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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 27 May 2013
Main ID:  NCT00090207
Date of registration: 25/08/2004
Primary sponsor: Merck
Public title: Aprepitant for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) Associated With Highly Emetogenic Chemotherapy (0869-801)(COMPLETED)
Scientific 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
Date of first enrolment: January 2004
Target sample size: 400
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00090207
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention  
Countries of recruitment
United States
Contacts
Name:   Medical Monitor
Address: 
Telephone:
Email:
Affiliation:  Merck
Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Nausea
Vomiting
Intervention(s)
Drug: Comparator: ondansetron / Duration of Treatment: 4 days
Drug: MK0869, aprepitant / Duration of Treatment: 3 days
Primary Outcome(s)
Patient vomiting
Secondary Outcome(s)
Number of rescue therapies
Secondary ID(s)
2004_005
MK0869-801
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
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