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NCT00954941 · ClinicalTrials.gov registry record · Phase 2
Ondansetron Versus Aprepitant Plus Ondansetron for Emesis
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
NCT00954941: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT00954941 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 100 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00954941, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to compare the effectiveness of receiving a combination of ondansetron and aprepitant to receiving ondansetron alone in helping to prevent nausea and/or vomiting in patients with Acute myeloid leukemia (AML) or high-risk (HR) Myelodysplastic syndromes (MDS) who are receiving cytarabine. The safety of this drug combination will also be studied.
Primary Outcome
Participant response defined as: Complete response - no emetic episode, no nausea and no rescue medication during the administration of chemotherapy; Partial response - less than or equal to one episode of emesis in 24 hours, no rescue medication, and no more than moderate nausea (grade 2 National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)) during chemotherapy. Vomit was defined as expulsion of stomach contents through the mouth, nausea as stomach distress with
Interventions
- DRUG Ondansetron
- DRUG Aprepitant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2009-11 |
| Est. Completion | 2015-05 |
| Phase | Phase 2 |
What the finished NCT00954941 record still lists
NCT00954941 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% lower).
The record links to 0 conditions, and to 2 interventions - of which Ondansetron is the first listed.
NCT00954941 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00954941 about?
NCT00954941 is a clinical study titled "Ondansetron Versus Aprepitant Plus Ondansetron for Emesis". The goal of this clinical research study is to compare the effectiveness of receiving a combination of ondansetron and aprepitant to receiving ondansetron alone in helping to prevent nausea and/or vomiting in patients with Acute myeloid leukemia (AML) or high-risk (HR) Myelodysplastic syndromes (MDS...
What is the current status of trial NCT00954941?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2009-11. Estimated completion is 2015-05.
What interventions are being tested in trial NCT00954941?
The interventions under investigation include: Ondansetron (DRUG), Aprepitant (DRUG).
Who is sponsoring clinical trial NCT00954941?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00954941's enrollment target sits among peer trials
100 672nd of 2000 higher than 1,263 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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