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NCT00659945 · ClinicalTrials.gov registry record · Phase 4
Aprepitant for PONV Prophylaxis in Outpatient Plastic Surgery
A Phase 4 study, sponsored by University of Pittsburgh.
- Completed
- Registry status
- Phase 4
- Development phase
- 150
- Enrollment target
NCT00659945: Completed Phase 4 study, sponsored by University of Pittsburgh.
NCT00659945 is a Phase 4 study that has completed, run by University of Pittsburgh. The registered enrollment target is 150 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00659945, a Phase 4 study, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 150 participants
- Enrollment target
Study 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.
Primary Outcome
Postoperative emesis was measured as present or not present (nominal data) and analyzed with Chi-square; Comparison of nausea severity was performed in two ways. In those patients who exhibited nausea VRS\>0, a worst nausea score for each patient was defined as the highest nausea score recorded over the 48 hours. Mann-Whitney rank sum test was used to compare worst nausea scores. Multivariate Analysis of Variance (MANOVA) was used to determine if the mean VRS (Verbal Rating Scale) score over tim
Interventions
- DRUG Aprepitant plus Ondansetron
- DRUG Ondansetron plus placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2008-06 |
| Est. Completion | 2010-06 |
| Phase | Phase 4 |
What the finished NCT00659945 record still lists
NCT00659945 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 2 interventions - of which Aprepitant plus Ondansetron is the first listed.
NCT00659945 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00659945 about?
NCT00659945 is a clinical study titled "Aprepitant for PONV Prophylaxis in Outpatient Plastic Surgery". 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...
What is the current status of trial NCT00659945?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 150 participants. The study started on 2008-06. Estimated completion is 2010-06.
What interventions are being tested in trial NCT00659945?
The interventions under investigation include: Aprepitant plus Ondansetron (DRUG), Ondansetron plus placebo (DRUG).
Who is sponsoring clinical trial NCT00659945?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00659945's enrollment target sits among peer trials
150 533rd of 2000 higher than 1,436 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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