Trials / Completed
CompletedNCT00104403
Study Of Prevention of Chemo-Induced Nausea and Vomiting Caused By Moderately Emetogenic Chemotherapy
A Phase II Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging, Parallel Group Study of the Safety and Efficacy of the Oral NeuroKinin-1 Receptor Antagonist, GW679769 in Combination With Ondansetron Hydrochloride and Dexamethasone for the Prevention of Chemotherapy-Induced Nausea
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 722 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
A Phase II Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging, Parallel Group Study of the Safety and Efficacy of the Oral NeuroKinin-1 Receptor Antagonist, GW679769 in Combination with Ondansetron Hydrochloride and Dexamethasone for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Cancer Subjects Receiving Moderately Emetogenic Chemotherapy
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GW679769 | |
| DRUG | Dexamethasone | |
| DRUG | Ondansetron Hydrochloride |
Timeline
- Start date
- 2004-12-01
- Primary completion
- 2006-01-01
- Completion
- 2006-01-01
- First posted
- 2005-03-01
- Last updated
- 2015-04-16
Locations
113 sites across 24 countries: United States, Argentina, Austria, Canada, Chile, Croatia, Czechia, Germany, Greece, Hong Kong, Hungary, Ireland, Mexico, Pakistan, Philippines, Poland, Portugal, Russia, Singapore, Slovakia, Spain, Taiwan, Thailand, United Kingdom
Source: ClinicalTrials.gov record NCT00104403. Inclusion in this directory is not an endorsement.