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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00090207 |
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Date of registration:
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25/08/2004 |
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Primary sponsor: |
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Public title:
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Aprepitant for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) Associated With Highly Emetogenic Chemotherapy
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Scientific title:
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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 |
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Date of first enrolment:
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January 2004 |
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Target sample size:
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400 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00090207 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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Countries of recruitment
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United States
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Contacts
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Name:
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Medical Monitor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Merck |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Nausea
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Vomiting
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Intervention(s)
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Drug: Comparator: ondansetron / Duration of Treatment: 4 days
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Drug: MK0869, aprepitant / Duration of Treatment: 3 days
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Primary Outcome(s)
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Patient vomiting
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Secondary Outcome(s)
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Number of rescue therapies
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Secondary ID(s)
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2004_005
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MK0869-801
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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