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Combination Antiemetic Regimen for Prevention of PONV in Breast Surgery Patients

NCT00738621 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2013-12-19

No results posted yet for this study

Summary

The purpose of this study is to compare the efficacy of the use of oral aprepitant in combination with intravenous ondansetron and dexamethasone with the efficacy provided by the use of oral aprepitant and dexamethasone for preventing vomiting during the first 24-48 hours after breast surgery.

Conditions

  • Postoperative Nausea and Vomiting

Interventions

DRUG

Aprepitant, Dexamethasone, Ondansetron

Aprepitant oral 40mg one dose, dexamethasone IV 4mg one dose, ondansetron 4 mg one dose

DRUG

Aprepitant, Dexamethasone, Placebo

Aprepitant 40mg oral one time, dexamethasone IV 4mg one time placebo one time

Sponsors & Collaborators

Principal Investigators

  • Tricia A Meyer, PharmD · Scott and White Healthcare

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2010-08-31
Completion
2010-08-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00738621 on ClinicalTrials.gov