2 Doses of an Approved Drug Being Studied for a New Indication for the Prevention of Postoperative Nausea and Vomiting (0869-090)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00090155
First received: August 24, 2004
Last updated: November 26, 2013
Last verified: November 2013

August 24, 2004
November 26, 2013
September 2003
November 2004   (final data collection date for primary outcome measure)
Prevention of PONV in the 24 hours following end of surgery; Tolerability
Not Provided
Complete list of historical versions of study NCT00090155 on ClinicalTrials.gov Archive Site
Not Provided
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2 Doses of an Approved Drug Being Studied for a New Indication for the Prevention of Postoperative Nausea and Vomiting (0869-090)(COMPLETED)
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

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.

The duration of treatment is 4 weeks.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Postoperative Nausea and Vomiting
  • Drug: MK0869, aprepitant
  • Drug: Comparator: ondansetron IV
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
805
November 2004
November 2004   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00090155
0869-090, 2004_011
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP