Study of MK0869 for Chemotherapy-Induced Nausea and Vomiting in Adolescent Patients
Information source: Merck
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Vomiting
Intervention: MK0869, aprepitant (Drug); Comparator: ondansetron and dexamethasone (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Merck
Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
To demonstrate that MK0869 prevents nausea and vomiting caused by emetogenic cancer
chemotherapy in adolescent patients.
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study, Conducted Under In-House Blinding Conditions, to Examine the Safety, Tolerability, and Efficacy of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting Associated With Emetogenic Chemotherapy in Adolescent Patients
Study design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study
Primary outcome: Drug-related adverse experiences
Serious adverse experiences including drug related and discontinuation of the study due to drug related adverse experiences
Efficacy against nausea and vomiting during 4 days of treatment
The duration of treatment is 4 days, up to 10 cycles.
Minimum age: 12 Years.
Maximum age: 17 Years.
Patient is to be treated with an emetogenic chemotherapy regimen that includes either
cisplatin, cyclophosphamide, or carboplatin, for a documented solid malignancy, for either
1 day or 2 consecutive days OR Patient did not tolerate a previously administered
chemotherapy regimen, for a documented solid malignancy, secondary to nausea and/or
vomiting that is planned to be repeated.
Locations and Contacts
Starting date: April 2004
Last updated: September 15, 2006