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

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 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention
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

Resource links provided by NLM:

MedlinePlus related topics: Nausea and Vomiting

Drug Information available for: Ondansetron hydrochloride Ondansetron Aprepitant Fosaprepitant Fosaprepitant dimeglumine

U.S. FDA Resources

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
Primary Completion Date:	November 2004 (Final data collection date for primary outcome measure)

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.

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.

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00090155 History of Changes
Other Study ID Numbers:	2004_011, MK0869-090
Study First Received:	August 24, 2004
Last Updated:	May 20, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Ondansetron
Aprepitant
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents

ClinicalTrials.gov processed this record on May 23, 2013