2 Doses of an Approved Drug Being Studied for a New Indication for the Prevention of Postoperative Nausea and Vomiting (0869-091)
NCT ID: NCT00090246
Last Updated: 2017-05-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
922 participants
INTERVENTIONAL
2004-05-13
2005-04-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Interventions
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MK0869, aprepitant
Comparator: ondansetron IV
Eligibility Criteria
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Inclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
References
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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.
Diemunsch 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.
Goveia 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.
Study Documents
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Document Type: CSR Snyopsis
View DocumentOther Identifiers
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2004_014
Identifier Type: -
Identifier Source: secondary_id
0869-091
Identifier Type: -
Identifier Source: org_study_id
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