Comparison of Adding EMEND to PONV/PDNV Treatment Regimen

August 29, 2024 updated by: University of Nebraska

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: EMEND Added to the Treatment Regimen for Post-Discharge and Post-Operative Nausea and Vomiting
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
Emend 40mg by mouth 30 minutes before procedure x 1
Other Names:
  • EMEND
No Intervention: Standard Treatment Regimen for Post-Discharge and Post-Operative Nausea and Vomiting
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
To see if there is more efficacy for PONV vs. PDNV by adding EMEND to the treatment regimen
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nebraska

Investigators

  • Principal Investigator: Maria A Michaelis, MD, University of Nebraska

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2011

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

August 19, 2010

First Submitted That Met QC Criteria

August 19, 2010

First Posted (Estimated)

August 20, 2010

Study Record Updates

Last Update Posted (Actual)

August 30, 2024

Last Update Submitted That Met QC Criteria

August 29, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0359-09-FB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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