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CompletedNCT00090246Updated May 5, 2017

2 Doses of an Approved Drug Being Studied for a New Indication for the Prevention of Postoperative Nausea and Vomiting (0869-091)

A Phase 3 interventional study of MK0869, aprepitant and Comparator: ondansetron IV in Postoperative Nausea and Vomiting, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-05.

Sponsored by Merck Sharp & Dohme LLC · Phase 3, Interventional, and Prevention

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled May 2004, registered Aug 2004).
Phase
Phase 3
Study type
Interventional
Enrollment
922
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

The duration of treatment is 4 weeks.

02

Conditions studied

  • Postoperative Nausea and Vomiting
03

In context

Nausea

822 studies on the registry are indexed under Nausea; 104 are open to participants now.

This study's enrollment of 922 is above the median of 115 across 703 interventional studies indexed under Nausea.

Browse Nausea studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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 opioids.
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
922 participants (actual)

Interventions

  • DrugMK0869, aprepitant
  • DrugComparator: ondansetron IV
06

What researchers measure

Primary outcomes

  1. Prevention of PONV in the 24 hours following end of surgery; Tolerability

    Time frame: 24 hours

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 17540667 ↗
  • 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. PubMed 17845742 ↗
  • 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. PubMed 18520448 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 5, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00090246
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Aug 27, 2004
Start date
May 13, 2004
Primary completion
Apr 6, 2005
Completion
Apr 20, 2005
Last update
May 5, 2017

Study contacts

Medical Monitor
study director · Merck Sharp & Dohme LLC
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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