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NCT00090246 Clinical Trial

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

Postoperative Nausea and Vomiting Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00090246
Other study ID # 0869-091
Secondary ID 2004_014
Status Completed
Phase Phase 3
First received August 25, 2004
Last updated May 2, 2017
Start date May 13, 2004
Est. completion date April 20, 2005

Study information
Verified date May 2017
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

The duration of treatment is 4 weeks.

Recruitment information / eligibility
Status Completed
Enrollment 922
Est. completion date April 20, 2005
Est. primary completion date April 6, 2005
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• MK0869, aprepitant

• Comparator: ondansetron IV

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

References & Publications (3)

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. — View Citation

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. Epub 2007 May 30. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Prevention of PONV in the 24 hours following end of surgery; Tolerability 24 hours
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