Aprepitant for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) Associated With Highly Emetogenic Chemotherapy - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00090207

Purpose

A multicenter trial to assess the safety and efficacy of an investigational drug in the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with confirmed solid tumors who will be treated with a chemotherapy regimen that includes cisplatin. The study will evaluate the investigational drug for the treatment of CINV during the first cycle of treatment with cisplatin. (INTERNATIONAL STUDY LOCATIONS ONLY)

Condition	Intervention	Phase
Nausea Vomiting	Drug: MK0869, aprepitant / Duration of Treatment: 3 days Drug: Comparator: ondansetron / Duration of Treatment: 4 days	Phase IV

MedlinePlus related topics: Nausea and Vomiting

Drug Information available for: Cisplatin 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, Parallel-Group Study Conducted Under In-House Blinding Conditions to Determine the Safety, Tolerability and Efficacy of Aprepitant Regimen Compared to Ondansetron Regimen for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) Associated With High Dose Cisplatin in Cycle 1

Further study details as provided by Merck:

Primary Outcome Measures:

Patient vomiting

Secondary Outcome Measures:

Number of rescue therparies

Estimated Enrollment:	400
Study Start Date:	January 2004

Eligibility

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

Criteria

Inclusion Criteria:

Patient is greater than 18 years of age.
Patient is scheduled to receive his/her first course of cisplatin chemotherapy for a solid tumor.
Patient has a prognosis (life expectancy) greater than or equal to 3 months.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00090207

Locations

United States, Pennsylvania
Call for International Site Information
Horsham, Pennsylvania, United States, 19044

Sponsors and Collaborators

Merck

More Information

Publications:

Schmoll HJ, Aapro MS, Poli-Bigelli S, Kim HK, Park K, Jordan K, von Pawel J, Giezek H, Ahmed T, Chan CY. Comparison of an aprepitant regimen with a multiple-day ondansetron regimen, both with dexamethasone, for antiemetic efficacy in high-dose cisplatin treatment. Ann Oncol. 2006 Jun;17(6):1000-6. Epub 2006 Mar 8.

Study ID Numbers:	2004_005
Study First Received:	August 25, 2004
Last Updated:	November 27, 2006
ClinicalTrials.gov Identifier:	NCT00090207
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Signs and Symptoms
Vomiting
Cisplatin
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
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