CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 150 enrolled
Drug / intervention
Aprepitant plus Ondansetron +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00659945
NCT00659945Phase 4Completed
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Efficacy of Pre-operative Aprepitant Plus Ondansetron vs Ondansetron Plus Placebo in Patients at Moderate-to-High Risk Post-operative Nausea (PONV) Undergoing Ambulatory Plastic Surgery

University of Pittsburgh·interventional·Posted Apr 17, 2008·Updated Feb 6, 2013

In Brief

A Phase 4 clinical trial evaluating Aprepitant plus Ondansetron and Ondansetron plus placebo for Postoperative Nausea and Vomiting. Completed, enrolled 150 participants across 1 site.

Detailed Summary

Hypothesis: Aprepitant plus ondansetron is more effective than ondansetron plus placebo for prevention of postoperative emesis in patients at moderate-to-high risk for PONV for up to 48 hours after surgery. Specific Aim: To determine the incidence of PONV during the first 48 hours after surgery; in patients who have received aprepitant plus ondansetron versus ondansetron plus placebo for up to 48 hours after surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostoperative Nausea and Vomiting
CountriesUnited States
CollaboratorsMerck Sharp & Dohme LLC

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 17, 2008
Enrollment StartJun 1, 2008
Primary CompletionNov 1, 2009
Study CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 18.2 years ago

Interventions

Aprepitant plus Ondansetrondrug

Aprepitant plus Ondansetron

Ondansetron plus placebodrug

Ondansetron plus placebo