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NCT01370408 · ClinicalTrials.gov registry record · Phase 2
Palonosetron, Ondansetron, and Dexamethasone for Delayed Nausea and Vomiting in Autologous Transplant Patients
A Phase 2 study, sponsored by Northside Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 85
- Enrollment target
NCT01370408: Completed Phase 2 study, sponsored by Northside Hospital.
NCT01370408 is a Phase 2 study that has completed, run by Northside Hospital. The registered enrollment target is 85 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (36% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01370408, a Phase 2 study, has completed, sponsored by Northside Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 85 participants
- Enrollment target
Study Summary
In this study, patients will receive ondansetron 8mg and dexamethasone 10mg intravenously 30 minutes prior to myeloablative preparative chemotherapy until the last day of chemotherapy. On the final day of chemotherapy, palonosetron 0.25mg and dexamethasone 10mg will be administered intravenously 30 minutes prior to the chemotherapy. If the chemotherapy regimen is only 1 day of the chemotherapy then only palonosetron and dexamethasone will be administered 30 minutes prior to chemotherapy. Dexamethasone 8mg once daily will be given orally for 2 days following chemotherapy.
Primary Outcome
Proportion of patients achieving a delayed CINV complete response (CR) defined as no emetic episode and no use of rescue medications during the 24-120 hour period post chemotherapy.
Interventions
- DRUG Dexamethasone
- DRUG Palonosetron
- DRUG ondansetron
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2012-02 |
| Est. Completion | 2016-03 |
| Phase | Phase 2 |
What the finished NCT01370408 record still lists
NCT01370408 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 85 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (36% lower).
The record links to 0 conditions, and to 3 interventions - of which Dexamethasone is the first listed.
NCT01370408 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01370408 about?
NCT01370408 is a clinical study titled "Palonosetron, Ondansetron, and Dexamethasone for Delayed Nausea and Vomiting in Autologous Transplant Patients". In this study, patients will receive ondansetron 8mg and dexamethasone 10mg intravenously 30 minutes prior to myeloablative preparative chemotherapy until the last day of chemotherapy. On the final day of chemotherapy, palonosetron 0.25mg and dexamethasone 10mg will be administered intravenously 30 ...
What is the current status of trial NCT01370408?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 85 participants. The study started on 2012-02. Estimated completion is 2016-03.
What interventions are being tested in trial NCT01370408?
The interventions under investigation include: Dexamethasone (DRUG), Palonosetron (DRUG), ondansetron (DRUG).
Who is sponsoring clinical trial NCT01370408?
This trial is sponsored by Northside Hospital, which has 26 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01370408's enrollment target sits among peer trials
85 820th of 2000 higher than 1,179 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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