Back to results2 Doses of an Approved Drug Being Studied for a New Indication for the Prevention of Postoperative Nausea and Vomiting (0869-090)(COMPLETED)
Primary Purpose
Postoperative Nausea and Vomiting
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK0869, aprepitant
Comparator: ondansetron IV
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Nausea and Vomiting
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.
Sites / Locations
Outcomes
Primary Outcome Measures
Prevention of PONV in the 24 hours following end of surgery; Tolerability
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00090155
Brief Title
2 Doses of an Approved Drug Being Studied for a New Indication for the Prevention of Postoperative Nausea and Vomiting (0869-090)(COMPLETED)
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 Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
September 26, 2003 (Actual)
Primary Completion Date
November 24, 2004 (Actual)
Study Completion Date
November 24, 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
805 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0869, aprepitant
Intervention Type
Drug
Intervention Name(s)
Comparator: ondansetron IV
Primary Outcome Measure Information:
Title
Prevention of PONV in the 24 hours following end of surgery; Tolerability
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
17456656
Citation
Gan TJ, Apfel CC, Kovac A, Philip BK, Singla N, Minkowitz H, Habib AS, Knighton J, Carides AD, Zhang H, Horgan KJ, Evans JK, Lawson FC; Aprepitant-PONV Study Group. A randomized, double-blind comparison of the NK1 antagonist, aprepitant, versus ondansetron for the prevention of postoperative nausea and vomiting. Anesth Analg. 2007 May;104(5):1082-9, tables of contents. doi: 10.1213/01.ane.0000263277.35140.a3.
Results Reference
background
PubMed Identifier
17845742
Citation
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.
Results Reference
background
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis
Available IPD/Information URL
http://www.merck.com/clinical-trials/policies-perspectives.html
Learn more about this trial
2 Doses of an Approved Drug Being Studied for a New Indication for the Prevention of Postoperative Nausea and Vomiting (0869-090)(COMPLETED)
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