Aprepitant for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) Associated With Highly Emetogenic Chemotherapy (0869-801)(COMPLETED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00090207
Recruitment Status : Completed
First Posted : August 27, 2004
Last Update Posted : April 24, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 477 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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
Actual Study Start Date : January 13, 2004
Actual Primary Completion Date : September 30, 2004
Actual Study Completion Date : September 30, 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Patient vomiting

Secondary Outcome Measures :
  1. Number of rescue therapies

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00090207

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.

Study Data/Documents: CSR Snyopsis  This link exits the site

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00090207     History of Changes
Other Study ID Numbers: 0869-801
First Posted: August 27, 2004    Key Record Dates
Last Update Posted: April 24, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
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
Neurokinin-1 Receptor Antagonists