Comparison of Adding EMEND to PONV/PDNV Treatment Regimen

NCT ID: NCT01186029

Last Updated: 2024-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-01

Study Completion Date

2011-09-01

Brief Summary

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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

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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

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Postoperative Nausea and Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

aprepitant

Intervention Type DRUG

Emend 40mg by mouth 30 minutes before procedure x 1

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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aprepitant

Emend 40mg by mouth 30 minutes before procedure x 1

Intervention Type DRUG

Other Intervention Names

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EMEND

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Nebraska

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maria A Michaelis, MD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Other Identifiers

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0359-09-FB

Identifier Type: -

Identifier Source: org_study_id

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