NCT00090155CompletedPhase 3
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
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 805
- Primary Endpoint
- Prevention of PONV in the 24 hours following end of surgery; Tolerability
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Prevention of PONV in the 24 hours following end of surgery; Tolerability
Secondary Outcomes
No secondary outcomes reported
Investigators
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