20, 2010

Completed
1 year until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

August 30, 2024

Status Verified

August 1, 2024

Enrollment Period

Same day

First QC Date

August 19, 2010

Last Update Submit

August 29, 2024

Conditions

Postoperative Nausea and Vomiting

Keywords

Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

  • 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

    1 year

Study Arms (2)

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.

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.

Interventions

aprepitantDRUG

Emend 40mg by mouth 30 minutes before procedure x 1

Also known as: EMEND
EMEND Added to the Treatment Regimen for Post-Discharge and Post-Operative Nausea and Vomiting

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with at least 2 of the common risk factors for PONV/PDNV; patients having a procedure deemed at high risk for PONV/PDNV

You may not qualify if:

  • patients under 19 years of age; pregnant and breast-feeding patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Postoperative Nausea and VomitingNauseaVomiting

Interventions

Aprepitant

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveSigns and Symptoms

Intervention Hierarchy (Ancestors)

MorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Maria A Michaelis, MD

    University of Nebraska

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2010

First Posted

August 20, 2010

Study Start

September 1, 2011

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

August 30, 2024

Record last verified: 2024-08