A Randomized, Double-Blind, Active Comparator-Controlled, Parallel-Group Study, Conducted Under In-House Blinding Conditions, to Examine the Safety, Tolerability, and Efficacy of 2 Doses of Aprepitant for the Prevention of Postoperative Nausea and Vomiting

Merck Sharp & Dohme LLC0 sites922 target enrollmentMay 13, 2004

ConditionsPostoperative Nausea and Vomiting

DrugsMK0869, aprepitant Comparator: ondansetron IV

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Postoperative Nausea and Vomiting
Sponsor: Merck Sharp & Dohme LLC
Enrollment: 922
Primary Endpoint: Prevention of PONV in the 24 hours following end of surgery; Tolerability
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study is to assess the safety and efficacy of 2 doses of an approved drug for a new indication in the prevention of postoperative nausea and vomiting in patients receiving general anesthesia for open abdominal surgery requiring overnight hospital stay.

Detailed Description

The duration of treatment is 4 weeks.

Registry

clinicaltrials.gov

Start Date

May 13, 2004

End Date

April 20, 2005

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Merck Sharp & Dohme LLC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient is at least 18 years of age.
•Patient is scheduled to undergo open abdominal surgery requiring overnight hospital stay (24-hour hospital stay after end of surgery).
•Patient is scheduled to receive general anesthesia.
•Patient is scheduled to receive postoperative opioids.