Study of MK0869 for Chemotherapy-Induced Nausea and Vomiting in Adolescent Patients

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

Secondary outcome:

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

Detailed description: The duration of treatment is 4 days, up to 10 cycles.

Minimum age: 12 Years. Maximum age: 17 Years. Gender(s): Both.

Criteria:

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.

Starting date: April 2004
Last updated: September 15, 2006