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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


Phase 3
12 Years
17 Years
Not Enrolling
Both
Vomiting

Thank you

Trial Information

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


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

Inclusion 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Outcome Measure:

Drug-related adverse experiences

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Merck

Authority:

United States: Food and Drug Administration

Study ID:

2004_099

NCT ID:

NCT00080444

Start Date:

April 2004

Completion Date:

March 2007

Related Keywords:

  • Vomiting
  • Vomiting

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