Trials / Completed
CompletedNCT00601172
A Study Of IV Casopitant For The Prevention Of Chemotherapy Induced Nausea And Vomiting.
A Study of Single Dose Intravenous Casopitant in Combination With Ondansetron and Dexamethasone for the Prevention of Oxaliplatin Induced Nausea and Vomiting.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 710 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This a Phase III trial designed to determine if IV casopitant plus dexamethasone and ondansetron is more effective in the prevention of vomiting and nausea then dexamethasone and ondansetrone alone following the administration of moderately emetogenic oxaliplatin-based chemotherapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Casopitant | Experimental NK-1 receptor antagonist |
| DRUG | Dexamethasone | Standard antiemetics |
| DRUG | Placebo | Placebo to match IV casopitant |
| DRUG | Ondansetron | Standard antiemetics |
Timeline
- Start date
- 2008-03-10
- Primary completion
- 2009-04-13
- Completion
- 2009-04-13
- First posted
- 2008-01-25
- Last updated
- 2018-01-17
- Results posted
- 2018-01-17
Locations
96 sites across 11 countries: United States, Belgium, Bulgaria, Canada, Czechia, Germany, Hungary, Italy, Russia, Slovakia, South Korea
Source: ClinicalTrials.gov record NCT00601172. Inclusion in this directory is not an endorsement.