drugset / Trial / NCT00104403
Study Of Prevention of Chemo-Induced Nausea and Vomiting Caused By Moderately Emetogenic Chemotherapy
RandomizedParallel-groupDouble-blindTreatment
Summary
This study was designed to assess the safety and efficacy of different dosages and administration schedules of an investigational agent administered over 3 days when added to standard therapy used in the prevention of chemotherapy-induced nausea and vomiting in cancer patients. Subjects will be asked to complete daily diaries while on study medication. In addition subjects will be required to return to the investigational site several times during the course of the study for follow up safety assessments which may include blood samples for hematology and chemistry evaluations as well as physical exams. A final assessment will be preformed on study Day 20-30 at which time the subject will complete the study.
Timeline
- Start
- 2004-12
- Primary completion
- 2006-01
- Completion
- 2006-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Casopitant | Small molecule | 50 mg | Oral |
| Subject | Casopitant | Small molecule | 100 mg | Oral |
| Subject | Casopitant | Small molecule | 150 mg | Oral |
| Background | Dexamethasone | Small molecule | — | — |
| Background | Ondansetron | Other / unclassified | — | — |