2 Doses of an Approved Drug Being Studied for a New Indication for the Prevention of Postoperative Nausea and Vomiting - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00090155

Purpose

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.

Condition	Intervention	Phase
Postoperative Nausea and Vomiting	Drug: MK0869, aprepitant Drug: Comparator: ondansetron IV	Phase III

MedlinePlus related topics: Nausea and Vomiting

Drug Information available for: Ondansetron Ondansetron hydrochloride Aprepitant

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Merck:

Primary Outcome Measures:

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

Estimated Enrollment:	720
Study Start Date:	September 2003

Detailed Description:

The duration of treatment is 4 weeks.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 medication.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00090155

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Publications:

Gan TJ, Apfel CC, Kovac A, Philip BK, Singla N, Minkowitz H, Habib AS, Knighton J, Carides AD, Zhang H, Horgan KJ, Evans JK, Lawson FC; Aprepitant-PONV Study Group. A randomized, double-blind comparison of the NK1 antagonist, aprepitant, versus ondansetron for the prevention of postoperative nausea and vomiting. Anesth Analg. 2007 May;104(5):1082-9, tables of contents.

Publications indexed to this study:

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.

Study ID Numbers:	2004_011
Study First Received:	August 24, 2004
Last Updated:	May 17, 2007
ClinicalTrials.gov Identifier:	NCT00090155
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Signs and Symptoms
Postoperative Nausea and Vomiting
Vomiting
Postoperative Complications
Signs and Symptoms, Digestive

Nausea
Ondansetron
Serotonin
Aprepitant

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Gastrointestinal Agents
Central Nervous System Depressants
Antiemetics
Antipsychotic Agents
Pharmacologic Actions

Serotonin Antagonists
Pathologic Processes
Serotonin Agents
Autonomic Agents
Therapeutic Uses
Antipruritics
Anti-Anxiety Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on January 14, 2009