Trials / Completed
CompletedNCT00366834
Intravenous And Oral Casopitant (GW679769) For The Prevention Of Chemotherapy Induced Nausea And Vomiting
A Phase III, Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group Study of the Safety and Efficacy of the Intravenous and Oral Formulations of the Neurokinin-1 Receptor Antagonist Casopitant (GW679769) in Combination With Ondansetron and Dexamethasone for the Prevention of Nausea
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,840 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase III trial designed to demonstrate that casopitant (GW679769) plus dexamethasone and ondansetron is more effective in the prevention of vomiting than dexamethasone and ondansetron alone following the administration of moderately emetogenic chemotherapy.
Detailed description
A Phase III, Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group Study of the Safety and Efficacy of the Intravenous and Oral Formulations of the Neurokinin-1 Receptor Antagonist, Casopitant (GW679769) in Combination with Ondansetron and Dexamethasone for the Prevention of Nausea and Vomiting Induced by Moderately Emetogenic Chemotherapy
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Casopitant (GW679769) oral tablets | |
| DRUG | Casopitant (GW679769) intravenous | |
| DRUG | Dexamethasone intravenous | |
| DRUG | Ondansetron oral tablets | |
| DRUG | placebo | casopitant placebo |
Timeline
- Start date
- 2006-07-01
- Primary completion
- 2007-10-01
- Completion
- 2009-10-01
- First posted
- 2006-08-21
- Last updated
- 2012-09-10
Locations
223 sites across 32 countries: United States, Argentina, Austria, Belgium, Bulgaria, Canada, Croatia, Czechia, Denmark, Estonia, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Latvia, Lithuania, Mexico, Pakistan, Peru, Philippines, Poland, Russia, Slovakia, South Africa, South Korea, Spain, Taiwan, Thailand, United Kingdom
Source: ClinicalTrials.gov record NCT00366834. Inclusion in this directory is not an endorsement.