2 Doses of an Approved Drug Being Studied for a New Indication for the Prevention of Postoperative Nausea and Vomiting - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

August 24, 2004

Last Updated Date

April 24, 2009

Start Date ^†

September 2003

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00090155 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

2 Doses of an Approved Drug Being Studied for a New Indication for the Prevention of Postoperative Nausea and Vomiting

Official Title ^†

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

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.

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Postoperative Nausea and Vomiting

Intervention ^†

Drug: MK0869, aprepitant
Drug: Comparator: ondansetron IV

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

720

Completion Date

Primary Completion Date

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 medication.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00090155

Responsible Party

Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.

Secondary IDs ^††

MK0869-090

Study Sponsor ^†

Merck

Collaborators ^††

Investigators ^†

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

April 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.