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Comparison of Adding EMEND to PONV/PDNV Treatment Regimen

Primary Purpose

Postoperative Nausea and Vomiting

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

aprepitant

About this trial

This is an interventional prevention trial for Postoperative Nausea and Vomiting focused on measuring Nausea and Vomiting

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

EMEND Added to the Treatment Regimen for Post-Discharge and Post-Operative Nausea and Vomiting

Standard Treatment Regimen for Post-Discharge and Post-Operative Nausea and Vomiting

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01186029

First Posted

August 19, 2010

Last Updated

August 10, 2023

Sponsor

University of Nebraska

1. Study Identification

Unique Protocol Identification Number

NCT01186029

Brief Title

Comparison of Adding EMEND to PONV/PDNV Treatment Regimen

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Withdrawn

Why Stopped

It didn't get IRB approval.

Study Start Date

October 2010 (Anticipated)

Primary Completion Date

September 1, 2011 (Actual)

Study Completion Date

September 1, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Nebraska

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Nausea and Vomiting

Keywords

Nausea and Vomiting

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

EMEND Added to the Treatment Regimen for Post-Discharge and Post-Operative Nausea and Vomiting

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Standard Treatment Regimen for Post-Discharge and Post-Operative Nausea and Vomiting

Arm Type

No Intervention

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

aprepitant

Other Intervention Name(s)

EMEND

Intervention Description

Emend 40mg by mouth 30 minutes before procedure x 1

Primary Outcome Measure Information:

Title

EMEND Added to Standard Treatment of Post-operative and Post-Discharge Nausea and Vomiting

Description

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

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maria A Michaelis, MD

Organizational Affiliation

University of Nebraska

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Comparison of Adding EMEND to PONV/PDNV Treatment Regimen

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