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NCT00601172 · ClinicalTrials.gov registry record · Phase 3
A Study Of IV Casopitant For The Prevention Of Chemotherapy Induced Nausea And Vomiting.
A Phase 3 study of Nausea and Vomiting, Chemotherapy-Induced, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 710
- Enrollment target
- 20
- Study locations
NCT00601172: Completed Phase 3 study of Nausea and Vomiting, Chemotherapy-Induced, sponsored by GlaxoSmithKline.
NCT00601172 is a Phase 3 study of Nausea and Vomiting, Chemotherapy-Induced that has completed, run by GlaxoSmithKline. The registered enrollment target is 710 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00601172, a Phase 3 study of Nausea and Vomiting, Chemotherapy-Induced, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 710 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Complete response was defined as no vomiting, no retching and no use of anti-emetic rescue medication. Participants who vomited or retched or received rescue medication in the acute phase (0- 24 hours) following administration of oxaliplatin were also considered as complete response failures in the subsequent delayed (24-120 hour) time period, irrespective of actual response in the delayed phase. However, participants who vomited or retched or received rescue medication in the delayed (24-120 ho
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Dexamethasone
- DRUG Ondansetron
- DRUG Casopitant
Study Locations (20)
California
- GSK Investigational Site - Corona
- GSK Investigational Site - Fountain Valley
- GSK Investigational Site - Riverside
South Carolina
- GSK Investigational Site - Hilton Head Island
- GSK Investigational Site - Mt. Pleasant
- GSK Investigational Site - Sumter
Florida
- GSK Investigational Site - St. Petersburg
- GSK Investigational Site - Tampa
Louisiana
- GSK Investigational Site - Alexandria
- GSK Investigational Site - Baton Rouge
Massachusetts
- GSK Investigational Site - Boston
- GSK Investigational Site - Worcester
Texas
- GSK Investigational Site - Corpus Christi
- GSK Investigational Site - Corpus Christi
Arkansas
- GSK Investigational Site - Hot Springs
Maryland
- GSK Investigational Site - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 710 participants |
| Start Date | 2008-03-10 |
| Est. Completion | 2009-04-13 |
| Phase | Phase 3 |
What the finished NCT00601172 record still lists
NCT00601172 is an interventional study that assigns participants to a tested intervention. The registered 710 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 1 condition, with Nausea and Vomiting, Chemotherapy-Induced appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT00601172 names 20 study sites across 12 states, led by California, South Carolina, Florida.
Frequently Asked Questions
What is clinical trial NCT00601172 about?
NCT00601172 is a clinical study titled "A Study Of IV Casopitant For The Prevention Of Chemotherapy Induced Nausea And Vomiting.". 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.
What is the current status of trial NCT00601172?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 710 participants. The study started on 2008-03-10. Estimated completion is 2009-04-13.
What conditions does trial NCT00601172 study?
This clinical trial studies the following conditions: Nausea and Vomiting, Chemotherapy-Induced.
What interventions are being tested in trial NCT00601172?
The interventions under investigation include: Placebo (DRUG), Dexamethasone (DRUG), Ondansetron (DRUG), Casopitant (DRUG).
Who is sponsoring clinical trial NCT00601172?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00601172 being conducted?
This trial has 20 study locations across Arkansas, California, Florida, Louisiana, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00601172's enrollment target sits among peer trials
710 502nd of 2000 higher than 1,496 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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