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
2 other identifiers
interventional
922
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2004
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 13, 2004
CompletedFirst Submitted
Initial submission to the registry
August 25, 2004
CompletedFirst Posted
Study publicly available on registry
August 27, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 6, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
April 20, 2005
CompletedMay 5, 2017
May 1, 2017
11 months
August 25, 2004
May 2, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Prevention of PONV in the 24 hours following end of surgery; Tolerability
24 hours
Interventions
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (3)
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. doi: 10.1093/bja/aem133. Epub 2007 May 30.
PMID: 17540667BACKGROUNDDiemunsch P, Apfel C, Gan TJ, Candiotti K, Philip BK, Chelly J, Carides AD, Evans JK, Ho TW, Reiss T. Preventing postoperative nausea and vomiting: post hoc analysis of pooled data from two randomized active-controlled trials of aprepitant. Curr Med Res Opin. 2007 Oct;23(10):2559-65. doi: 10.1185/030079907X233115.
PMID: 17845742BACKGROUNDGoveia MG, DiNubile MJ, Dallas MJ, Heaton PM, Kuter BJ; REST Study Team. Efficacy of pentavalent human-bovine (WC3) reassortant rotavirus vaccine based on breastfeeding frequency. Pediatr Infect Dis J. 2008 Jul;27(7):656-8. doi: 10.1097/INF.0b013e318168d29e.
PMID: 18520448BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2004
First Posted
August 27, 2004
Study Start
May 13, 2004
Primary Completion
April 6, 2005
Study Completion
April 20, 2005
Last Updated
May 5, 2017
Record last verified: 2017-05