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NCT01450826 · ClinicalTrials.gov registry record · Phase 2
Emend and Ondansetron Compared to Ondansetron Alone to Prevent CINV in Glioma Patients Receiving Temozolomide
A Phase 2 study, sponsored by Katy Peters.
- Completed
- Registry status
- Phase 2
- Development phase
- 136
- Enrollment target
NCT01450826: Completed Phase 2 study, sponsored by Katy Peters.
NCT01450826 is a Phase 2 study that has completed, run by Katy Peters. The registered enrollment target is 136 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01450826, a Phase 2 study, has completed, sponsored by Katy Peters.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 136 participants
- Enrollment target
Study Summary
Patients diagnosed with malignant glioma who are receiving temozolomide will be accrued in this open label, phase 2, randomized single institution trial of aprepitant in combination with ondansetron versus ondansetron alone for the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV). Sixty-eight (68) patients will be randomized to each arm of the study.
Primary Outcome
Complete control (CC): study days 1-7 (acute and delayed CINV) the proportion of patients achieving complete control (CC); defined as no emetic episode, no need for rescue medication during days 1-7; number of emetic episodes daily; time to first emetic episode; as captured by the MAT (MASCC Antiemesis Tool)/Osoba survey (MASCC refers to Multinational Association for Supportive Care in Cancer™). Severity of nausea and other toxicities measured daily by the NCI Common Toxicity Criteria (version 4
Interventions
- DRUG ondansetron
- DRUG aprepitant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 136 participants |
| Start Date | 2014-06-24 |
| Est. Completion | 2017-04-21 |
| Phase | Phase 2 |
What the finished NCT01450826 record still lists
NCT01450826 is an interventional study that assigns participants to a tested intervention. The registered 136 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which ondansetron is the first listed.
NCT01450826 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01450826 about?
NCT01450826 is a clinical study titled "Emend and Ondansetron Compared to Ondansetron Alone to Prevent CINV in Glioma Patients Receiving Temozolomide". Patients diagnosed with malignant glioma who are receiving temozolomide will be accrued in this open label, phase 2, randomized single institution trial of aprepitant in combination with ondansetron versus ondansetron alone for the prevention of acute and delayed chemotherapy-induced nausea and vomi...
What is the current status of trial NCT01450826?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 136 participants. The study started on 2014-06-24. Estimated completion is 2017-04-21.
What interventions are being tested in trial NCT01450826?
The interventions under investigation include: ondansetron (DRUG), aprepitant (DRUG).
Who is sponsoring clinical trial NCT01450826?
This trial is sponsored by Katy Peters, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01450826's enrollment target sits among peer trials
136 527th of 2000 higher than 1,469 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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