2 Doses of an Approved Drug Being Studied for a New Indication for the Prevention of Postoperative Nausea and Vomiting
Information source: Merck
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postoperative Nausea and Vomiting
Intervention: MK0869, aprepitant (Drug); Comparator: ondansetron IV (Drug)
Phase: Phase 3
Sponsored by: Merck
Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
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.
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
Study design: Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Prevention of PONV in the 24 hours following end of surgery; Tolerability
The duration of treatment is 4 weeks.
Minimum age: 18 Years.
Maximum age: N/A.
- 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.
Locations and Contacts
Diemunsch P, Gan TJ, Philip BK, Girao MJ, Eberhart L, Irwin MG, Pueyo J, Chelly JE, Carides AD, Reiss T, Evans JK, Lawson FC; Aprepitant-PONV Protocol 091 International Study Group. Single-dose aprepitant vs ondansetron for the prevention of postoperative nausea and vomiting: a randomized, double-blind phase III trial in patients undergoing open abdominal surgery. Br J Anaesth. 2007 Aug;99(2):202-11. Epub 2007 May 30.
Starting date: May 2004
Last updated: October 8, 2007