2 Doses of an Approved Drug Being Studied for a New Indication for the Prevention of Postoperative Nausea and Vomiting (0869-091)

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00090246

Enrollment

922

Registered

2004-08-27

Start date

2004-05-13

Completion date

2005-04-20

Last updated

2017-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Nausea and Vomiting

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.

Interventions

DRUGMK0869, aprepitant

DRUGComparator: ondansetron IV

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Prevention of PONV in the 24 hours following end of surgery; Tolerability	24 hours

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026